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

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

A Multicenter, Randomized Controlled Trial Comparing Functional Outcomes After Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481480
• Other study ID #: 16nov2011
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Intervention

Procedure:
• Latissimus dorsi tendon transfer
Latissimus dorsi tendon transfer
• Arthroscopic repair
Arthroscopic repair

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, St. Michael's Hospital, Holland Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Sunnybrook Health Sciences Centre, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant-Murley score	Constant-Murley score at 2 years	2 years
Secondary	Quick Dash	Quick Dash - limb specific patient outcome measurement	2 years