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| Name | Class |
|---|---|
| AlloSource | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Patients treated with Superior Capsular Reconstruction with Allomend |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Intra-Op Exclusion Criteria:
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Patients with massive rotator cuff tears
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jackie Bader, MS | Contact | 303-321-1333 | JBader@western-ortho.com | |
| Libby Mauter, MS/PT | Contact | 303-321-1333 | LMauter@western-ortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Armodios Hatzidakis, MD | Western Orthopaedics Education and Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Orthopaedics Education and Research Foundation | Recruiting | Denver | Colorado | 80218 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26944572 | Result | Mihata T, McGarry MH, Kahn T, Goldberg I, Neo M, Lee TQ. Biomechanical Role of Capsular Continuity in Superior Capsule Reconstruction for Irreparable Tears of the Supraspinatus Tendon. Am J Sports Med. 2016 Jun;44(6):1423-30. doi: 10.1177/0363546516631751. Epub 2016 Mar 4. | |
| 27552457 | Result | Adams CR, Denard PJ, Brady PC, Hartzler RU, Burkhart SS. The Arthroscopic Superior Capsular Reconstruction. Am J Orthop (Belle Mead NJ). 2016 Jul-Aug;45(5):320-4. |
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aggregate data
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| 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 |
| 29456069 | Result | Pennington WT, Bartz BA, Pauli JM, Walker CE, Schmidt W. Arthroscopic Superior Capsular Reconstruction With Acellular Dermal Allograft for the Treatment of Massive Irreparable Rotator Cuff Tears: Short-Term Clinical Outcomes and the Radiographic Parameter of Superior Capsular Distance. Arthroscopy. 2018 Jun;34(6):1764-1773. doi: 10.1016/j.arthro.2018.01.009. Epub 2018 Feb 15. |
| 32266343 | Result | Polacek M. Arthroscopic Superior Capsular Reconstruction With Acellular Porcine Dermal Xenograft for the Treatment of Massive Irreparable Rotator Cuff Tears. Arthrosc Sports Med Rehabil. 2019 Nov 13;1(1):e75-e84. doi: 10.1016/j.asmr.2019.08.001. eCollection 2019 Nov. |
| 31864817 | Result | Burkhart SS, Pranckun JJ, Hartzler RU. Superior Capsular Reconstruction for the Operatively Irreparable Rotator Cuff Tear: Clinical Outcomes Are Maintained 2 Years After Surgery. Arthroscopy. 2020 Feb;36(2):373-380. doi: 10.1016/j.arthro.2019.08.035. Epub 2019 Dec 18. |