Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
Launched by PIRAMAL HEALTHCARE CANADA LTD · Apr 12, 2006
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
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.
This Canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. A total of 80 subjects, 40 subjects in each of the two groups (BST-CarGel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. The subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. However, a...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Between 18 and 55 years of age
- • Focal articular cartilage lesion on the medial femoral condyle
- • Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
- • Stable knee
- Exclusion Criteria:
- • Multiple lesions or kissing lesions
- • Clinically relevant compartment malalignment (\> 5 degrees)
- • Undergone ligament treatments in the affected knee within 2 years prior to trial
- • Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
- • Previous surgical cartilage treatments in the affected knee in the last 12 months
About Piramal Healthcare Canada Ltd
Piramal Healthcare Canada Ltd. is a leading biopharmaceutical company dedicated to advancing healthcare solutions through innovative research and development. As a subsidiary of Piramal Enterprises, the organization leverages its extensive expertise in drug development and commercialization to address unmet medical needs across various therapeutic areas. Committed to improving patient outcomes, Piramal Healthcare Canada Ltd. conducts rigorous clinical trials that adhere to the highest standards of regulatory compliance and ethical practice. With a focus on collaboration and scientific excellence, the company strives to deliver safe and effective therapies that enhance the quality of life for patients in Canada and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Greenfield Park, Quebec, Canada
Seoul, , Korea, Republic Of
Barcelona, , Spain
Seoul, Jongno Gu, Korea, Republic Of
Calgary, Alberta, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Quebec, , Canada
Seoul, , Korea, Republic Of
Gijon, Asturias, Spain
Majadahonda, Madrid, Spain
Madrid, , Spain
Madrid, , Spain
Patients applied
Trial Officials
William Stanish, MD
Principal Investigator
Orthopaedic and Sport Medicine - Dalhousie University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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