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

NCT ID: NCT01481480

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2021-12-31

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.

Conditions

Full Thickness Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Latissimus dorsi tendon transfer

A Latissimus dorsi tendon transfer is performed

Group Type: EXPERIMENTAL

Latissimus dorsi tendon transfer

Intervention Type: PROCEDURE

Latissimus dorsi tendon transfer

Arthroscopic repair

An arthroscopic repair is performed

Group Type: ACTIVE_COMPARATOR

Arthroscopic repair

Intervention Type: PROCEDURE

Arthroscopic repair

Interventions

Latissimus dorsi tendon transfer

Latissimus dorsi tendon transfer

Intervention Type: PROCEDURE

Arthroscopic repair

Arthroscopic repair

Intervention Type: PROCEDURE

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.)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael McKee, MD, FRSC(C)

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

Toronto Western Hospital, St. Michael's Hospital, Holland Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

16nov2011

Identifier Type: -

Identifier Source: org_study_id