Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Conditions
Brief summary
The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.
Interventions
DEVICEBioinductive implant
DEVICESurgical repair
Surgical repair with commercially-available sutures/suture anchors.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects enrolled in the study MUST meet all of the following criteria: 1. At least 21 years of age 2. Rotator cuff tear requiring surgery that meets either criterion A or B: A. Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair 3. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections 4. MRI of the shoulder within 60 days prior to the study procedure 5. Willing to comply with the prescribed post-operative rehabilitation program 6. Willing to be available for each protocol-required follow-up examination 7. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures 8. Ability to read, understand, and complete subject-reported outcomes in English
Exclusion criteria
Subjects enrolled in the study MUST NOT meet any of the following criteria: 1. Massive rotator cuff tears (≥ 5 cm) 2. Acute rotator cuff tears less than 12 months from injury 3. Previous rotator cuff surgery on the index shoulder 4. Instability of the index shoulder 5. Chondromalacia of index shoulder ≥ Grade 3 6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2 7. Calcification of the index shoulder rotator cuff 8. Genetic collagen disease 9. History of insulin dependent diabetes 10. History of auto-immune or immunodeficiency disorders 11. History of chronic inflammatory disorders 12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks 13. History of heavy smoking (\> 1 pack per day) within last 6 months 14. Hypersensitivity to bovine-derived materials 15. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study 16. Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder 17. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study 18. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation 19. History of cognitive or mental health status that interferes with study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tendon Thickness | Pre-operatively (baseline) to 3 month, 1 year, and 2 year | The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large). |
| Integration of Induced Tissue With Underlying Tendon | 3 months, 1 year, and 2 years | Partial-thickness tears were classified as Intermediate (3-6 mm) or High (\> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? |
| Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 months, 1 year, and 2 years | For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: * 0 to \<25% * 25% to \<50% * 50% to \< 75% * 75% to \< 100% * 100% |
| Number of Participants With a Re-Tear | 3 months, 1 year, and 2 years | Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery: Sling Time | Post-operatively to study completion, approximately 2 years | Cumulative number of days index shoulder was in a sling. |
| Recovery: Rehabilitation Time | Post-operatively to study completion, approximately 2 years | Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder. |
| Procedure Parameters: Device Implant Time | Intraoperative | Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple. |
| Recovery: Return to Normal Daily Activities | Post-operatively to study completion, approximately 2 years | Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity. |
| Participant Satisfaction | 3 months, 1 year, and 2 years | Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following: * Strongly Disagree * Disagree * Neither Agree or Disagree * Agree * Strongly Agree Strongly Disagree indicated the lowest level of satisfaction and Strongly Agree indicated the greatest level of satisfaction. |
| Recovery: Return to Work | Post-operatively to study completion, approximately 2 years | Cumulative number of days between discharge and return to work (employed subjects only). |
| Procedure Parameters: Procedure Technical Success | Intraoperative | Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful). |
| American Shoulder and Elbow Society (ASES) Score | Baseline, 3 month, 1 year, and 2 years | The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows: 1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better). 2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better). 3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better). Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years). |
| Constant-Murley Shoulder (CMS) Score | Baseline, 3 months, 1 year, and 2 years | The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years). |
Countries
United States
Participant flow
Recruitment details
Recruitment started on 20 August 2014 and the study concluded on 24 November 2020 across 15 participating medical clinics in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Partial-Thickness Tear Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant. | 33 |
| Full Thickness Tear Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.
Surgical repair: Surgical repair with commercially-available sutures/suture anchors. | 115 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 9 |
| Overall Study | Participant withdrew consent | 0 | 1 |
| Overall Study | Subject moved out of town and unable to make it back to study | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Partial-Thickness Tear | Full Thickness Tear |
|---|---|---|---|
| Affected Shoulder Left | 53 Participants | 16 Participants | 37 Participants |
| Affected Shoulder Right | 95 Participants | 17 Participants | 78 Participants |
| Age, Continuous | 59.10 years STANDARD_DEVIATION 8.83 | 54.60 years STANDARD_DEVIATION 10.13 | 60.40 years STANDARD_DEVIATION 8.01 |
| Employment Status Currently employed (working for pay) | 105 Participants | 22 Participants | 83 Participants |
| Employment Status Currently unemployed (not working for pay) | 43 Participants | 11 Participants | 32 Participants |
| Hand Dominance Left | 16 Participants | 4 Participants | 12 Participants |
| Hand Dominance Right | 132 Participants | 29 Participants | 103 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 9 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 133 Participants | 33 Participants | 100 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 5 Participants | 0 Participants | 5 Participants |
| Region of Enrollment United States | 148 participants | 33 participants | 115 participants |
| Sex: Female, Male Female | 53 Participants | 14 Participants | 39 Participants |
| Sex: Female, Male Male | 95 Participants | 19 Participants | 76 Participants |
| Smoking Habit Current Smoker | 4 Participants | 1 Participants | 3 Participants |
| Smoking Habit Former Smoker | 43 Participants | 12 Participants | 31 Participants |
| Smoking Habit Never Smoked | 101 Participants | 20 Participants | 81 Participants |
| Tear Size: Full Thickness ONLY Large (3-5 cm) | 49 Participants | 0 Participants | 49 Participants |
| Tear Size: Full Thickness ONLY Massive (> 5 cm) | 0 Participants | 0 Participants | 0 Participants |
| Tear Size: Full Thickness ONLY Medium (1-3 cm) | 66 Participants | 0 Participants | 66 Participants |
| Tear Size: Full Thickness ONLY Small (< 1 cm) | 0 Participants | 0 Participants | 0 Participants |
| Tear Size: Partial-Thickness ONLY Grade 1: Low (< 3 mm) | 0 Participants | 0 Participants | 0 Participants |
| Tear Size: Partial-Thickness ONLY Grade 2: Intermediate (3-6 mm) | 12 Participants | 12 Participants | 0 Participants |
| Tear Size: Partial-Thickness ONLY Grade 3: High (> 6 mm) | 21 Participants | 21 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 115 |
| other Total, other adverse events | 7 / 33 | 10 / 115 |
| serious Total, serious adverse events | 1 / 33 | 12 / 115 |
Outcome results
Primary
Change in Tendon Thickness
The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).
Time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
Population: Participants with partial-thickness or full thickness tears that provided data at the specified time frames.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 3 Month | 1.7 millimeters | Standard Deviation 1.5 |
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 1 Year | 1.4 millimeters | Standard Deviation 1.3 |
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 2 Year | 1.2 millimeters | Standard Deviation 1.3 |
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 1 Year | -0.3 millimeters | Standard Deviation 0.4 |
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 2 Year | -0.3 millimeters | Standard Deviation 0.4 |
| Intermediate Partial-Thickness Tear | Change in Tendon Thickness | Change from 1 Year to 2 Year | -0.1 millimeters | Standard Deviation 0.3 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from 1 Year to 2 Year | -0.4 millimeters | Standard Deviation 0.9 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 1 Year | -0.4 millimeters | Standard Deviation 0.6 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 3 Month | 2.6 millimeters | Standard Deviation 19 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 2 Year | 1.8 millimeters | Standard Deviation 2.2 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from Baseline to 1 Year | 2.3 millimeters | Standard Deviation 1.8 |
| High Partial-Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 2 Year | -0.8 millimeters | Standard Deviation 1.2 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 1 Year | 0.6 millimeters | Standard Deviation 1.9 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 2 Year | 0.7 millimeters | Standard Deviation 2 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 1 Year | -0.5 millimeters | Standard Deviation 1.3 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from 1 Year to 2 Year | -0.2 millimeters | Standard Deviation 0.9 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 2 Year | -0.6 millimeters | Standard Deviation 1.6 |
| Medium Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 3 Month | 1.2 millimeters | Standard Deviation 1.7 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 2 Year | -0.6 millimeters | Standard Deviation 1.8 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from 1 Year to 2 Year | -0.1 millimeters | Standard Deviation 1.1 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 1 Year | 0.7 millimeters | Standard Deviation 2.2 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from 3 Months to 1 Year | -0.4 millimeters | Standard Deviation 1.9 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 3 Month | 1.2 millimeters | Standard Deviation 2.2 |
| Large Full Thickness Tear | Change in Tendon Thickness | Change from Baseline to 2 Year | 0.7 millimeters | Standard Deviation 2.3 |
Primary
Fill-In of Partial Thickness Tears and Underlying Tendon Quality
For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: * 0 to \<25% * 25% to \<50% * 50% to \< 75% * 75% to \< 100% * 100%
Time frame: 3 months, 1 year, and 2 years
Population: Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 100% | 2 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 75% to < 100% | 7 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 25% to < 50% | 0 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 100% | 2 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 0 to < 25% | 0 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 0 to < 25% | 0 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 75% to < 100% | 8 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 25% to < 50% | 1 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 25% to < 50% | 1 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 50% to < 75% | 2 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 50% to < 75% | 1 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 75% to < 100% | 8 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 50% to < 75% | 2 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 100% | 0 Participants |
| Intermediate Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 0 to < 25% | 1 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 100% | 3 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 0 to < 25% | 0 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 25% to < 50% | 2 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 50% to < 75% | 3 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 75% to < 100% | 11 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 3 Months | 100% | 4 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 0 to < 25% | 1 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 25% to < 50% | 0 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 50% to < 75% | 3 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 75% to < 100% | 10 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 1 Year | 100% | 6 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 0 to < 25% | 1 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 25% to < 50% | 2 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 50% to < 75% | 2 Participants |
| High Partial-Thickness Tear | Fill-In of Partial Thickness Tears and Underlying Tendon Quality | 2 Years | 75% to < 100% | 11 Participants |
Primary
Integration of Induced Tissue With Underlying Tendon
Partial-thickness tears were classified as Intermediate (3-6 mm) or High (\> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?
Time frame: 3 months, 1 year, and 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | No | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 8 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 11 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | No | 1 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 1 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 5 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Yes | 10 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 1 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Yes | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 10 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 1 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Yes | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 7 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 6 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 11 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 2 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 2 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 3 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | No | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 9 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 4 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 8 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 8 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 1 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 4 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | No | 11 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 3 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | No | 12 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 4 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 7 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Intermediate Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | No | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 18 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 3 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 11 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 9 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 7 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 13 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 12 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 9 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 6 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 15 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 4 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 16 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Yes | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Yes | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Yes | 18 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | No | 2 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | No | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | No | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | No | 20 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 21 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 20 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 2 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 19 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 9 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 9 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 3 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 10 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 8 Participants |
| High Partial-Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 2 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | No | 66 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 13 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | No | 60 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 14 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 1 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 60 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 60 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 20 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Unable to determine | 2 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 49 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 2 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 43 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 5 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 39 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Yes | 65 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | No | 65 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 13 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 51 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 26 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Unable to determine | 1 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 66 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Yes | 66 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 60 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 8 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | No | 65 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 52 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 8 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 11 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 3 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Yes | 57 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 43 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | No | 5 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 2 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 57 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Medium Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 3 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | No | 45 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 10 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 38 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the new tissue resemble normal tendon tissue? | Unable to determine | 2 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 23 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | No | 43 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 29 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the new tissue resemble normal tendon tissue? | Unable to determine | 5 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 18 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | No | 37 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 24 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Does the new tissue resemble normal tendon tissue? | Unable to determine | 3 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 19 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 38 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 7 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 48 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 2 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | No | 48 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Unable to determine | 43 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | No | 40 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | No | 5 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 22 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Yes | 48 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 32 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | Yes | 21 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Yes | 48 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? | Yes | 2 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Yes | 8 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Was there evidence of bursitis in the shoulder? | Unable to determine | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | No | 24 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | Yes | 40 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | Unable to determine | 38 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 2 Years: Was there evidence of bursitis in the shoulder? | No | 0 Participants |
| Large Full Thickness Tear | Integration of Induced Tissue With Underlying Tendon | 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? | No | 0 Participants |
Primary
Number of Participants With a Re-Tear
Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.
Time frame: 3 months, 1 year, and 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Number of Participants With a Re-Tear | 3 Months | 0 Participants |
| Intermediate Partial-Thickness Tear | Number of Participants With a Re-Tear | 2 Years | 0 Participants |
| Intermediate Partial-Thickness Tear | Number of Participants With a Re-Tear | 1 Year | 0 Participants |
| High Partial-Thickness Tear | Number of Participants With a Re-Tear | 3 Months | 1 Participants |
| High Partial-Thickness Tear | Number of Participants With a Re-Tear | 2 Years | 1 Participants |
| High Partial-Thickness Tear | Number of Participants With a Re-Tear | 1 Year | 1 Participants |
| Medium Full Thickness Tear | Number of Participants With a Re-Tear | 1 Year | 7 Participants |
| Medium Full Thickness Tear | Number of Participants With a Re-Tear | 3 Months | 3 Participants |
| Medium Full Thickness Tear | Number of Participants With a Re-Tear | 2 Years | 7 Participants |
| Large Full Thickness Tear | Number of Participants With a Re-Tear | 3 Months | 10 Participants |
| Large Full Thickness Tear | Number of Participants With a Re-Tear | 2 Years | 14 Participants |
| Large Full Thickness Tear | Number of Participants With a Re-Tear | 1 Year | 12 Participants |
Secondary
American Shoulder and Elbow Society (ASES) Score
The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows: 1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better). 2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better). 3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better). Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).
Time frame: Baseline, 3 month, 1 year, and 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Score | 70.2 score on a scale | Standard Deviation 18.6 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Score | 95.3 score on a scale | Standard Deviation 5.8 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Function Score | 27.7 score on a scale | Standard Deviation 3.4 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: ASES Pain Score | 4.6 score on a scale | Standard Deviation 1.9 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Score | 52.5 score on a scale | Standard Deviation 13.6 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: ASES Pain Score | 1.2 score on a scale | Standard Deviation 1.6 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: ASES Pain Score | 0.2 score on a scale | Standard Deviation 0.4 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: ASES Pain Score | 1.8 score on a scale | Standard Deviation 1.9 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Score | 89.2 score on a scale | Standard Deviation 14.4 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Function Score | 15.3 score on a scale | Standard Deviation 5.4 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Function Score | 17 score on a scale | Standard Deviation 7 |
| Intermediate Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Function Score | 27 score on a scale | Standard Deviation 4 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: ASES Pain Score | 1.3 score on a scale | Standard Deviation 1.6 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Function Score | 26.8 score on a scale | Standard Deviation 6.8 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: ASES Pain Score | 0.3 score on a scale | Standard Deviation 0.7 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Score | 60.9 score on a scale | Standard Deviation 19.9 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Score | 78.9 score on a scale | Standard Deviation 18.4 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Function Score | 26.6 score on a scale | Standard Deviation 9.1 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: ASES Pain Score | 4 score on a scale | Standard Deviation 2.7 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Function Score | 21.1 score on a scale | Standard Deviation 8 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Function Score | 18 score on a scale | Standard Deviation 8.5 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: ASES Pain Score | 0.2 score on a scale | Standard Deviation 0.5 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Score | 92.8 score on a scale | Standard Deviation 15.3 |
| High Partial-Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Score | 93.7 score on a scale | Standard Deviation 11.7 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Function Score | 27.9 score on a scale | Standard Deviation 6.6 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: ASES Pain Score | 4.8 score on a scale | Standard Deviation 2.3 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: ASES Pain Score | 1.8 score on a scale | Standard Deviation 2.2 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: ASES Pain Score | 0.5 score on a scale | Standard Deviation 1.2 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: ASES Pain Score | 0.2 score on a scale | Standard Deviation 0.8 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Function Score | 15.9 score on a scale | Standard Deviation 5.7 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Function Score | 14.6 score on a scale | Standard Deviation 6.7 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Function Score | 27.8 score on a scale | Standard Deviation 4.2 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Score | 52.4 score on a scale | Standard Deviation 18.3 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Score | 65.2 score on a scale | Standard Deviation 19.6 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Score | 94.3 score on a scale | Standard Deviation 11.6 |
| Medium Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Score | 95.6 score on a scale | Standard Deviation 13.2 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Function Score | 15.6 score on a scale | Standard Deviation 7.2 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Function Score | 14.2 score on a scale | Standard Deviation 6.4 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: ASES Pain Score | 5.2 score on a scale | Standard Deviation 2.6 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: Shoulder Score | 67.9 score on a scale | Standard Deviation 16.9 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: ASES Pain Score | 0.5 score on a scale | Standard Deviation 1.2 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: ASES Pain Score | 0.5 score on a scale | Standard Deviation 1.4 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Score | 96.3 score on a scale | Standard Deviation 8.1 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Score | 93.1 score on a scale | Standard Deviation 13.2 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 2 Years: Shoulder Function Score | 29.2 score on a scale | Standard Deviation 1.9 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 1 Year: Shoulder Function Score | 27.4 score on a scale | Standard Deviation 5.8 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | 3 Month: ASES Pain Score | 1.7 score on a scale | Standard Deviation 2 |
| Large Full Thickness Tear | American Shoulder and Elbow Society (ASES) Score | Baseline: Shoulder Score | 48 score on a scale | Standard Deviation 19 |
Secondary
Constant-Murley Shoulder (CMS) Score
The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).
Time frame: Baseline, 3 months, 1 year, and 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | Baseline | 51.6 score on a scale | Standard Error 5.6 |
| Intermediate Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 3 Months | 51.5 score on a scale | Standard Error 13.8 |
| Intermediate Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 1 Year | 82.2 score on a scale | Standard Error 10.4 |
| Intermediate Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 2 Years | 83.3 score on a scale | Standard Error 9.9 |
| High Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 3 Months | 73.7 score on a scale | Standard Error 15.2 |
| High Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 1 Year | 85.6 score on a scale | Standard Error 11.3 |
| High Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | 2 Years | 93.8 score on a scale | Standard Error 6 |
| High Partial-Thickness Tear | Constant-Murley Shoulder (CMS) Score | Baseline | 58.9 score on a scale | Standard Error 19.6 |
| Medium Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 1 Year | 79.1 score on a scale | Standard Error 11.8 |
| Medium Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 3 Months | 63.2 score on a scale | Standard Error 16.8 |
| Medium Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 2 Years | 83.7 score on a scale | Standard Error 9.5 |
| Medium Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | Baseline | 51.2 score on a scale | Standard Error 16.8 |
| Large Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 2 Years | 84.4 score on a scale | Standard Error 9.5 |
| Large Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 3 Months | 65.2 score on a scale | Standard Error 14.7 |
| Large Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | Baseline | 48.5 score on a scale | Standard Error 18.1 |
| Large Full Thickness Tear | Constant-Murley Shoulder (CMS) Score | 1 Year | 85.3 score on a scale | Standard Error 9.6 |
Secondary
Participant Satisfaction
Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following: * Strongly Disagree * Disagree * Neither Agree or Disagree * Agree * Strongly Agree Strongly Disagree indicated the lowest level of satisfaction and Strongly Agree indicated the greatest level of satisfaction.
Time frame: 3 months, 1 year, and 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 2 Year | Strongly Agree | 7 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 1 Year | Neither Agree or Disagree | 1 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 1 Year | Disagree | 0 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 3 Month | Strongly Agree | 4 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 2 Year | Agree | 1 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 1 Year | Strongly Disagree | 0 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 3 Month | Disagree | 0 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 3 Month | Strongly Disagree | 0 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 2 Year | Neither Agree or Disagree | 2 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 2 Year | Disagree | 0 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 3 Month | Neither Agree or Disagree | 2 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 1 Year | Strongly Agree | 9 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 2 Year | Strongly Disagree | 1 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 1 Year | Agree | 2 Participants |
| Intermediate Partial-Thickness Tear | Participant Satisfaction | 3 Month | Agree | 6 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 2 Year | Disagree | 0 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 3 Month | Strongly Disagree | 0 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 3 Month | Disagree | 0 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 3 Month | Neither Agree or Disagree | 3 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 3 Month | Agree | 7 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 3 Month | Strongly Agree | 10 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 1 Year | Strongly Disagree | 0 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 1 Year | Disagree | 0 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 1 Year | Neither Agree or Disagree | 1 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 1 Year | Agree | 3 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 1 Year | Strongly Agree | 16 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 2 Year | Strongly Disagree | 1 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 2 Year | Neither Agree or Disagree | 2 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 2 Year | Agree | 1 Participants |
| High Partial-Thickness Tear | Participant Satisfaction | 2 Year | Strongly Agree | 16 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 2 Year | Strongly Agree | 59 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 2 Year | Disagree | 0 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 1 Year | Strongly Agree | 57 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 3 Month | Disagree | 0 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 1 Year | Neither Agree or Disagree | 0 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 2 Year | Neither Agree or Disagree | 0 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 3 Month | Neither Agree or Disagree | 4 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 3 Month | Strongly Agree | 49 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 3 Month | Strongly Disagree | 0 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 1 Year | Strongly Disagree | 1 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 2 Year | Strongly Disagree | 1 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 2 Year | Agree | 3 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 1 Year | Agree | 7 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 1 Year | Disagree | 1 Participants |
| Medium Full Thickness Tear | Participant Satisfaction | 3 Month | Agree | 13 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 1 Year | Disagree | 0 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 1 Year | Neither Agree or Disagree | 0 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 3 Month | Neither Agree or Disagree | 2 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 2 Year | Agree | 0 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 1 Year | Strongly Agree | 40 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 2 Year | Strongly Disagree | 1 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 3 Month | Disagree | 0 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 1 Year | Agree | 6 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 2 Year | Disagree | 0 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 2 Year | Strongly Agree | 39 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 3 Month | Strongly Agree | 35 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 2 Year | Neither Agree or Disagree | 1 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 1 Year | Strongly Disagree | 2 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 3 Month | Agree | 11 Participants |
| Large Full Thickness Tear | Participant Satisfaction | 3 Month | Strongly Disagree | 1 Participants |
Secondary
Procedure Parameters: Device Implant Time
Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.
Time frame: Intraoperative
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Procedure Parameters: Device Implant Time | 28.00 minutes | Standard Deviation 16.65 |
| High Partial-Thickness Tear | Procedure Parameters: Device Implant Time | 10.50 minutes | Standard Deviation 12.67 |
Secondary
Procedure Parameters: Procedure Technical Success
Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).
Time frame: Intraoperative
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Procedure Parameters: Procedure Technical Success | Device Implant Successful | 33 Participants |
| Intermediate Partial-Thickness Tear | Procedure Parameters: Procedure Technical Success | Device Implant NOT Successful | 0 Participants |
| High Partial-Thickness Tear | Procedure Parameters: Procedure Technical Success | Device Implant Successful | 115 Participants |
| High Partial-Thickness Tear | Procedure Parameters: Procedure Technical Success | Device Implant NOT Successful | 0 Participants |
Secondary
Recovery: Rehabilitation Time
Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.
Time frame: Post-operatively to study completion, approximately 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Recovery: Rehabilitation Time | 14.30 days | Standard Deviation 7.19 |
| High Partial-Thickness Tear | Recovery: Rehabilitation Time | 21.20 days | Standard Deviation 11.08 |
| Medium Full Thickness Tear | Recovery: Rehabilitation Time | 22.50 days | Standard Deviation 11.01 |
| Large Full Thickness Tear | Recovery: Rehabilitation Time | 21.80 days | Standard Deviation 14.44 |
Secondary
Recovery: Return to Normal Daily Activities
Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.
Time frame: Post-operatively to study completion, approximately 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Recovery: Return to Normal Daily Activities | 102.40 days | Standard Deviation 99.95 |
| High Partial-Thickness Tear | Recovery: Return to Normal Daily Activities | 147.30 days | Standard Deviation 125.3 |
| Medium Full Thickness Tear | Recovery: Return to Normal Daily Activities | 130.50 days | Standard Deviation 64.45 |
| Large Full Thickness Tear | Recovery: Return to Normal Daily Activities | 130.90 days | Standard Deviation 84.42 |
Secondary
Recovery: Return to Work
Cumulative number of days between discharge and return to work (employed subjects only).
Time frame: Post-operatively to study completion, approximately 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Recovery: Return to Work | 46.00 days | Standard Deviation 62.99 |
| High Partial-Thickness Tear | Recovery: Return to Work | 58.80 days | Standard Deviation 108.7 |
| Medium Full Thickness Tear | Recovery: Return to Work | 50.00 days | Standard Deviation 72.93 |
| Large Full Thickness Tear | Recovery: Return to Work | 66.50 days | Standard Deviation 83.72 |
Secondary
Recovery: Sling Time
Cumulative number of days index shoulder was in a sling.
Time frame: Post-operatively to study completion, approximately 2 years
Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermediate Partial-Thickness Tear | Recovery: Sling Time | 19.90 days | Standard Deviation 9.39 |
| High Partial-Thickness Tear | Recovery: Sling Time | 26.60 days | Standard Deviation 15.94 |
| Medium Full Thickness Tear | Recovery: Sling Time | 44.60 days | Standard Deviation 43.23 |
| Large Full Thickness Tear | Recovery: Sling Time | 39.20 days | Standard Deviation 20.7 |