Recruiting

Lower Trapezius Transfer vs. Bridging Reconstruction

Sponsor:

Nova Scotia Health Authority

Code:

NCT05925881

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical Repair of Large to Massive Rotator Cuff Tears

Study Details

Brief summary:

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.

Conditions

Rotator Cuff Tears

Study ID

NCT05925881

Start date

Oct 30, 2023

Status verified date

Feb, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
  • tear size >5cm
  • two-tendon, irreparable tear
  • competent adult (>18 years of age)
  • <50% muscle atrophy.

Exclusion Criteria:

  • irreparable subscapular tear
  • glenohumeral osteoarthritis
  • WORC score > 70
  • uncontrolled diabetes (Hgb A1C >7%)
  • pregnancy
  • presence of local or systemic infection
  • inability to cooperate with and/or comprehend post-operative instructions
  • cancer
  • paralysis of the shoulder
  • contracture of the shoulder
  • inability to provide informed consent

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Surgical Repair of Large to Massive Rotator Cuff Tears

Surgical procedure to reconstruct the rotator cuff

Primary outcome measure

  • Acromiohumeral Distance [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

5955 Veterans' Memorial Lane Room 2106, VMB

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E1

Contacts

Ivan Wong, Dr.

9024737627research@drivanwong.com

Devan Pancura, MSc

9024737627research@drivanwong.con

Principal Investigator:

Ivan Wong, Dr.

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-18.