Clinical trial NCT00128076: All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Official title: All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shoulder Pain
Rotator Cuff Tear
Keywords: shoulder surgery
rotator cuff
arthroscopic repair
mini-open repair
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Physicians' Services Incorporated Foundation
First posted: 2005-08-09
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
timeFrame: within 2 years
Secondary outcomes:
measure: SF-12
timeFrame: within 2 years
measure: Work Limitations Scale
timeFrame: within 2 years
measure: Cuff integrity on imaging
timeFrame: within 1 year post-operative
measure: Strength
timeFrame: within 2 years
measure: Range of Motion
timeFrame: within 2 years
measure: American Shoulder and Elbow Surgeons (ASES) shoulder scale
timeFrame: within 2 years
measure: Shoulder and Pain Disability Index (SPADI)
timeFrame: Within 2 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
city: Edmonton
country: Canada
facility: Walter Mackenzie Centre
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: PanAm Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Toronto
country: Canada
facility: Orthopaedic and Arthritic Hospital
state: Ontario
Study officials:
affiliation: McMaster University, University of Western Ontario
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1471-2474-7-25.
citation: MacDermid JC, Bryant D, Holtby R, Razmjou H, Faber K; JOINTS Canada; Balyk R, Boorman R, Sheps D, McCormack R, Athwal G, Hollinshead R, Lo I, Bicknell R, Mohtadi N, Bouliane M, Glasgow D, Lebel ME, Lalani A, Moola FO, Litchfield R, Moro J, MacDonald P, Bergman JW, Bury J, Drosdowech D. Arthroscopic Versus Mini-open Rotator Cuff Repair: A Randomized Trial and Meta-analysis. Am J Sports Med. 2021 Oct;49(12):3184-3195. doi: 10.1177/03635465211038233. Epub 2021 Sep 15.