All-arthroscopic or mini-open repair of a rotator cuff tear
| ISRCTN | ISRCTN66352753 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66352753 |
| ClinicalTrials.gov number | NCT00128076 |
| Secondary identifying numbers | MCT-82335 |
- Submission date
- 05/06/2008
- Registration date
- 05/06/2008
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joy Christine MacDermid
Scientific
Scientific
McMaster University
School of Rehabilitation Science
IAHS Room 403
1400 Main Street West
Hamilton, Ontario
L8S 1C7
Canada
| Phone | +1 905 525 9140 ext. 22524 |
|---|---|
| macderj@mcmaster.ca |
Study information
| Study design | Multicentre, randomised, double blind (subject, outcomes assessor), parallel assignment, efficacy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | MvA RCT |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | Shoulder pain, rotator cuff tear |
| Intervention | Mini-open rotator cuff repair surgery versus all-arthroscopic rotator cuff repair surgery. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
McMaster University
Hamilton, Ontario
L8S 1C7
Canada
L8S 1C7
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Website | http://www.mcmaster.ca/ |
|---|---|
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82335)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/03/2006 | Yes | No | |
| Results article | 01/10/2021 | 08/06/2022 | Yes | No |
Editorial Notes
08/06/2022: Publication reference added.
15/02/2019: No publications found, verifying study status with principal investigator.
