RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-08-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04615117

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects who are undergoing SCR for massive rotator cuff
  2. * Adult patients (≥18)
  3. * Pre-operative MRI obtained within 26 weeks prior to surgery
  4. * Must have 3 out of 5 external rotation strength
  5. * Must have intact teres minor
  1. * Worker's Compensation Case
  2. * 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
  3. * Patients with known contraindications to MRI
  4. * Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction
  5. * Acute fractures of humerus, clavicle, scapula
  6. * Inability to speak and/or understand English

Contacts and Locations

Study Contact

Jackie Bader, MS
CONTACT
303-321-1333
JBader@western-ortho.com
Libby Mauter, MS/PT
CONTACT
303-321-1333
LMauter@western-ortho.com

Principal Investigator

Armodios Hatzidakis, MD
PRINCIPAL_INVESTIGATOR
Western Orthopaedics Education and Research Foundation

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Western Orthopaedics Research and Education Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Rotator Cuff Tear or Rupture, Not Specified as Traumatic