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

NCT01481480 | Unknown

• 1 other identifier: 16nov2011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

shoulder; rotator cuff; tendon transfer; arthroscopic repair

Outcome Measures

Primary Outcomes (1)

• Constant-Murley score

  Constant-Murley score at 2 years

  2 years

Secondary Outcomes (1)

• Quick Dash

  2 years

Study Arms (2)

Latissimus dorsi tendon transfer

EXPERIMENTAL

A Latissimus dorsi tendon transfer is performed

Procedure: Latissimus dorsi tendon transfer

Arthroscopic repair

ACTIVE COMPARATOR

An arthroscopic repair is performed

Procedure: Arthroscopic repair

Interventions

Latissimus dorsi tendon transfer PROCEDURE

Latissimus dorsi tendon transfer

Latissimus dorsi tendon transfer

Arthroscopic repair PROCEDURE

Arthroscopic repair

Arthroscopic repair

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Unity Health Toronto: lead
• University Health Network, Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

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

Toronto, Ontario, Canada

Location

Study Officials

• Michael McKee, MD, FRSC(C)

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: August 1, 2012
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

CA (1)