All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

May 26, 2016 updated by: Joy MacDermid, McMaster University
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.

Methods/Design:

This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears. A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials (JOINTS) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, constant score), secondary dimensions of health (general health status (SF-12) and work limitations) and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to detect (statistically) a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score ("=0.05). A central methods centre will manage randomization, data management and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria, to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures, will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. The investigators will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2-years post-operatively. As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2-years.

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Sport Medicine Centre
      • Edmonton, Alberta, Canada, T6B 2G7
        • Walter Mackenzie Centre
    • British Columbia
      • New Westminster, British Columbia, Canada, V3S 3W7
        • Royal Columbian Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Panam Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Kingston, Ontario, Canada
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care London
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sports Medicine Clinic
      • Toronto, Ontario, Canada
        • Orthopaedic and Arthritic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery.

  • The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension.

    • SMALL= 0-1 cm;
    • MODERATE =1-3 cm.
  • Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used)

Exclusion Criteria:

Pre-Operative Exclusion Criteria

  • Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder,
  • Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
  • Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
  • Unable to speak or read English,
  • Psychiatric illness that precludes informed consent,
  • Unwilling to be followed for 2 years.

Intra-Operative Exclusion Criteria

  • Large, massive or irreparable cuff tears, extending into the subscapularis or teres minor, which cannot be mobilized to the articular margin or repaired using one or both of the techniques (all arthroscopic or mini-open),
  • Teres minor or subscapularis tears,
  • Inelastic and immobile tendon, which cannot be advanced to articular margin,
  • Co-existing labral pathologies requiring repair with sutures (superior labral anterior posterior [SLAP] II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
All-arthroscopic repair
Procedure: All-Arthroscopic repair
joint techniques and repair are both performed entirely through the arthroscope
Active Comparator: 2
Mini-open repair
Procedure: Mini-open repair
repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
Time Frame: within 2 years
within 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-12
Time Frame: within 2 years
within 2 years
Work Limitations Scale
Time Frame: within 2 years
within 2 years
Cuff integrity on imaging
Time Frame: within 1 year post-operative
within 1 year post-operative
Strength
Time Frame: within 2 years
within 2 years
Range of Motion
Time Frame: within 2 years
within 2 years
American Shoulder and Elbow Surgeons (ASES) shoulder scale
Time Frame: within 2 years
within 2 years
Shoulder and Pain Disability Index (SPADI)
Time Frame: Within 2 years
Within 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Joy C MacDermid, PhD, McMaster University, University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-82335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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