Lower Trapezius Transfer vs Bridging Reconstruction

Sponsor
Nova Scotia Health Authority
Study ID
NCT05925881
Status
Recruiting
Apply to this trial

Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgical Repair of Large to Massive Rotator Cuff Tears — PROCEDURE
    Surgical procedure to reconstruct the rotator cuff

Study Details

The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. The main questions it aims to answer are: * comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance * compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.

Key Dates

First listed
Jun 29, 2023
Start date
Oct 30, 2023
Status verified
Feb 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lower Trapezius Tendon Transfer
    The lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears.
  • Active Comparator: Bridging Reconstruction Repair
    The bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears.

Primary Outcome Measure

Acromiohumeral Distance [ Time Frame: 1 year ]

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