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Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

NCT01987973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-03-08

No results posted yet for this study

Summary

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

Conditions

  • Rotator Cuff Syndrome
  • Rotator Cuff Injury
  • Disorder of Rotator Cuff
  • Full Thickness Rotator Cuff Tear
  • Skin Graft (Allograft) (Autograft) Failure

Interventions

PROCEDURE

Partial Rotator Cuff Repair

This is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated.

PROCEDURE

Partial Rotator Cuff Repair with Allograft Augmentation

Patients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated.

Sponsors & Collaborators

  • Ivan Wong

    lead OTHER

Principal Investigators

  • Ivan H Wong, MD FRCS(C) · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-12-31
Completion
2021-03-31

Countries

  • Canada

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 NCT01987973 on ClinicalTrials.gov