RecruitingNot ApplicableNCT05925881

Lower Trapezius Transfer vs Bridging Reconstruction

Arthroscopic Assisted Lower Trapezius Tendon Transfer vs Bridging Repair for Irreparable Rotator Cuff Tears: A Randomized Controlled Trial


Sponsor

Nova Scotia Health Authority

Enrollment

60 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

PROCEDURESurgical Repair of Large to Massive Rotator Cuff Tears

Surgical procedure to reconstruct the rotator cuff


Locations(1)

5955 Veterans' Memorial Lane Room 2106, VMB

Halifax, Nova Scotia, Canada

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