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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01481480 History of Changes
Other Study ID Numbers:	16nov2011
First Posted:	November 29, 2011
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