Status:
UNKNOWN
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
DePuy Orthopaedics
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid i...
Detailed Description
Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patien...
Eligibility Criteria
Inclusion
- Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).
Exclusion
- Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
- Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
- Inability of the surgeon to repair the tear with less than 1cm of medialization,
- Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
- Active joint or systemic infection,
- Significant muscle paralysis of the shoulder girdle,
- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand the English language
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00182299
Start Date
September 1 2003
End Date
April 1 2008
Last Update
April 20 2007
Active Locations (1)
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1
The University of Western Ontario
London, Ontario, Canada, N6G 1H1