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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Joy MacDermid, McMaster University
ClinicalTrials.gov Identifier:
NCT00128076
First received: August 5, 2005
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Rotator Cuff Tear
Procedure: All-Arthroscopic repair
Procedure: Mini-open repair
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC) [ Time Frame: within 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12 [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Work Limitations Scale [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Cuff integrity on imaging [ Time Frame: within 1 year post-operative ] [ Designated as safety issue: No ]
  • Strength [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • American Shoulder and Elbow Surgeons (ASES) shoulder scale [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Shoulder and Pain Disability Index (SPADI) [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: August 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128076

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Walter Mackenzie Centre
Edmonton, Alberta, Canada, T6B 2G7
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3S 3W7
Canada, Manitoba
PanAm Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Kingston General Hospital
Kingston, Ontario, Canada
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada, N6A 3K7
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Orthopaedic and Arthritic Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Joy C MacDermid, PhD McMaster University, University of Western Ontario
  More Information

Publications:
Responsible Party: Joy MacDermid, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00128076     History of Changes
Other Study ID Numbers: MCT-82335
Study First Received: August 5, 2005
Last Updated: April 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
shoulder surgery
rotator cuff
arthroscopic repair
mini-open repair

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014