Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
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ClinicalTrials.gov Identifier: NCT01481480 |
Recruitment Status
:
Recruiting
First Posted
: November 29, 2011
Last Update Posted
: November 27, 2017
|
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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) |
Estimated Enrollment : | 108 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 2018 |
Estimated Study Completion Date : | December 2018 |

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
|
- Constant-Murley score [ Time Frame: 2 years ]Constant-Murley score at 2 years
- Quick Dash [ Time Frame: 2 years ]Quick Dash - limb specific patient outcome measurement

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Ages Eligible for Study: | 40 Years to 65 Years (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.)

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 ClinicalTrials.gov identifier (NCT number): NCT01481480
Contact: Michael McKee, MD, FRCS(C) | 416-864-5880 | mckeem@smh.ca | |
Contact: Patrick Henry, MD, FRCS(C) | 416-820-5880 | drpdghenry@gmail.com |
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) |
Principal Investigator: | Michael McKee, MD, FRSC(C) | St. Michael's Hospital, Toronto |
Responsible Party: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT01481480 History of Changes |
Other Study ID Numbers: |
16nov2011 |
First Posted: | November 29, 2011 Key Record Dates |
Last Update Posted: | November 27, 2017 |
Last Verified: | November 2017 |
Keywords provided by St. Michael's Hospital, Toronto:
shoulder rotator cuff tendon transfer arthroscopic repair |
Additional relevant MeSH terms:
Rotator Cuff Injuries Rupture Wounds and Injuries Shoulder Injuries Tendon Injuries |