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

NCT04615117 | Unknown

• 1 other identifier: ALLOMEND
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Function (Activities of Daily Living)

  24 months

• Function (Overall Normal rating)

  24 months

• Shoulder Pain

  24 months

• Range of Motion

  24 months

• Resilience

  24 months

Study Arms (1)

Study Group

Patients treated with Superior Capsular Reconstruction with Allomend

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with massive rotator cuff tears

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Western Orthopaedics Research and Education Foundation: lead
• AlloSource: collaborator

Study Sites (1)

Western Orthopaedics Education and Research Foundation

Denver, Colorado, 80218, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 26944572 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.

  PMID: 27552457 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.

  PMID: 29456069 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.

  PMID: 32266343 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.

  PMID: 31864817 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Armodios Hatzidakis, MD

  Western Orthopaedics Education and Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Bader, MS

CONTACT

303-321-1333; JBader@western-ortho.com

Libby Mauter, MS/PT

CONTACT

303-321-1333; LMauter@western-ortho.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: August 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)