Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
AlloSource
Western Orthopaedics Research and Education Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acromiohumeral interval change | 24 months | Xrays will be used to compare the amount of superior humeral migration between 12 month xrays and 24 month xrays |
| Clinical Failure | Within 24 months | Revision Surgery |
| Rotator Cuff Integrity and Graft Incorporation | 24 months | These will be assessed via MRI with Arthrogram- changes will be compared between the 12 and 24 month time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 24 months | Function will be assessed by measuring active range of motion (forward flexion, abduction, external rotation, internal rotation) with a goniometer |
| Function (Activities of Daily Living) | 24 months | Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better) |
| Resilience | 24 months | Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience) |
| Function (Overall Normal rating) | 24 months | Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal) |
| Shoulder Pain | 24 months | Pain will be assessed on a Visual Analog Scale (VAS) (0-10; where 0 is no pain and 10 is the worst pain imaginable) |
Countries
United States
Contacts
Primary ContactJackie Bader, MS
Backup ContactLibby Mauter, MS/PT
Outcome results
None listed