NCT05925881

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Oct 2023Sep 2027

First Submitted

Initial submission to the registry

June 13, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

June 13, 2023

Last Update Submit

February 14, 2025

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

  • Acromiohumeral Distance

    The acromiohumeral distance is the shortest distance between the inferior aspect of the acromion to the closest part of the humeral head. This outcome will be measured by a single blinded assessor who has medical training (sports medicine trained surgical fellow). Acromiohumeral distance will be measured on MRI scans taken at one year post-op.

    1 year

Secondary Outcomes (3)

  • Range of Motion

    1 year

  • Strength

    1 year

  • Patient-reported Outcomes (PROs)

    1 year

Study Arms (2)

Lower Trapezius Tendon Transfer

ACTIVE COMPARATOR

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.

Procedure: Surgical Repair of Large to Massive Rotator Cuff Tears

Bridging Reconstruction Repair

ACTIVE COMPARATOR

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.

Procedure: Surgical Repair of Large to Massive Rotator Cuff Tears

Interventions

Surgical Repair of Large to Massive Rotator Cuff TearsPROCEDURE

Surgical procedure to reconstruct the rotator cuff

Bridging Reconstruction RepairLower Trapezius Tendon Transfer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

5955 Veterans' Memorial Lane Room 2106, VMB

Halifax, Nova Scotia, B3H 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCS(C), Prinicipal Investigator, Professor

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 29, 2023

Study Start

October 30, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

CA(1)