Rotator Cuff Tear
Conditions
Brief summary
The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant. Both performance and safety data will be collected.
Detailed description
Study Title Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs Sponsor Cayenne Medical, Inc., a Zimmer Biomet company Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both preoperative assessments and follow-up assessments at 3 months, 6 months, and 12 months. Clinical Phase Postmarket Number of Sites Up to ten sites in the U.S. Study Duration per Subject Subjects will be enrolled in the study for up to 12 months. Primary Objective The primary objective of this study is to assess survivorship (lack of reoperation/device removal) with the use of the BioWick SureLock implant. Secondary Objective The secondary objectives of this study are: * To document the postmarket effectiveness of the BioWick SureLock implant using ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, and 12 months postoperative. * To document the postmarket effectiveness of the BioWick SureLock implant using range of motion (ROM) measurements with the corresponding assessments made at 3 months and 6 months postoperative. * To document device safety via device-related adverse events reported over the course of the study.
Interventions
DEVICEBioWick SureLock Implant
The BioWick SureLock implant is a device for shoulder and extremity surgery, constructed of Ultra High Molecular Weight Polyethylene Suture. BioWick SureLock is uniquely designed to minimize these risks by avoiding manual tensioning with an inserter mechanism that ensures that the implant is consistently deployed below the cortex.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of rotator cuff tear which is greater than or equal to 1.5 cm and less than or equal to 4.0 cm full thickness of either the supraspinatus or infraspinatus determined by MRI which has not been previously repaired; 2. Goutallier Stage 2 or less; 3. Patte Stage II (mid humeral head retraction); 4. Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes; 5. Subject is skeletally mature at the surgical site; 6. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.
Exclusion criteria
1. Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement); 2. Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions; 3. If female, subject is pregnant; 4. Presence of local or systemic infection; 5. Suprascapular nerve compression requiring release or documented by EMG-NCV; 6. Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance; 7. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation; 8. Insufficient blood supply or previous infection which may hinder the healing process; 9. Subject conditions including: insufficient quantity or quality of bone or soft tissue, or immature bone where the device may impact or disrupt the growth plate; 10. Subject is a prisoner or member of another vulnerable population; 11. Cortisone injection within 6 weeks prior to surgical treatment; 12. Use of immune suppressants or chemotherapeutic medications within the last 12 months; 13. Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Not Requiring Removal or Reoperation of the Implant | 12 months | The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Not Requiring Removal or Reoperation of the Implant | 3 months, 6 months | Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship). |
| American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score | Preoperative, 3 months, 6 months, 1 year | Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best. |
| Visual Analogue Scale (VAS) Pain Score | Preoperative, 3 months, 6 months, 1 year | A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Possible scores range from 0 (no pain) to 10 (very much pain). |
| Device Safety | 1 year | Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as Definitely or Possibly related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results. |
| The Veterans RAND 12 (VR-12) Item Health Survey Mental Score | Preoperative, 3 months, 6 months, 1 year | A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale). |
| Range of Motion (ROM) - Active Forward Elevation | Preoperative, 3 months, 6 months, 1 year | Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees. |
| The Veterans RAND 12 (VR-12) Item Health Survey Physical Score | Preoperative, 3 months, 6 months, 1 year | A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale). |
Countries
United States
Participant flow
Pre-assignment details
Any screened subjects who met any of the exclusion criteria were excluded from participation in this study and were not considered enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| BioWick SureLock Implant This arm will include all subjects who are implanted with the BioWick SureLock Implant. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | BioWick SureLock Implant |
|---|---|
| Age, Continuous | 60.5 years |
| Current alcohol use No | 33 Participants |
| Current alcohol use Yes | 38 Participants |
| Current tobacco use No | 63 Participants |
| Current tobacco use Yes | 8 Participants |
| Duration of Symptoms/Time Since Injury | 14.9 months |
| Prior Shoulder Operations No | 49 Participants |
| Prior Shoulder Operations Yes | 22 Participants |
| Race/Ethnicity, Customized African Origin | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 56 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants |
| Region of Enrollment United States | 71 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 71 |
| other Total, other adverse events | 29 / 71 |
| serious Total, serious adverse events | 5 / 71 |
Outcome results
Primary
Number of Participants Not Requiring Removal or Reoperation of the Implant
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Time frame: 12 months
Population: In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioWick SureLock Implant | Number of Participants Not Requiring Removal or Reoperation of the Implant | 69 Participants |
Secondary
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time frame: Preoperative, 3 months, 6 months, 1 year
Population: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioWick SureLock Implant | American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score | 12 months | 92.5 units on a scale | Standard Deviation 10.2 |
| BioWick SureLock Implant | American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score | Preoperative | 44.2 units on a scale | Standard Deviation 17.1 |
| BioWick SureLock Implant | American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score | 3 months | 66.7 units on a scale | Standard Deviation 19.9 |
| BioWick SureLock Implant | American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score | 6 months | 82.9 units on a scale | Standard Deviation 15.8 |
Secondary
Device Safety
Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as Definitely or Possibly related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results.
Time frame: 1 year
Population: All enrolled subjects were analyzed for device safety through the end of their study participation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BioWick SureLock Implant | Device Safety | 8 device-related adverse events |
Secondary
Number of Participants Not Requiring Removal or Reoperation of the Implant
Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Time frame: 3 months, 6 months
Population: In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BioWick SureLock Implant | Number of Participants Not Requiring Removal or Reoperation of the Implant | 3 months | 69 Participants |
| BioWick SureLock Implant | Number of Participants Not Requiring Removal or Reoperation of the Implant | 6 months | 69 Participants |
Secondary
Range of Motion (ROM) - Active Forward Elevation
Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees.
Time frame: Preoperative, 3 months, 6 months, 1 year
Population: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioWick SureLock Implant | Range of Motion (ROM) - Active Forward Elevation | Preoperative | 116.1 degrees | Standard Deviation 42.1 |
| BioWick SureLock Implant | Range of Motion (ROM) - Active Forward Elevation | 3 months | 132.1 degrees | Standard Deviation 30.8 |
| BioWick SureLock Implant | Range of Motion (ROM) - Active Forward Elevation | 6 months | 153.4 degrees | Standard Deviation 23.3 |
| BioWick SureLock Implant | Range of Motion (ROM) - Active Forward Elevation | 1 year | 162.1 degrees | Standard Deviation 18.7 |
Secondary
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Time frame: Preoperative, 3 months, 6 months, 1 year
Population: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Mental Score | Preoperative | 53.7 score on a scale | Standard Deviation 11.3 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Mental Score | 3 months | 54.8 score on a scale | Standard Deviation 11.2 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Mental Score | 6 months | 55.9 score on a scale | Standard Deviation 9.1 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Mental Score | 1 year | 57.0 score on a scale | Standard Deviation 6.5 |
Secondary
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Time frame: Preoperative, 3 months, 6 months, 1 year
Population: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Physical Score | Preoperative | 35.3 score on a scale | Standard Deviation 8.3 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Physical Score | 3 months | 39.9 score on a scale | Standard Deviation 8.4 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Physical Score | 6 months | 46.7 score on a scale | Standard Deviation 8.7 |
| BioWick SureLock Implant | The Veterans RAND 12 (VR-12) Item Health Survey Physical Score | 1 year | 49.2 score on a scale | Standard Deviation 7.3 |
Secondary
Visual Analogue Scale (VAS) Pain Score
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Possible scores range from 0 (no pain) to 10 (very much pain).
Time frame: Preoperative, 3 months, 6 months, 1 year
Population: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioWick SureLock Implant | Visual Analogue Scale (VAS) Pain Score | 3 months | 2.1 score on a scale | Standard Deviation 2.4 |
| BioWick SureLock Implant | Visual Analogue Scale (VAS) Pain Score | 6 months | 1.2 score on a scale | Standard Deviation 1.6 |
| BioWick SureLock Implant | Visual Analogue Scale (VAS) Pain Score | Preoperative | 5.5 score on a scale | Standard Deviation 2.4 |
| BioWick SureLock Implant | Visual Analogue Scale (VAS) Pain Score | 1 year | 0.5 score on a scale | Standard Deviation 0.9 |