Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Study Overview
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Brief Summary
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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.

Official Title
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Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Conditions
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Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear

Intervention / Treatment
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* Device: Bioinductive implant
* Device: Surgical repair


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Subjects enrolled in the study MUST meet all of the following criteria: At least 21 years of age 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 Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections MRI of the shoulder within 60 days prior to the study procedure Willing to comply with the prescribed post-operative rehabilitation program Willing to be available for each protocol-required follow-up examination 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 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: Massive rotator cuff tears (≥ 5 cm) Acute rotator cuff tears less than 12 months from injury Previous rotator cuff surgery on the index shoulder Instability of the index shoulder Chondromalacia of index shoulder ≥ Grade 3 Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2 Calcification of the index shoulder rotator cuff Genetic collagen disease History of insulin dependent diabetes History of auto-immune or immunodeficiency disorders History of chronic inflammatory disorders Oral steroid use in last 2 months or injectable steroid use in last 4 weeks History of heavy smoking (> 1 pack per day) within last 6 months Hypersensitivity to bovine-derived materials Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation History of cognitive or mental health status that interferes with study participation

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial-Thickness Tear<br>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant. | Device: Bioinductive implant<br> <br> * Other names: REGENETEN™ Bioinductive Implant System.;|
| Experimental: Full Thickness Tear<br>Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. | Device: Bioinductive implant<br> <br> * Other names: REGENETEN™ Bioinductive Implant System.;Device: Surgical repair<br>* Surgical repair with commercially-available sutures/suture anchors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Pre-operatively (baseline) to 3 month, 1 year, and 2 year | 
| 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: Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? Was there evidence of bursitis in the shoulder? Does the new tissue resemble normal tendon tissue? Does the underlying tendon resemble normal tendon tissue? Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? | 3 months, 1 year, and 2 years | 
| 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% | 3 months, 1 year, and 2 years | 
| 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. | 3 months, 1 year, and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative | 
| 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). | Intraoperative | 
| American Shoulder and Elbow Society (ASES) Score | The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows: ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better). ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better). 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). | Baseline, 3 month, 1 year, and 2 years | 
| 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). | Baseline, 3 months, 1 year, and 2 years | 
| Recovery: Sling Time | Cumulative number of days index shoulder was in a sling. | Post-operatively to study completion, approximately 2 years | 
| Recovery: Rehabilitation Time | Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder. | Post-operatively to study completion, approximately 2 years | 
| Recovery: Return to Work | Cumulative number of days between discharge and return to work (employed subjects only). | Post-operatively to study completion, approximately 2 years | 
| 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. | Post-operatively to study completion, approximately 2 years | 
| 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. | 3 months, 1 year, and 2 years |