Recruiting

Allomend(R) HD

Sponsor:

Western Orthopaedics Research and Education Foundation

Code:

NCT04615117

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04615117

Start date

Aug 1, 2021

Status verified date

Oct, 2021

Completion date

Dec, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Group

Patients treated with Superior Capsular Reconstruction with Allomend

Primary outcome measure

  • Acromiohumeral interval change [ Time Frame: 24 months ]
  • Clinical Failure [ Time Frame: Within 24 months ]
  • Rotator Cuff Integrity and Graft Incorporation [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Jackie Bader, MS

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

Libby Mauter, MS/PT

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

Locations

Western Orthopaedics Education and Research Foundation

Recruiting

Denver, Colorado, United States, 80218

Contacts

Jackie Bader, MS

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

LIbby Mauter, MS/PT

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

Principal Investigator:

Armodios Hatzidakis, MD

More Information

Sponsor

Western Orthopaedics Research and Education Foundation

Last update posted

Oct 12, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Orthopaedics Research and Education Foundation on 2021-10-12.