Contact information
Type
Scientific
Primary contact
Dr Joy Christine MacDermid
ORCID ID
Contact details
McMaster University
School of Rehabilitation Science
IAHS Room 403
1400 Main Street West
Hamilton
Ontario
L8S 1C7
Canada
+1 905 525 9140 ext. 22524
macderj@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00128076
Protocol/serial number
MCT-82335
Study information
Scientific title
All-arthroscopic versus mini-open repair of small or moderate sized rotator cuff tears: a randomised controlled trial using conventional and expertise-based designs
Acronym
MvA RCT
Study hypothesis
To compare the effectiveness of all-arthroscopic to mini-open rotator cuff repair to improve the quality of life, as measured by the Western Ontario Rotator Cuff (WORC) Index, in patients with a small or medium-sized rotator cuff tear.
Ethics approval
1. Research Ethics Board of McMaster University approved on the 20th June 2006 (ref: 06-234)
2. Research Ethics Board of St. Josephs Healthcare approved on the 19th June 2006 (ref: 06-2680)
3. Office of Research Ethics of University of Western Ontario approved on the 8th May 2008 (ref: 12445)
4. Research Ethics Board of Sunnybrook & Womens College Health Science Centres approved on the 22nd January 2006 (ref: 082-2003)
5. Office of Medical Bioethics of University of Calgary approved on the 12th December 2005 (ref: 18559)
6. Health Research Ethics Board of University of Alberta approved on the 22nd June 2007 (ref: 6772)
7. Fraser Health Research Ethics Board approved on the 16th November 2007 (ref: FHREB 2006.062)
Study design
Multicentre, randomised, double blind (subject, outcomes assessor), parallel assignment, efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Shoulder pain, rotator cuff tear
Intervention
Mini-open rotator cuff repair surgery versus all-arthroscopic rotator cuff repair surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Quality of life based on the validated self report assessment tool Western Ontario Rotator Cuff index (WORC), measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively.
Secondary outcome measures
1. Biological integrity of repair based on MRI, measured at baseline and 12 months post-operatively
2. Surgical complications monitoring, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
3. Adverse events reporting, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
4. Physical impairment assessments including:
4.1. Range of Motion (ROM) Assessment Scale, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
4.2. Strength (measured using a hand held dynamometer and scale), measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
4.3. Composite Impairment Score, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
5. Pain/Disability: Shoulder Pain and Disability Index (SPADI) pain scale self report, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
6. General health: 12-item Short Form health survey (SF-12), measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
7. Work limitations: measured using two self-report measures, measured at baseline, at 6 weeks, 3, 6, 12, 18 and 24 months post-operatively
Overall trial start date
01/08/2006
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female patients
2. Aged 18 - 75 years
3. Small (0 - 1 cm) or moderate sized (1 - 3 cm) full-thickness rotator cuff tears of supraspinatus and infraspinatus, as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
Pre-operative exclusion criteria:
1. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder
2. Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations
3. Major medical illness (life expectancy less then two years or unacceptably high operative risk)
4. Unable to speak or read English
5. Psychiatric illness that precludes informed consent
6. Unwilling to be followed for two years
Intra-operative exclusion criteria:
7. Large, massive, or irreparable cuff tears, extending into the subscapularis or teres minor which cannot be mobilised to the articular margin or repaired with both techniques
8. Teres minor or subscapularis tears
9. Inelastic and immobile tendon, which cannot be advanced to articular margin
10. Co-existing labral pathologies requiring repair with sutures (superior labrum anterior posterior [SLAP] II - IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release
MRI exclusion criteria:
11. History of head or eye injury involving metal fragments
12. Ever worked in a metal shop or been a soldier
13. Presence of implanted electrical device (such as a cardiac pacemaker)
14. Severe heart disease (including susceptibility to arrhythmias)
15. Metal braces on teeth
16. Pregnancy
17. Presence of intrauterine device
Recruitment start date
01/08/2006
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton, Ontario
L8S 1C7
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82335)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16529658
Publication citations
-
Protocol
MacDermid JC, Holtby R, Razmjou H, Bryant D, , 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, 7, 25, doi: 10.1186/1471-2474-7-25.