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

26. maj 2016 opdateret af: Joy MacDermid, McMaster University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

275

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Sport Medicine Centre
      • Edmonton, Alberta, Canada, T6B 2G7
        • Walter Mackenzie Centre
    • British Columbia
      • New Westminster, British Columbia, Canada, V3S 3W7
        • Royal Columbian Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Panam Clinic
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Kingston, Ontario, Canada
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care London
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sports Medicine Clinic
      • Toronto, Ontario, Canada
        • Orthopaedic and Arthritic Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
All-arthroscopic repair
Procedure: All-Arthroscopic repair
joint techniques and repair are both performed entirely through the arthroscope
Aktiv komparator: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)
Tidsramme: within 2 years
within 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
SF-12
Tidsramme: within 2 years
within 2 years
Work Limitations Scale
Tidsramme: within 2 years
within 2 years
Cuff integrity on imaging
Tidsramme: within 1 year post-operative
within 1 year post-operative
Strength
Tidsramme: within 2 years
within 2 years
Range of Motion
Tidsramme: within 2 years
within 2 years
American Shoulder and Elbow Surgeons (ASES) shoulder scale
Tidsramme: within 2 years
within 2 years
Shoulder and Pain Disability Index (SPADI)
Tidsramme: Within 2 years
Within 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

McMaster University

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation

Efterforskere

  • Ledende efterforsker: Joy C MacDermid, PhD, McMaster University, University of Western Ontario

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2006

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

5. august 2005

Først indsendt, der opfyldte QC-kriterier

5. august 2005

Først opslået (Skøn)

9. august 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCT-82335

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