Rotator Cuff Injuries
Conditions
Keywords
Rotator cuff tendon, Full thickness tears, REGENETEN Bioinductive Implant System
Brief summary
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
Detailed description
This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.
Interventions
DEVICEArthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
PROCEDUREArthroscopic rotator cuff repair
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
DEVICEArthroscopic rotator cuff repair for revision surgery
The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject requires Arthroscopic rotator cuff repair (ARCR); 2. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed; 3. Subject is \> 40 years of age (no upper limit); 4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form; 5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
Exclusion criteria
1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications; 2. Subjects with Samilson-Prieto osteoarthritis \> 2; 3. Subjects with current or prior infection of the ipsilateral shoulder; 4. Subjects with known hypersensitivity to bovine-derived materials; 5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease; 6. Subjects with prior shoulder surgery (not including rotator cuff repair \[revision repair subject group only\], biceps tenodesis/tenotomy, distal clavicle excision \[DCE\], subacromial decompression); 7. Subjects with an irreparable or partially reparable rotator cuff tear; 8. Subjects with a subscapularis tear requiring repair; 9. Subjects requiring a concomitant labral fixation procedure; 10. Subjects requiring a concomitant os acromiale fixation procedure; 11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations); 12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery; 13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., \> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks; 14. Subjects who are pregnant or breast feeding; 15. Subjects who are currently involved in any injury litigation or workers compensation claims; 16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study; 17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation 18. Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse; 19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs); 20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retear Rate at 6 Months | 6 months | Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Shoulder Score (OSS) | Baseline, 3 months, 6 months, 12 months and 24 months | The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes. |
| Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | Baseline, 3 months, 6 months, 12 months and 24 months | The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome). |
| Constant-Murley Score | Baseline, 3 months, 6 months, 12 months and 24 months | The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome). |
| Subjective Shoulder Value (SSV) | Baseline, 3 months, 6 months, 12 months and 24 months | The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome. |
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline, 3 months, 6 months, 12 months and 24 months | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome. |
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | Baseline, 3 months, 6 months, 12 months and 24 months | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome). |
| Patient Satisfaction Questionnaire: Medical Care | Baseline, 3 months, 6 months, 12 months and 24 months | The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question How satisfied are you with your medical care?. Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied. |
| Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months, 6 months, 12 months and 24 months | The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery relieve the pain? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor |
| Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months, 6 months, 12 months and 24 months | The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery improve your ability to perform regular activities? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor |
| Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months, 6 months, 12 months and 24 months | The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery allow you to perform heavy work or sport activities? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor |
| Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months, 6 months, 12 months and 24 months | The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery meet your expectations? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor |
| Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months, 6 months, 12 months and 24 months | The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, Would you repeat the operation again if needed on another joint? with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not |
| Pain - Visual Analog Scale (VAS) Score | 2 weeks, 6 weeks, 3 months and 6 months | Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome). |
| MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months, 6 months, 12 months and 24 months | The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. |
| MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months, 6 months, 12 months and 24 months | The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. |
| MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months, 6 months, 12 months and 24 months | Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess |
| MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months, 6 months, 12 months and 24 months | Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess |
| Number of Retears at 3 Months, 12 Months, and 24 Months | 3 months, 12 months, and 24 months | Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images). |
| Total Tendon Length | 3 months, 6 months, 12 months and 24 months | Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI). |
| Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | Day 0, 3 months and 6 months | Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). |
| Size of Retear: Anteroposterior (AP) Length | Day 0, 3 months and 6 months | Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). |
| Size of Retear: Mediolateral (ML) Length | Day 0, 3 months and 6 months | Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI). |
| Shape of Retear: Operative Visit | Day 0 | Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine |
| Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months, 6 months, 12 months and 24 months | Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine |
| Return to Work Questionnaire | 2 weeks, 6 weeks, 3 months and 6 months | Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness? |
| Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks, 6 weeks, 3 months, 6 months | The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the Returned to work? question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other |
| Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks, 6 weeks, 3 months, 6 months | The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the Have you been able to return to the job you did before your surgery? question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other |
| Return to Work Questionnaire: Time Off | 2 weeks, 6 weeks, 3 months, 6 months | Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the Since returning to work, any time off due to shoulder pain or weakness? question were asked to provide how long they have taken off in days. |
| Return to Work Questionnaire: Duration Away From Work (Days) | 2 weeks, 6 weeks, 3 months, 6 months | Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the Returned to work? question were asked to provide the number of days taken away from work |
| Duration of Opioid Use | Following surgery, up to 14 days | Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery. |
| Opioid Use for More Than 5 Days Post-Surgery | Following surgery, up to 14 days | Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery. |
| Total Operative Time | Intraoperative | Total operative time in minutes. |
| Sling Type | up to 3 months | The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing |
| Mobilization Time in Sling | up to 3 months | Mobilization time was the duration, measured in weeks, that participants spent in a sling. |
| Total Tendon Thickness | 3 months, 6 months, 12 months and 24 months | Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI). |
Countries
Australia, Canada, France, Hong Kong, Singapore, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
Overall, 119 participants were enrolled to the study at 15 sites.
Participants by arm
| Arm | Count |
|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. | 47 |
| ARCR Alone The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Arthroscopic rotator cuff repair: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement. | 48 |
| Revision Group Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Arthroscopic rotator cuff repair for revision surgery: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure. | 24 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Device not used | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Protocol Deviation | 0 | 1 | 0 |
| Overall Study | Reoperation | 1 | 1 | 0 |
| Overall Study | Screen Failures | 0 | 0 | 2 |
| Overall Study | Site Terminated by Sponsor | 1 | 1 | 1 |
| Overall Study | Study Terminated by Sponsor | 31 | 29 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject & Study Terminated by Sponsor | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | ARCR Augmented With REGENETEN™ Bioinductive Implant | ARCR Alone | Revision Group | Total |
|---|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 7.6 | 62.2 years STANDARD_DEVIATION 8.7 | 58.3 years STANDARD_DEVIATION 9.2 | 61.5 years STANDARD_DEVIATION 8.5 |
| Body Mass Index (BMI) | 29.7 kg/m^2 STANDARD_DEVIATION 6 | 29.5 kg/m^2 STANDARD_DEVIATION 5.8 | 28.3 kg/m^2 STANDARD_DEVIATION 5.4 | 29.3 kg/m^2 STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 41 Participants | 21 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Aboriginal and Torres Strait Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian Indian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black / African American | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Chinese | 3 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Japanese | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Korean | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Vietnamese | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White / Caucasian | 43 Participants | 37 Participants | 22 Participants | 102 Participants |
| Sex: Female, Male Female | 16 Participants | 21 Participants | 5 Participants | 42 Participants |
| Sex: Female, Male Male | 31 Participants | 27 Participants | 19 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 | 0 / 24 |
| other Total, other adverse events | 16 / 47 | 11 / 48 | 4 / 24 |
| serious Total, serious adverse events | 2 / 47 | 6 / 48 | 4 / 24 |
Outcome results
Primary
Retear Rate at 6 Months
Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Time frame: 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Retear Rate at 6 Months | 57.14 percentage of retears |
| ARCR Alone | Retear Rate at 6 Months | 50.00 percentage of retears |
| Revision Group | Retear Rate at 6 Months | 42.11 percentage of retears |
Secondary
Constant-Murley Score
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Six participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Constant-Murley Score | 24 months | 58.5 score on a scale | Standard Deviation 3.5 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Constant-Murley Score | 6 months | 57.0 score on a scale | Standard Deviation 13 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Constant-Murley Score | Baseline | 56.5 score on a scale | Standard Deviation 13.5 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Constant-Murley Score | 12 months | 59.1 score on a scale | Standard Deviation 13.8 |
| ARCR Alone | Constant-Murley Score | 24 months | 51.0 score on a scale | Standard Deviation 11.3 |
| ARCR Alone | Constant-Murley Score | Baseline | 54.9 score on a scale | Standard Deviation 13.7 |
| ARCR Alone | Constant-Murley Score | 3 months | 55.0 score on a scale | — |
| ARCR Alone | Constant-Murley Score | 6 months | 53.7 score on a scale | Standard Deviation 12.3 |
| ARCR Alone | Constant-Murley Score | 12 months | 57.2 score on a scale | Standard Deviation 10.7 |
| Revision Group | Constant-Murley Score | Baseline | 55.6 score on a scale | Standard Deviation 16.8 |
| Revision Group | Constant-Murley Score | 3 months | 43.4 score on a scale | — |
| Revision Group | Constant-Murley Score | 6 months | 53.4 score on a scale | Standard Deviation 9.4 |
Secondary
Duration of Opioid Use
Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Time frame: Following surgery, up to 14 days
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Duration of Opioid Use | 7.9 days | Standard Deviation 4.9 |
| ARCR Alone | Duration of Opioid Use | 7.1 days | Standard Deviation 4.5 |
| Revision Group | Duration of Opioid Use | 6.3 days | Standard Deviation 4.9 |
Secondary
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline | 0.618 score on a scale | Standard Deviation 0.186 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 months | 0.719 score on a scale | Standard Deviation 0.227 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 6 months | 0.781 score on a scale | Standard Deviation 0.216 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 months | 0.679 score on a scale | Standard Deviation 0.2 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 3 months | 0.720 score on a scale | Standard Deviation 0.194 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 6 months | 0.786 score on a scale | Standard Deviation 0.232 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline | 0.574 score on a scale | Standard Deviation 0.229 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 3 months | 0.649 score on a scale | Standard Deviation 0.206 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 12 months | 0.805 score on a scale | Standard Deviation 0.256 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 24 months | 0.919 score on a scale | Standard Deviation 0.115 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | Baseline | 0.597 score on a scale | Standard Deviation 0.216 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 6 months | 0.834 score on a scale | Standard Deviation 0.165 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score | 3 months | 0.776 score on a scale | Standard Deviation 0.173 |
Secondary
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | Baseline | 73.4 score on a scale | Standard Deviation 15.4 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 3 months | 74.2 score on a scale | Standard Deviation 15.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 6 months | 82.5 score on a scale | Standard Deviation 15.4 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 12 months | 75.1 score on a scale | Standard Deviation 16.6 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 24 months | 30.0 score on a scale | Standard Deviation 28.3 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 3 months | 73.0 score on a scale | Standard Deviation 16.4 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 12 months | 75.0 score on a scale | Standard Deviation 15.2 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 6 months | 79.3 score on a scale | Standard Deviation 19 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | Baseline | 69.8 score on a scale | Standard Deviation 17.5 |
| ARCR Alone | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 24 months | 87.5 score on a scale | Standard Deviation 3.5 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | Baseline | 65.3 score on a scale | Standard Deviation 23.1 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 6 months | 73.5 score on a scale | Standard Deviation 21.8 |
| Revision Group | EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | 3 months | 80.3 score on a scale | Standard Deviation 20.5 |
Secondary
Mobilization Time in Sling
Mobilization time was the duration, measured in weeks, that participants spent in a sling.
Time frame: up to 3 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Mobilization Time in Sling | 5.5 weeks | Standard Deviation 1.1 |
| ARCR Alone | Mobilization Time in Sling | 5.4 weeks | Standard Deviation 1.3 |
| Revision Group | Mobilization Time in Sling | 5.6 weeks | Standard Deviation 1.1 |
Secondary
MRI Tendon Findings: Infraspinatus Goutallier Classification
Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 2 | 13 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 3 | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 3 | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 0 | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 3 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 4 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 3 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 2 | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 1 | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 0 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 2 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 2 | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 1 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 0 | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 1 | 16 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 0 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 1 | 19 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 0 | 6 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 1 | 13 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 2 | 3 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 3 | 2 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 4 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 0 | 9 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 1 | 19 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 2 | 7 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 3 | 3 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 4 | 2 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 0 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 1 | 6 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 2 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 3 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Grade 4 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 12 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 0 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 1 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 2 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 3 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Goutallier Classification | 24 months | Grade 4 | 1 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 0 | 1 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 1 | 3 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 4 | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 2 | 5 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 3 | 1 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 4 | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 2 | 6 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 0 | 1 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 6 months | Grade 1 | 10 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Goutallier Classification | 3 months | Grade 3 | 1 Participants |
Secondary
MRI Tendon Findings: Infraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type V | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type II | 27 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type I | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type II | 23 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type V | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type I | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type IV | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type V | 13 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type I | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type II | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type IV | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type V | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type I | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type II | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type II | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type II | 20 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type II | 6 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type V | 5 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type V | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type II | 31 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type V | 9 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 12 months | Type V | 3 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 24 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type I | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type I | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type III | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type II | 14 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type V | 4 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type II | 5 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type III | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type IV | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 3 months | Type I | 0 Participants |
| Revision Group | MRI Tendon Findings: Infraspinatus Sugaya Score | 6 months | Type V | 4 Participants |
Secondary
MRI Tendon Findings: Supraspinatus Goutallier Classification
Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 2 | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 3 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 3 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 0 | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 3 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 3 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 2 | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 1 | 10 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 0 | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 2 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 2 | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 1 | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 0 | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 1 | 22 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 0 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 1 | 30 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 4 | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 0 | 3 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 1 | 16 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 2 | 4 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 3 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 4 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 0 | 5 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 1 | 23 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 2 | 7 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 3 | 2 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 4 | 2 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 0 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 1 | 4 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 2 | 2 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 3 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Grade 4 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 12 months | Unable to assess | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 0 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 1 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 2 | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 3 | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Goutallier Classification | 24 months | Grade 4 | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 0 | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 1 | 8 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Unable to assess | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Unable to assess | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 4 | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 2 | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 3 | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 4 | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 2 | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 0 | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 6 months | Grade 1 | 15 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Goutallier Classification | 3 months | Grade 3 | 0 Participants |
Secondary
MRI Tendon Findings: Supraspinatus Sugaya Score
The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. Baseline score not collected as all participants had full-thickness tears. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type III | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type V | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type IV | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type I | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type IV | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type V | 21 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type IV | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type V | 12 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type II | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type I | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type III | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type III | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type II | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type I | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type II | 17 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type I | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type II | 17 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type V | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type II | 15 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type V | 10 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type II | 21 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type IV | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type V | 18 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type II | 3 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type IV | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Type V | 5 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 12 months | Indeterminate | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type I | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type II | 1 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type III | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type IV | 0 Participants |
| ARCR Alone | MRI Tendon Findings: Supraspinatus Sugaya Score | 24 months | Type V | 1 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type I | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type II | 3 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Indeterminate | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Indeterminate | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type V | 7 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type III | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type IV | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type V | 6 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type III | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type I | 0 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 6 months | Type II | 11 Participants |
| Revision Group | MRI Tendon Findings: Supraspinatus Sugaya Score | 3 months | Type IV | 0 Participants |
Secondary
Number of Retears at 3 Months, 12 Months, and 24 Months
Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Time frame: 3 months, 12 months, and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Number of Retears at 3 Months, 12 Months, and 24 Months | 12 months | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Number of Retears at 3 Months, 12 Months, and 24 Months | 3 months | 12 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Number of Retears at 3 Months, 12 Months, and 24 Months | 24 months | 1 Participants |
| ARCR Alone | Number of Retears at 3 Months, 12 Months, and 24 Months | 24 months | 1 Participants |
| ARCR Alone | Number of Retears at 3 Months, 12 Months, and 24 Months | 12 months | 6 Participants |
| ARCR Alone | Number of Retears at 3 Months, 12 Months, and 24 Months | 3 months | 10 Participants |
| Revision Group | Number of Retears at 3 Months, 12 Months, and 24 Months | 3 months | 6 Participants |
Secondary
Opioid Use for More Than 5 Days Post-Surgery
Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
Time frame: Following surgery, up to 14 days
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Opioid Use for More Than 5 Days Post-Surgery | No | 17 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Opioid Use for More Than 5 Days Post-Surgery | Yes | 25 Participants |
| ARCR Alone | Opioid Use for More Than 5 Days Post-Surgery | No | 18 Participants |
| ARCR Alone | Opioid Use for More Than 5 Days Post-Surgery | Yes | 24 Participants |
| Revision Group | Opioid Use for More Than 5 Days Post-Surgery | No | 10 Participants |
| Revision Group | Opioid Use for More Than 5 Days Post-Surgery | Yes | 11 Participants |
Secondary
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Seven participants had out of range scores (i.e., scores were greater than the highest score possible) and were not included for analysis. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Oxford Shoulder Score (OSS) | Baseline | 33.1 score on a scale | Standard Deviation 7.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Oxford Shoulder Score (OSS) | 3 months | 25.1 score on a scale | Standard Deviation 8 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Oxford Shoulder Score (OSS) | 6 months | 18.9 score on a scale | Standard Deviation 6.6 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Oxford Shoulder Score (OSS) | 12 months | 18.8 score on a scale | Standard Deviation 8.5 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Oxford Shoulder Score (OSS) | 24 months | 19.0 score on a scale | Standard Deviation 7.1 |
| ARCR Alone | Oxford Shoulder Score (OSS) | 3 months | 29.4 score on a scale | Standard Deviation 9.7 |
| ARCR Alone | Oxford Shoulder Score (OSS) | 12 months | 17.3 score on a scale | Standard Deviation 7.9 |
| ARCR Alone | Oxford Shoulder Score (OSS) | 6 months | 19.9 score on a scale | Standard Deviation 7.9 |
| ARCR Alone | Oxford Shoulder Score (OSS) | Baseline | 34.0 score on a scale | Standard Deviation 7.5 |
| ARCR Alone | Oxford Shoulder Score (OSS) | 24 months | 15.0 score on a scale | Standard Deviation 4.2 |
| Revision Group | Oxford Shoulder Score (OSS) | Baseline | 29.5 score on a scale | Standard Deviation 7.8 |
| Revision Group | Oxford Shoulder Score (OSS) | 6 months | 18.9 score on a scale | Standard Deviation 7.6 |
| Revision Group | Oxford Shoulder Score (OSS) | 3 months | 23.4 score on a scale | Standard Deviation 9.6 |
Secondary
Pain - Visual Analog Scale (VAS) Score
Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for ARCR+Regeneten subjects at 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Pain - Visual Analog Scale (VAS) Score | 2 weeks | 31.2 score on a scale | Standard Deviation 27.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Pain - Visual Analog Scale (VAS) Score | 6 months | 10.4 score on a scale | Standard Deviation 18 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Pain - Visual Analog Scale (VAS) Score | 6 weeks | 21.5 score on a scale | Standard Deviation 24.3 |
| ARCR Alone | Pain - Visual Analog Scale (VAS) Score | 3 months | 20 score on a scale | — |
| ARCR Alone | Pain - Visual Analog Scale (VAS) Score | 6 weeks | 24 score on a scale | Standard Deviation 26.5 |
| ARCR Alone | Pain - Visual Analog Scale (VAS) Score | 2 weeks | 27.4 score on a scale | Standard Deviation 26.6 |
| ARCR Alone | Pain - Visual Analog Scale (VAS) Score | 6 months | 8 score on a scale | Standard Deviation 17.9 |
| Revision Group | Pain - Visual Analog Scale (VAS) Score | 6 months | 9.2 score on a scale | Standard Deviation 18.6 |
| Revision Group | Pain - Visual Analog Scale (VAS) Score | 2 weeks | 21.6 score on a scale | Standard Deviation 25.8 |
| Revision Group | Pain - Visual Analog Scale (VAS) Score | 6 weeks | 19.3 score on a scale | Standard Deviation 23.8 |
| Revision Group | Pain - Visual Analog Scale (VAS) Score | 3 months | 2 score on a scale | — |
Secondary
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery allow you to perform heavy work or sport activities? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Good | 14 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Fair | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Fair | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Fair | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Fair | 9 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Poor | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Excellent | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Very Good | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Excellent | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Poor | 10 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Poor | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Very Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Excellent | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Good | 10 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Excellent | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Very Good | 10 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Very Good | 3 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Very Good | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Fair | 9 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Poor | 13 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Very Good | 20 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Good | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Fair | 9 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Poor | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Excellent | 5 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Very Good | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Fair | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 12 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Good | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 24 months | Fair | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Excellent | 3 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Good | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Poor | 5 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Poor | 3 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Fair | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Excellent | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Good | 4 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Fair | 3 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 6 months | Very Good | 6 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities | 3 months | Very Good | 5 Participants |
Secondary
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery improve your ability to perform regular activities? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Good | 9 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Fair | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Fair | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Fair | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Fair | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Good | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Excellent | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Very Good | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Excellent | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Poor | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Poor | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Very Good | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Excellent | 13 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Good | 14 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Excellent | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Very Good | 16 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Very Good | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Very Good | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Good | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Fair | 9 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Poor | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Excellent | 8 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Very Good | 21 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Good | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Fair | 3 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Poor | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Excellent | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Good | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Fair | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 12 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Excellent | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Very Good | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Good | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 24 months | Fair | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Excellent | 8 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Good | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Poor | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Poor | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Fair | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Excellent | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Good | 3 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Fair | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 6 months | Very Good | 6 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities | 3 months | Very Good | 8 Participants |
Secondary
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery meet your expectations? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Good | 10 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Fair | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Fair | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Fair | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Fair | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Poor | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Excellent | 11 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Very Good | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Excellent | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Poor | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Very Good | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Excellent | 17 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Good | 9 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Excellent | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Very Good | 11 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Very Good | 8 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Excellent | 8 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Very Good | 9 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Good | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Fair | 3 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Poor | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Excellent | 17 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Very Good | 13 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Good | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Fair | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Poor | 3 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Excellent | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Good | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Fair | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 12 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Good | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 24 months | Fair | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Excellent | 7 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Good | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Poor | 4 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Poor | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Fair | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Excellent | 8 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Good | 3 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Fair | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 6 months | Very Good | 5 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations | 3 months | Very Good | 3 Participants |
Secondary
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, How well did the surgery relieve the pain? with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Poor | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Good | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Fair | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Fair | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Fair | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Fair | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Poor | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Excellent | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Very Good | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Excellent | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Good | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Poor | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Poor | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Very Good | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Excellent | 15 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Good | 11 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Excellent | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Very Good | 17 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Very Good | 11 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Excellent | 9 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Very Good | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Good | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Fair | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Poor | 3 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Excellent | 18 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Very Good | 13 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Good | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Fair | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Poor | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Excellent | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Fair | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 12 months | Poor | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Excellent | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Very Good | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Good | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 24 months | Fair | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Excellent | 10 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Good | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Poor | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Poor | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Fair | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Excellent | 5 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Good | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Fair | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 6 months | Very Good | 6 Participants |
| Revision Group | Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain | 3 months | Very Good | 5 Participants |
Secondary
Patient Satisfaction Questionnaire: Medical Care
The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question How satisfied are you with your medical care?. Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Medical Care | Baseline | 88.6 score on a scale | Standard Deviation 19.8 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Medical Care | 3 months | 88.8 score on a scale | Standard Deviation 13.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Medical Care | 6 months | 89.7 score on a scale | Standard Deviation 19.9 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Medical Care | 12 months | 91.5 score on a scale | Standard Deviation 11.3 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Medical Care | 24 months | 90 score on a scale | — |
| ARCR Alone | Patient Satisfaction Questionnaire: Medical Care | 3 months | 93.1 score on a scale | Standard Deviation 13.3 |
| ARCR Alone | Patient Satisfaction Questionnaire: Medical Care | 12 months | 94.4 score on a scale | Standard Deviation 9 |
| ARCR Alone | Patient Satisfaction Questionnaire: Medical Care | 6 months | 93.6 score on a scale | Standard Deviation 16.6 |
| ARCR Alone | Patient Satisfaction Questionnaire: Medical Care | Baseline | 94.3 score on a scale | Standard Deviation 8.3 |
| ARCR Alone | Patient Satisfaction Questionnaire: Medical Care | 24 months | 90 score on a scale | — |
| Revision Group | Patient Satisfaction Questionnaire: Medical Care | Baseline | 89 score on a scale | Standard Deviation 19.2 |
| Revision Group | Patient Satisfaction Questionnaire: Medical Care | 6 months | 90.8 score on a scale | Standard Deviation 23.4 |
| Revision Group | Patient Satisfaction Questionnaire: Medical Care | 3 months | 89.2 score on a scale | Standard Deviation 27.3 |
Secondary
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, Would you repeat the operation again if needed on another joint? with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Possibly Not | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Definitely Not | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Possibly Not | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Probably Yes | 11 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Possibly Not | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Not | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Possibly Not | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Probably Yes | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Definitely Yes | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Not | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Yes | 20 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Probably Yes | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Yes | 22 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Definitely Not | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Definitely Yes | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Probably Yes | 14 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Definitely Not | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Yes | 18 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Probably Yes | 7 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Possibly Not | 0 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Not | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Yes | 25 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Probably Yes | 12 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Possibly Not | 4 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Not | 2 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Definitely Yes | 6 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Probably Yes | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Possibly Not | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 12 months | Definitely Not | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Definitely Yes | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Probably Yes | 1 Participants |
| ARCR Alone | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 24 months | Possibly Not | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Yes | 10 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Yes | 11 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Definitely Not | 1 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Definitely Not | 0 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Possibly Not | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Probably Yes | 2 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 6 months | Probably Yes | 7 Participants |
| Revision Group | Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint | 3 months | Possibly Not | 1 Participants |
Secondary
Return to Work Questionnaire
Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Each group with 0 participants analyzed for Since last follow-up visit did you take additional time off... question at 2 weeks, 6 weeks, 3 months, \& 6 months indicated no responses were provided (i.e., data not collected).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | Yes | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Returned to work? | No | 18 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Returned to work? | Yes | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Returned to work? | No | 15 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Returned to work? | Yes | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Returned to work? | No | 12 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Returned to work? | Yes | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Returned to work? | No | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Returned to work? | Yes | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | No | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | Yes | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | Yes | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | Yes | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | Yes | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | No | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | Yes | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | Yes | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | Yes | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | No | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 4 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | No | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | Yes | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | No | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 3 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | Yes | 10 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | No | 3 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? | Yes | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | Yes | 5 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | No | 0 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | Yes | 3 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | No | 0 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | Yes | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | No | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? | No | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | Yes | 12 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Returned to work? | Yes | 5 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 1 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Returned to work? | No | 20 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | No | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Returned to work? | Yes | 3 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Returned to work? | No | 16 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Returned to work? | Yes | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 3 months: Returned to work? | No | 11 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Returned to work? | Yes | 14 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Returned to work? | No | 9 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 5 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | Yes | 2 Participants |
| ARCR Alone | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | No | 3 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 13 Participants |
| ARCR Alone | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | Yes | 1 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | Yes | 2 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 3 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | Yes | 2 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Have you been able to return to the job you did before your surgery? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Returned to work? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | Yes | 1 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 2 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Returned to work? | Yes | 3 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Have you been able to return to the job you did before your surgery? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | No | 2 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | Yes | 3 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Since returning to work, any time off due to shoulder pain or weakness? | No | 3 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Returned to work? | No | 8 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Have you been able to return to the job you did before your surgery? | No | 0 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Returned to work? | Yes | 3 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | Yes | 2 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Returned to work? | Yes | 3 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Did you feel ready to go back to work physically? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Did you feel ready to go back to work physically? | No | 1 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 0 Participants |
| Revision Group | Return to Work Questionnaire | 2 weeks: Have you been able to return to the job you did before your surgery? | Yes | 1 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | Yes | 3 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Since last follow-up visit did you take additional time off due to shoulder pain/weakness? | Yes | 0 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Returned to work? | No | 5 Participants |
| Revision Group | Return to Work Questionnaire | 6 weeks: Did you feel ready to go back to work physically? | No | 0 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Since returning to work, any time off due to shoulder pain or weakness? | Yes | 1 Participants |
| Revision Group | Return to Work Questionnaire | 6 months: Returned to work? | No | 3 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | Yes | 2 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Since returning to work, any time off due to shoulder pain or weakness? | No | 2 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Returned to work? | Yes | 2 Participants |
| Revision Group | Return to Work Questionnaire | 3 months: Did you feel ready to go back to work physically? | No | 0 Participants |
Secondary
Return to Work Questionnaire: Duration Away From Work (Days)
Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the Returned to work? question were asked to provide the number of days taken away from work
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. Data not collected for 2 subjects who responded yes at 6 months in ARCR alone group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Duration Away From Work (Days) | 2 weeks | 6.7 days | Standard Deviation 3 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Duration Away From Work (Days) | 6 weeks | 19 days | — |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Duration Away From Work (Days) | 3 months | 68.3 days | Standard Deviation 20.8 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Duration Away From Work (Days) | 6 months | 74.5 days | Standard Deviation 69.9 |
| ARCR Alone | Return to Work Questionnaire: Duration Away From Work (Days) | 6 months | 80.3 days | Standard Deviation 63.8 |
| ARCR Alone | Return to Work Questionnaire: Duration Away From Work (Days) | 2 weeks | 7.2 days | Standard Deviation 4.4 |
| ARCR Alone | Return to Work Questionnaire: Duration Away From Work (Days) | 3 months | 64.5 days | Standard Deviation 16.3 |
| ARCR Alone | Return to Work Questionnaire: Duration Away From Work (Days) | 6 weeks | 23 days | Standard Deviation 4.6 |
| Revision Group | Return to Work Questionnaire: Duration Away From Work (Days) | 6 months | 75 days | Standard Deviation 18.7 |
| Revision Group | Return to Work Questionnaire: Duration Away From Work (Days) | 6 weeks | 30.3 days | Standard Deviation 15.9 |
| Revision Group | Return to Work Questionnaire: Duration Away From Work (Days) | 3 months | 52 days | Standard Deviation 11.3 |
| Revision Group | Return to Work Questionnaire: Duration Away From Work (Days) | 2 weeks | 6.7 days | Standard Deviation 5.1 |
Secondary
Return to Work Questionnaire: Reason Couldn't Return to Activities
The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the Have you been able to return to the job you did before your surgery? question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Physical capability | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Other | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Motivation | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 months | Other | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Physical capability | 3 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Other | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Physical capability | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Safety | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Other | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Physical capability | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Other | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 months | Physical capability | 2 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 months | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 months | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Other | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Physical capability | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Physical capability | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 2 weeks | Physical capability | 2 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 3 months | Other | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason Couldn't Return to Activities | 6 weeks | Other | 0 Participants |
Secondary
Return to Work Questionnaire: Reason for Not Getting Back to Work
The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the Returned to work? question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Motivation | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Safety | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Physical capability | 12 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Safety | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Motivation | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Safety | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Physical capability | 7 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Other | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Motivation | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Other | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Physical capability | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Other | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Motivation | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Other | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Physical capability | 11 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Safety | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Other | 6 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Physical capability | 13 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Safety | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Physical capability | 12 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Safety | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Motivation | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Other | 2 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Physical capability | 8 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Other | 2 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Physical capability | 3 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Safety | 1 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Motivation | 0 Participants |
| ARCR Alone | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Other | 4 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Other | 2 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Other | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Other | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Physical capability | 2 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Safety | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Other | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Motivation | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 months | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 3 months | Physical capability | 1 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Safety | 0 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 6 weeks | Physical capability | 4 Participants |
| Revision Group | Return to Work Questionnaire: Reason for Not Getting Back to Work | 2 weeks | Physical capability | 5 Participants |
Secondary
Return to Work Questionnaire: Time Off
Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the Since returning to work, any time off due to shoulder pain or weakness? question were asked to provide how long they have taken off in days.
Time frame: 2 weeks, 6 weeks, 3 months, 6 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ARCR Alone | Return to Work Questionnaire: Time Off | 6 months | 8 days |
| Revision Group | Return to Work Questionnaire: Time Off | 6 months | 2 days |
| Unknown | Return to Work Questionnaire: Time Off | 2 weeks | — days |
| Unknown | Return to Work Questionnaire: Time Off | 6 weeks | — days |
| Unknown | Return to Work Questionnaire: Time Off | 3 months | — days |
Secondary
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Unable to Assess | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Longitudinal | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Massive | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Massive | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Massive | 18 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Massive | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Longitudinal | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Unable to Assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Intact (i.e., no re-tear) | 18 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Crescent | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Intact (i.e., no re-tear) | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Longitudinal | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Unable to Assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Unable to Assess | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Crescent | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Intact (i.e., no re-tear) | 16 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Longitudinal | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Intact (i.e., no re-tear) | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Crescent | 3 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Crescent | 1 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Unable to Assess | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Intact (i.e., no re-tear) | 14 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Crescent | 2 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Longitudinal | 1 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Massive | 8 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Unable to Assess | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Intact (i.e., no re-tear) | 21 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Crescent | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Longitudinal | 4 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Massive | 14 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Unable to Assess | 1 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Intact (i.e., no re-tear) | 3 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Crescent | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Longitudinal | 2 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Massive | 4 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 12 months | Unable to Assess | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Intact (i.e., no re-tear) | 1 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Crescent | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Longitudinal | 0 Participants |
| ARCR Alone | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 24 months | Massive | 1 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Intact (i.e., no re-tear) | 10 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Longitudinal | 2 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Unable to Assess | 0 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Unable to Assess | 1 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Massive | 3 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Intact (i.e., no re-tear) | 3 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Longitudinal | 4 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Massive | 4 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 6 months | Crescent | 1 Participants |
| Revision Group | Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months | 3 months | Crescent | 0 Participants |
Secondary
Shape of Retear: Operative Visit
Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine
Time frame: Day 0
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | Crescent | 12 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | L Shape | 2 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | Reverse L | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | U Shape | 6 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | Massive/Contracted | 5 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Shape of Retear: Operative Visit | Unable to Determine | 0 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | Unable to Determine | 0 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | Crescent | 8 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | U Shape | 4 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | Massive/Contracted | 3 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | L Shape | 7 Participants |
| ARCR Alone | Shape of Retear: Operative Visit | Reverse L | 2 Participants |
| Revision Group | Shape of Retear: Operative Visit | L Shape | 0 Participants |
| Revision Group | Shape of Retear: Operative Visit | Reverse L | 2 Participants |
| Revision Group | Shape of Retear: Operative Visit | Unable to Determine | 0 Participants |
| Revision Group | Shape of Retear: Operative Visit | U Shape | 3 Participants |
| Revision Group | Shape of Retear: Operative Visit | Crescent | 7 Participants |
| Revision Group | Shape of Retear: Operative Visit | Massive/Contracted | 1 Participants |
Secondary
Size of Retear: Anteroposterior (AP) Length
Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Anteroposterior (AP) Length | 6 months | 27.4 millimeters (mm) | Standard Deviation 12.1 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Anteroposterior (AP) Length | Day 0 | 32.1 millimeters (mm) | Standard Deviation 7.2 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Anteroposterior (AP) Length | 3 months | 29.9 millimeters (mm) | Standard Deviation 12.5 |
| ARCR Alone | Size of Retear: Anteroposterior (AP) Length | 3 months | 30.7 millimeters (mm) | Standard Deviation 9.8 |
| ARCR Alone | Size of Retear: Anteroposterior (AP) Length | 6 months | 29.9 millimeters (mm) | Standard Deviation 10.9 |
| ARCR Alone | Size of Retear: Anteroposterior (AP) Length | Day 0 | 31.8 millimeters (mm) | Standard Deviation 7.4 |
| Revision Group | Size of Retear: Anteroposterior (AP) Length | Day 0 | 30 millimeters (mm) | Standard Deviation 8.2 |
| Revision Group | Size of Retear: Anteroposterior (AP) Length | 6 months | 26.8 millimeters (mm) | Standard Deviation 14.3 |
| Revision Group | Size of Retear: Anteroposterior (AP) Length | 3 months | 28.1 millimeters (mm) | Standard Deviation 14 |
Secondary
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 3 months | 1173.2 millimeters squared (mm^2) | Standard Deviation 698.5 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | Day 0 | 1041.7 millimeters squared (mm^2) | Standard Deviation 482.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 6 months | 1000.6 millimeters squared (mm^2) | Standard Deviation 699.2 |
| ARCR Alone | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 3 months | 1099.6 millimeters squared (mm^2) | Standard Deviation 554.1 |
| ARCR Alone | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | Day 0 | 1004 millimeters squared (mm^2) | Standard Deviation 448.5 |
| ARCR Alone | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 6 months | 1203.0 millimeters squared (mm^2) | Standard Deviation 624.3 |
| Revision Group | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | Day 0 | 877.1 millimeters squared (mm^2) | Standard Deviation 218.3 |
| Revision Group | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 6 months | 1159.6 millimeters squared (mm^2) | Standard Deviation 1022.3 |
| Revision Group | Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML]) | 3 months | 1158.2 millimeters squared (mm^2) | Standard Deviation 790.8 |
Secondary
Size of Retear: Mediolateral (ML) Length
Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
Time frame: Day 0, 3 months and 6 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Mediolateral (ML) Length | 3 months | 36.9 millimeters (mm) | Standard Deviation 8.9 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Mediolateral (ML) Length | Day 0 | 31.7 millimeters (mm) | Standard Deviation 8.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Size of Retear: Mediolateral (ML) Length | 6 months | 32.1 millimeters (mm) | Standard Deviation 12.8 |
| ARCR Alone | Size of Retear: Mediolateral (ML) Length | 3 months | 33.6 millimeters (mm) | Standard Deviation 11.4 |
| ARCR Alone | Size of Retear: Mediolateral (ML) Length | Day 0 | 31.7 millimeters (mm) | Standard Deviation 11.4 |
| ARCR Alone | Size of Retear: Mediolateral (ML) Length | 6 months | 37.1 millimeters (mm) | Standard Deviation 13.2 |
| Revision Group | Size of Retear: Mediolateral (ML) Length | Day 0 | 29.4 millimeters (mm) | Standard Deviation 1.5 |
| Revision Group | Size of Retear: Mediolateral (ML) Length | 6 months | 38.1 millimeters (mm) | Standard Deviation 16.4 |
| Revision Group | Size of Retear: Mediolateral (ML) Length | 3 months | 37.6 millimeters (mm) | Standard Deviation 11.1 |
Secondary
Sling Type
The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing
Time frame: up to 3 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Shoulder Immobilizer | 20 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | External Rotation Sling | 0 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Abduction Sling | 8 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Standard Sling | 13 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Missing | 1 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Other | 4 Participants |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Sling Type | Sling and Swathe | 0 Participants |
| ARCR Alone | Sling Type | Abduction Sling | 4 Participants |
| ARCR Alone | Sling Type | Standard Sling | 17 Participants |
| ARCR Alone | Sling Type | Shoulder Immobilizer | 16 Participants |
| ARCR Alone | Sling Type | Sling and Swathe | 0 Participants |
| ARCR Alone | Sling Type | External Rotation Sling | 3 Participants |
| ARCR Alone | Sling Type | Other | 4 Participants |
| ARCR Alone | Sling Type | Missing | 4 Participants |
| Revision Group | Sling Type | External Rotation Sling | 0 Participants |
| Revision Group | Sling Type | Shoulder Immobilizer | 6 Participants |
| Revision Group | Sling Type | Missing | 2 Participants |
| Revision Group | Sling Type | Other | 7 Participants |
| Revision Group | Sling Type | Abduction Sling | 4 Participants |
| Revision Group | Sling Type | Sling and Swathe | 0 Participants |
| Revision Group | Sling Type | Standard Sling | 5 Participants |
Secondary
Subjective Shoulder Value (SSV)
The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Subjective Shoulder Value (SSV) | Baseline | 38.3 score on a scale | Standard Deviation 21.6 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Subjective Shoulder Value (SSV) | 12 months | 80.0 score on a scale | Standard Deviation 14.9 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Subjective Shoulder Value (SSV) | 6 months | 74.1 score on a scale | Standard Deviation 17.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Subjective Shoulder Value (SSV) | 24 months | 77.5 score on a scale | Standard Deviation 24.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Subjective Shoulder Value (SSV) | 3 months | 60.1 score on a scale | Standard Deviation 21 |
| ARCR Alone | Subjective Shoulder Value (SSV) | 24 months | 91.5 score on a scale | Standard Deviation 9.2 |
| ARCR Alone | Subjective Shoulder Value (SSV) | Baseline | 38.1 score on a scale | Standard Deviation 24.6 |
| ARCR Alone | Subjective Shoulder Value (SSV) | 3 months | 57.1 score on a scale | Standard Deviation 20.8 |
| ARCR Alone | Subjective Shoulder Value (SSV) | 6 months | 77.3 score on a scale | Standard Deviation 20.6 |
| ARCR Alone | Subjective Shoulder Value (SSV) | 12 months | 88.9 score on a scale | Standard Deviation 10.2 |
| Revision Group | Subjective Shoulder Value (SSV) | 3 months | 72.5 score on a scale | Standard Deviation 16.8 |
| Revision Group | Subjective Shoulder Value (SSV) | Baseline | 47.1 score on a scale | Standard Deviation 22.7 |
| Revision Group | Subjective Shoulder Value (SSV) | 6 months | 76.3 score on a scale | Standard Deviation 21.4 |
Secondary
Total Operative Time
Total operative time in minutes.
Time frame: Intraoperative
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Operative Time | 176.2 minutes | Standard Deviation 60.9 |
| ARCR Alone | Total Operative Time | 138.8 minutes | Standard Deviation 42.7 |
| Revision Group | Total Operative Time | 172.8 minutes | Standard Deviation 47.7 |
Secondary
Total Tendon Length
Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Length | 6 months | 34.7 millimeters (mm) | Standard Deviation 9.6 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Length | 3 months | 36.4 millimeters (mm) | Standard Deviation 9.3 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Length | 12 months | 33.6 millimeters (mm) | Standard Deviation 10.3 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Length | 24 months | 49.1 millimeters (mm) | — |
| ARCR Alone | Total Tendon Length | 24 months | 19.9 millimeters (mm) | Standard Deviation 13.6 |
| ARCR Alone | Total Tendon Length | 6 months | 33.9 millimeters (mm) | Standard Deviation 10.4 |
| ARCR Alone | Total Tendon Length | 3 months | 32.6 millimeters (mm) | Standard Deviation 11.3 |
| ARCR Alone | Total Tendon Length | 12 months | 29.6 millimeters (mm) | Standard Deviation 13 |
| Revision Group | Total Tendon Length | 3 months | 40.2 millimeters (mm) | Standard Deviation 1.3 |
| Revision Group | Total Tendon Length | 6 months | 38.2 millimeters (mm) | Standard Deviation 4 |
Secondary
Total Tendon Thickness
Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
Time frame: 3 months, 6 months, 12 months and 24 months
Population: The safety analysis set (SAF) included participants that received the study device with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject. No (0) ARCR alone subjects tendon thickness at 24 months could be reported as no data was collected because relevant images were missing, not available, or relevant anatomy not visible in field of view.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Thickness | 3 months | 5.6 millimeters (mm) | Standard Deviation 1.4 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Thickness | 6 months | 5.9 millimeters (mm) | Standard Deviation 1.2 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Thickness | 12 months | 4.9 millimeters (mm) | Standard Deviation 1 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Total Tendon Thickness | 24 months | 5 millimeters (mm) | Standard Deviation 0.3 |
| ARCR Alone | Total Tendon Thickness | 6 months | 5.5 millimeters (mm) | Standard Deviation 1 |
| ARCR Alone | Total Tendon Thickness | 3 months | 5.4 millimeters (mm) | Standard Deviation 1.1 |
| ARCR Alone | Total Tendon Thickness | 12 months | 5.5 millimeters (mm) | Standard Deviation 0.6 |
| Revision Group | Total Tendon Thickness | 6 months | 5.7 millimeters (mm) | Standard Deviation 1.1 |
| Revision Group | Total Tendon Thickness | 3 months | 6.2 millimeters (mm) | Standard Deviation 1.5 |
Secondary
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
Time frame: Baseline, 3 months, 6 months, 12 months and 24 months
Population: The full analysis set (FAS) followed the Intent-to-Treat principle that included participants enrolled into the study that attended at least one post-surgery assessment with data collected for the time frame and outcome indicated. No (0) Revision subjects completed the 12 or 24 month visit due to the early termination of the study or withdrawal of subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | Baseline | 1271.3 score on a scale | Standard Deviation 366.6 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 3 months | 860.7 score on a scale | Standard Deviation 350.1 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 6 months | 533.6 score on a scale | Standard Deviation 429.5 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 12 months | 432.8 score on a scale | Standard Deviation 453.7 |
| ARCR Augmented With REGENETEN™ Bioinductive Implant | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 24 months | 281.5 score on a scale | Standard Deviation 252.4 |
| ARCR Alone | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 3 months | 936.7 score on a scale | Standard Deviation 472.4 |
| ARCR Alone | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 12 months | 405.6 score on a scale | Standard Deviation 596.5 |
| ARCR Alone | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 6 months | 540.1 score on a scale | Standard Deviation 475.1 |
| ARCR Alone | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | Baseline | 1307.5 score on a scale | Standard Deviation 398.7 |
| ARCR Alone | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 24 months | 62.5 score on a scale | Standard Deviation 81.3 |
| Revision Group | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | Baseline | 1194.0 score on a scale | Standard Deviation 427.6 |
| Revision Group | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 6 months | 548.8 score on a scale | Standard Deviation 493.4 |
| Revision Group | Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index | 3 months | 703.9 score on a scale | Standard Deviation 365.1 |