Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05925881

Lower Trapezius Transfer vs Bridging Reconstruction

Led by Nova Scotia Health Authority · Updated on 2025-02-18

60

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Lower Trapezius Transfer vs Bridging Reconstruction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a massive rotator cuff tear confirmed by MRI
  • Tear size greater than 5 cm
  • Two-tendon irreparable rotator cuff tear
  • Adults older than 18 years of age
  • Less than 50% muscle atrophy in the affected shoulder
Not Eligible

You will not qualify if you...

  • Irreparable subscapular tear
  • Glenohumeral osteoarthritis
  • Western Ontario Rotator Cuff Index (WORC) score above 70
  • Uncontrolled diabetes with hemoglobin A1C over 7%
  • Pregnancy
  • Local or systemic infection
  • Inability to understand or follow post-operative instructions
  • Cancer
  • Paralysis of the shoulder
  • Shoulder contracture
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

5955 Veterans' Memorial Lane Room 2106, VMB

Halifax, Nova Scotia, Canada, B3H 2E1

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Lower Trapezius Transfer vs Bridging Reconstruction | DecenTrialz