Status:

COMPLETED

A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.

Lead Sponsor:

University of Calgary

Collaborating Sponsors:

Workers' Compensation Board, Alberta

Canadian Orthopaedic Foundation

Conditions:

Rotator Cuff Tear

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rot...

Detailed Description

Rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's qua...

Eligibility Criteria

Inclusion

  • Patients with unremitting pain in the affected shoulder who have failed conservative treatment for at least 3 months
  • Weakness of rotator cuff (MRC grades 4-, 4 or 4+)
  • Positive diagnostic imaging on the affected shoulder indicating a full-thickness rotator cuff tear which may include arthrogram, ultrasound or MRI
  • Age \> 18 years
  • English speaking

Exclusion

  • A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
  • Previous surgery to the affected shoulder

Key Trial Info

Start Date :

March 1 1999

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2005

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT00251147

Start Date

March 1 1999

End Date

October 1 2005

Last Update

January 17 2008

Active Locations (4)

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Page 1 of 1 (4 locations)

1

University of Calgary Sport Medicine Centre

Calgary, Alberta, Canada, T2N 1N4

2

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3W7

3

Fowler Kennedy Sport Medicine Centre

London, Ontario, Canada, N6A 3K7

4

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, Canada, M4Y 1H1