All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 1N4
- University of Calgary Sport Medicine Centre
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Edmonton, Alberta, 캐나다, T6B 2G7
- Walter Mackenzie Centre
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British Columbia
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New Westminster, British Columbia, 캐나다, V3S 3W7
- Royal Columbian Hospital
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3M 3E4
- Panam Clinic
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Ontario
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Hamilton, Ontario, 캐나다, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Kingston, Ontario, 캐나다
- Kingston General Hospital
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London, Ontario, 캐나다, N6A 4V2
- St. Joseph's Health Care London
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London, Ontario, 캐나다, N6A 3K7
- Fowler Kennedy Sports Medicine Clinic
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Toronto, Ontario, 캐나다
- Orthopaedic and Arthritic Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 1
All-arthroscopic repair
|
joint techniques and repair are both performed entirely through the arthroscope
|
|
활성 비교기: 2
Mini-open repair
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repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
기간: within 2 years
|
within 2 years
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
SF-12
기간: within 2 years
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within 2 years
|
|
Work Limitations Scale
기간: within 2 years
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within 2 years
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Cuff integrity on imaging
기간: within 1 year post-operative
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within 1 year post-operative
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Strength
기간: within 2 years
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within 2 years
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Range of Motion
기간: within 2 years
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within 2 years
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American Shoulder and Elbow Surgeons (ASES) shoulder scale
기간: within 2 years
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within 2 years
|
|
Shoulder and Pain Disability Index (SPADI)
기간: Within 2 years
|
Within 2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joy C MacDermid, PhD, McMaster University, University of Western Ontario
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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