Status:
COMPLETED
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
Lead Sponsor:
Piramal Healthcare Canada Ltd
Conditions:
Knee Injuries
Eligibility:
All Genders
18-55 years
Brief Summary
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, t...
Detailed Description
Cartilage repair currently remains a problematic orthopedic concern with no effective solution. The development of new surgical techniques or therapies is critical in meeting this medical need. Clini...
Eligibility Criteria
Inclusion
- The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period
- The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF)
Exclusion
- The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
- The subject did not complete 12 month follow-up period
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01246895
Start Date
March 1 2011
End Date
March 1 2014
Last Update
January 24 2018
Active Locations (16)
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1
University of Calgary Sports Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
2
Simon Fraser Orthopaedic Fund, Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
3
Joint Preservation Centre of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
4
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4