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Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears

NCT03617562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

Summary

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.

The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Superior Capsular Reconstruction

Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.

PROCEDURE

Partial Repair

Rotator cuff is repaired with residual defect remaining.

Sponsors & Collaborators

  • Women's College Hospital

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • The Ottawa Hospital

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Patrick Henry, MD, FRCSC · Sunnybrook Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2026-07-31
Completion
2028-07-31

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 NCT03617562 on ClinicalTrials.gov