RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Intervention / Treatment

-

Contacts and Locations

Denver

Western Orthopaedics Education and Research Foundation, Denver, Colorado, United States, 80218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Western Orthopaedics Research and Education Foundation,

Armodios Hatzidakis, MD, PRINCIPAL_INVESTIGATOR, Western Orthopaedics Education and Research Foundation

Study Record Dates

2025-12