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

Rotator Cuff Tear or Rupture, Not Specified as Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615117
• Other study ID #: ALLOMEND
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: October 2021
• Source: Western Orthopaedics Research and Education Foundation
• Contact: Jackie Bader, MS
• Phone: 303-321-1333
• Email: JBader[@]western-ortho.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Rupture

Locations

Country	Name	City	State
United States	Western Orthopaedics Education and Research Foundation	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Western Orthopaedics Research and Education Foundation	AlloSource

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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. eCollecti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical Failure	Revision Surgery	Within 24 months
Primary	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	Function (Activities of Daily Living)	Function will be assessed via the American Shoulder and Elbow Score (0-100; higher score is better)	24 months
Secondary	Function (Overall Normal rating)	Function will be assessed via the Single Assesment Numeric Evaluation (SANE) (0-100; where 100 is normal)	24 months
Secondary	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
Secondary	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
Secondary	Resilience	Resilience will be assessed via the Brief Resilience Score (BRS) (scores 1-5; higher score = higher resilience)	24 months