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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128076
• Other study ID #: MCT-82335
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2005
• Last updated: May 26, 2016
• Start date: August 2006
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: December 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear
• Shoulder Pain

Intervention

Procedure:
• All-Arthroscopic repair
joint techniques and repair are both performed entirely through the arthroscope
• 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)

Locations

Country	Name	City	State
Canada	University of Calgary Sport Medicine Centre	Calgary	Alberta
Canada	Walter Mackenzie Centre	Edmonton	Alberta
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario
Canada	St. Joseph's Health Care London	London	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Orthopaedic and Arthritic Hospital	Toronto	Ontario
Canada	PanAm Clinic	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

MacDermid JC, Holtby R, Razmjou H, Bryant D; JOINTS Canada. All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076]. BMC Musculoskelet Disord. 2006 Mar 10;7:25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)		within 2 years	No
Secondary	SF-12		within 2 years	No
Secondary	Work Limitations Scale		within 2 years	No
Secondary	Cuff integrity on imaging		within 1 year post-operative	No
Secondary	Strength		within 2 years	No
Secondary	Range of Motion		within 2 years	No
Secondary	American Shoulder and Elbow Surgeons (ASES) shoulder scale		within 2 years	No
Secondary	Shoulder and Pain Disability Index (SPADI)		Within 2 years	No