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

Western Orthopaedics Research and Education Foundation25 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acromiohumeral interval change

Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays

Time frame: 24 months

Clinical Failure

Revision Surgery

Time frame: 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

Time frame: 24 months

Secondary Outcomes

Function (Activities of Daily Living)

Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better)

Time frame: 24 months

Function (Overall Normal rating)

Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal)

Time frame: 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)

Time frame: 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

Time frame: 24 months

Resilience

Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience)

Time frame: 24 months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts