Status:
COMPLETED
All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Conditions:
Shoulder Pain
Rotator Cuff Tear
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 tech...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00128076
Start Date
August 1 2006
End Date
December 1 2015
Last Update
May 27 2016
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
2
Walter Mackenzie Centre
Edmonton, Alberta, Canada, T6B 2G7
3
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3S 3W7
4
PanAm Clinic
Winnipeg, Manitoba, Canada, R3M 3E4