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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01481480
Other study ID # 16nov2011
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design


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
See also
  Status Clinical Trial Phase
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Completed NCT01557309 - Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear N/A
Completed NCT01819909 - Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation N/A
Terminated NCT04115644 - Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial Phase 4
Completed NCT01849458 - BioFiber Scaffold Post-Market Observational Study N/A
Completed NCT01499992 - Rehabilitation of Reconstructed Shoulder Rotator Cuff N/A
Completed NCT02915588 - Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair N/A
Completed NCT01987973 - Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone N/A
Completed NCT03021733 - A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears N/A
Completed NCT02740946 - Enhanced Function and Quality of Life Following 5 Months of Exercise Therapy for Patients With Rotator Cuff Tears N/A
Completed NCT02750176 - Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears Early Phase 1