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

Western Orthopaedics Research and Education Foundation

Status: Enrolling

Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04615117

ALLOMEND

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Study Group

Description:

Patients treated with Superior Capsular Reconstruction with Allomend