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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01481480
Recruitment Status : Active, not recruiting
First Posted : November 29, 2011
Last Update Posted : September 12, 2018
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

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 or disease Intervention/treatment Phase
Full Thickness Rotator Cuff Tear Procedure: Latissimus dorsi tendon transfer Procedure: Arthroscopic repair Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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

Primary Outcome Measures :
  1. Constant-Murley score [ Time Frame: 2 years ]
    Constant-Murley score at 2 years

Secondary Outcome Measures :
  1. Quick Dash [ Time Frame: 2 years ]
    Quick Dash - limb specific patient outcome measurement

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481480

Canada, Ontario
Toronto Western Hospital, St. Michael's Hospital, Holland Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Principal Investigator: Michael McKee, MD, FRSC(C) St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01481480     History of Changes
Other Study ID Numbers: 16nov2011
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries