Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
Primary Purpose
Full Thickness Rotator Cuff Tear
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Latissimus dorsi tendon transfer
Arthroscopic repair
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Rotator Cuff Tear focused on measuring shoulder, rotator cuff, tendon transfer, arthroscopic repair
Eligibility 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.)
Sites / Locations
- Toronto Western Hospital, St. Michael's Hospital, Holland Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Latissimus dorsi tendon transfer
Arthroscopic repair
Arm Description
A Latissimus dorsi tendon transfer is performed
An arthroscopic repair is performed
Outcomes
Primary Outcome Measures
Constant-Murley score
Constant-Murley score at 2 years
Secondary Outcome Measures
Quick Dash
Quick Dash - limb specific patient outcome measurement
Full Information
NCT ID
NCT01481480
First Posted
November 24, 2011
Last Updated
October 19, 2020
Sponsor
Unity Health Toronto
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01481480
Brief Title
Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
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 Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
University Health Network, Toronto, Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
Keywords
shoulder, rotator cuff, tendon transfer, arthroscopic repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latissimus dorsi tendon transfer
Arm Type
Experimental
Arm Description
A Latissimus dorsi tendon transfer is performed
Arm Title
Arthroscopic repair
Arm Type
Active Comparator
Arm Description
An arthroscopic repair is performed
Intervention Type
Procedure
Intervention Name(s)
Latissimus dorsi tendon transfer
Intervention Description
Latissimus dorsi tendon transfer
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic repair
Intervention Description
Arthroscopic repair
Primary Outcome Measure Information:
Title
Constant-Murley score
Description
Constant-Murley score at 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quick Dash
Description
Quick Dash - limb specific patient outcome measurement
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McKee, MD, FRSC(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, St. Michael's Hospital, Holland Centre
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears
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