Follow-Up Study Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
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, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.
Focal Articular Cartilage Lesions on the Femoral Condyle
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||FOLLOW-UP STUDY EVALUATING THE LONG-TERM SAFETY AND EFFICACY OF BST-CarGel® AND MICROFRACTURE IN REPAIR OF FOCAL ARTICULAR CARTILAGE LESIONS ON THE FEMORAL CONDYLE (Extension Study of Protocols CG-CIP01-P & CG-CIP02-P)|
- Degree of filling of the lesion by repair tissue at 60 months through Magnetic Resonance Imaging of cartilage [ Time Frame: 60 months ] [ Designated as safety issue: No ]Degree of lesion filling and quality of tissue repair at 60 months through quantitative Magnetic Resonance Imaging of cartilage
- Knee-related pain, stiffness and function at 60 months (WOMAC parts A, B, C) [ Time Frame: 60 months ] [ Designated as safety issue: No ]Long-term safety and efficacy of treatment on knee pain, stiffness, functional ability, general health status and quality of life at 60 months ( WOMAC, parts A,B,C)
- Long-term safety at 60 months through the frequency and severity of Adverse Events [ Time Frame: 60 months ] [ Designated as safety issue: No ]Evaluate the long-term safety at 60 months through the frequency and severity of Adverse Events
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2014|
BST CarGel+ Microfracture
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.
Clinical data regarding the long-term durability of repair tissue resulting from cartilage repair techniques such as microfracture, autologous chondrocyte implantation or mosaicplasty is lacking. Only two studies, one comparative and one uncontrolled, have examined long-term repair outcomes (over 4 years). These studies reinforced the concept that further studies are needed to identify a technique or product that will lead to long-term clinical benefit through improved cartilage repair efficacy.
BST-CarGel® is a medical device derived from chitosan applied to a microfractured lesion and has been shown to promote the quantity and quality of cartilage repair tissue in animals. The efficacy and safety of BST-CarGel® is currently being evaluated in humans as compared to the standard of care treatment, microfracture, in a 12 month international study in Canada, Europe and Korea under Protocols CG-CIP01-P and CG-CIP02-P. When these protocols were designed and carried out, the BST-CarGel® technology belonged to BioSyntech Canada Inc. Afterwards, the technology was acquired by Piramal Healthcare (Canada) Ltd. which is now the owner of the technology and the sponsor for this Extension Study CG-C1P04.
This follow-up study will evaluate the long-term effects (5 yrs) of BST-CarGel® + microfracture and microfracture alone in subjects treated in the pivotal and sub-studies.
All eligible subjects (maximum 80) who were treated under Protocols CG-CIP01-P and CG-CIP02-P and completed the required 12 month follow-up period will be asked to participate in this follow-up study.
The stratification from Protocols CG-CIP01-P and CG-CIP02-P (investigational site and lesion type) will be retained for the purposes of the follow-up study, and all third parties such as the MRI central reading facility will remain blinded to the treatment received under Protocols CG-CIP01-P and CG-CIP02-P.
Comparisons between the two treatment groups will be performed.
The following assessments will be done annually at years 3 and/or 4 and 5 post -treatment under Protocols CG-CIP01-P and CG-CIP02-P in subjects treated with BST-CarGel + microfracture or microfracture alone:
- Analyses of tissue repair will be carried out based on the degree of lesion filling and quality of repair tissue using MRI
- The general health status of subjects will be captured in the case report form (CRF) and will include the subject's overall health status, treated knee status, adverse events (AEs) and concomitant medications.
- The assessment of the subject's knee pain, stiffness, functional ability and quality of life through self-assessment questionnaires (Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and short-form-36 (SF-36v2)
|University of Calgary Sports Medicine Centre|
|Calgary, Alberta, Canada, T2N 1N4|
|Canada, British Columbia|
|Simon Fraser Orthopaedic Fund, Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Joint Preservation Centre of British Columbia|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Pan Am Clinic|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Oakville Trafalgar Memorial Hospital|
|Oakville, Ontario, Canada, L6J 3L7|
|Sports Medicine Center, Carleton University|
|Ottawa, Ontario, Canada, K1S 5B6|
|Sunnybrook Health Sciences Centre, Orthopaedics Research Office|
|Toronto, Ontario, Canada, M4N 3M5|
|Hospital Sacré-Coeur de Montréal|
|Montreal, Quebec, Canada, H4J 1C5|
|Québec, Quebec, Canada, G1J 1Z4|
|Hôpital Charles LeMoyne, Unité d'investigation non invasive|
|Québec, Quebec, Canada, J4V 2H1|
|FREMAP Centro de Prevención y Rehabilitatión|
|Majadahonda, Madrid, Spain|
|Hospital Clinic i Provincial de Barcelona|
|Barcelona, Spain, 08036|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital Universitario La Paz|
|Principal Investigator:||William Stanish, M.D||Orthopaedic and Sport Medicine - Dalhousie University|