Condition category
Musculoskeletal Diseases
Date applied
05/06/2008
Date assigned
05/06/2008
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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. Joseph’s 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 & Women’s 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

http://www.mcmaster.ca/

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

  1. 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.

Additional files

Editorial Notes