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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01481480
First received: November 24, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Full Thickness Rotator Cuff Tear
Procedure: Latissimus dorsi tendon transfer
Procedure: Arthroscopic repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Constant-Murley score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Constant-Murley score at 2 years


Secondary Outcome Measures:
  • Quick Dash [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quick Dash - limb specific patient outcome measurement


Estimated Enrollment: 108
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481480

Contacts
Contact: Michael McKee, MD, FRCS(C) 416-864-5880 mckeem@smh.ca
Contact: Patrick Henry, MD, FRCS(C) 416-820-5880 drpdghenry@gmail.com

Locations
Canada, Ontario
Toronto Western Hospital, St. Michael's Hospital, Holland Centre Recruiting
Toronto, Ontario, Canada
Contact: Michael McKee, MD, FRCS(C)    416-864-5880    mckeem@smh.ca   
Contact: Milena Vicente, RN    416-864-6060 ext 2608    vicentem@smh.ca   
Principal Investigator: Michael McKee, MD, FRCS(C)         
Principal Investigator: Patrick Henry, MD, FRCS(C)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Michael McKee, MD, FRSC(C) St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01481480     History of Changes
Other Study ID Numbers: 16nov2011
Study First Received: November 24, 2011
Last Updated: August 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
shoulder
rotator cuff
tendon transfer
arthroscopic repair

ClinicalTrials.gov processed this record on October 23, 2014