Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior.

Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.

Study Overview

• Status: Unknown
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: Procedure: Latissimus dorsi tendon transfer; Procedure: Arthroscopic repair

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto Western Hospital, St. Michael's Hospital, Holland Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women aged 40 to 65 years of age
• Massive rotator cuff tear, identified by MRI as being greater than 4cm in greatest diameter.
• Provision of informed consent

Exclusion Criteria:

• Absence of functioning latissimus dorsi muscle (assessed by "cough test"
• Absence of subscapularis muscle insertion (assessed by MRI)
• Glenohumeral arthritis of Grade 2 or higher, including evidence of acromio-humeral arthritis
• Acute tears (identifiable injury which precluded symptoms in past 6 months)
• Neurologic injury causing paralysis of affected shoulder girdle/arm
• Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
• Anticipated problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Latissimus dorsi tendon transfer; A Latissimus dorsi tendon transfer is performed	Procedure: Latissimus dorsi tendon transfer; Latissimus dorsi tendon transfer
Active Comparator: Arthroscopic repair; An arthroscopic repair is performed	Procedure: Arthroscopic repair; Arthroscopic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley score	Constant-Murley score at 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Dash	Quick Dash - limb specific patient outcome measurement	2 years

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University Health Network, Toronto; Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Michael McKee, MD, FRSC(C), Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: arthroscopic repair; shoulder; rotator cuff; tendon transfer
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 16nov2011