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

NCT04615117 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2021-10-12

No results posted yet for this study

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

Sponsors & Collaborators

  • AlloSource

    collaborator INDUSTRY

  • Western Orthopaedics Research and Education Foundation

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615117 on ClinicalTrials.gov