An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction

Study Overview
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Brief Summary
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Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.

Detailed Description
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Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears.Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes. We predict there will be significant improvement in radiographic, clinical, and patient reported outcomes in patients undergoing SCR for extensive, primarily irreparable rotator cuff tears when AlloMend allograft is utilized.

Official Title
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An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction

Conditions
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Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are undergoing SCR for massive rotator cuff Adult patients (≥18) Pre-operative MRI obtained within 26 weeks prior to surgery Must have 3 out of 5 external rotation strength Must have intact teres minor Exclusion Criteria: Worker's Compensation Case Persons with a mental or cognitive disability deemed significant enough that they would not be capable of complying with a restricted rehabilitation program or completing the outcome measures Patients with known contraindications to MRI Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction Acute fractures of humerus, clavicle, scapula Inability to speak and/or understand English Intra-Op Exclusion Criteria: Anterosuperior escape of the glenohumeral joint due to a completely incompetent anterosuperior cuff and coracoacromial ligament (CAL) Unable to fix the graft on the humeral side utilizing a double row repair Inability to address subscapularis pathology Diffuse bipolar cartilage loss

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Patients treated with Superior Capsular Reconstruction with Allomend | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acromiohumeral interval change | Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays | 24 months | 
| Clinical Failure | Revision Surgery | Within 24 months | 
| Rotator Cuff Integrity and Graft Incorporation | These will be assessed via MRI with Arthrogram- changes will be compared between the 12 and 24 month time points | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function (Activities of Daily Living) | Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better) | 24 months | 
| Function (Overall Normal rating) | Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal) | 24 months | 
| Shoulder Pain | Pain will be assessed on a Visual Analog Scale (VAS) (0-10; where 0 is no pain and 10 is the worst pain imaginable) | 24 months | 
| Range of Motion | Function will be assessed by measuring active range of motion (forward flexion, abduction, external rotation, internal rotation) with a goniometer | 24 months | 
| Resilience | Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience) | 24 months |