All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Condition: Shoulder Pain; Rotator Cuff Tear
MeSH terms: Shoulder Pain; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): All-Arthroscopic repair; Mini-open repair
Intervention type(s): Procedure; Procedure
Intervention description(s): joint techniques and repair are both performed entirely through the arthroscope; repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder surgery; rotator cuff; arthroscopic repair; mini-open repair