Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Study Overview
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Brief Summary
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Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.

Official Title
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Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Device: OrthoADAPT
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons Tear is repairable by surgery using protocol prescribed fixation procedure Patient is able to sign and IRB approved study informed consent Patient is willing and able to return for follow-up appointments and study related procedures Patient is willing to comply with prescribed physical therapy regimen Exclusion Criteria: Emergency, poly trauma patients Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift Cervical spine disease History of adhesive capsulitis in either shoulder Patient whose injury does or may involve litigation Diabetics Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff Patients with grade 3 or 4 glenohumeral arthritis Patients with systemic collage disease Patients with a known hypersensitivity to equine derived materials Active or latent infection Chronic use of immunosuppressive agents Any oral or IM NSAID usage within 5 days before surgery Cancer patients Decisional impaired patients Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RCR without augmentation<br>Rotator cuff repair without OrthoADAPT augmentation | Procedure: Standard of care<br>* Standard of care rotator cuff repair<br>|
| Experimental: RCR with augmentation<br>Rotator cuff repair with OrthoADAPT augmentation | Device: OrthoADAPT<br>* soft tissue augmentation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive and active range of motion |  | Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months | 
| American Shoulder and Elbow Surgeons assessment score |  | Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months | 
| Constant shoulder score |  | Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months | 
| Pain |  | Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | 12 months | 
| Rotator cuff re-rupture and adhesions |  | 6 weeks, 3, 4, 6, 12 and 24 months | 
| Incidence of device or procedure related adverse events |  | 6 weeks, 3, 4, 6, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff tear, rotator cuff repair