Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
|ClinicalTrials.gov Identifier: NCT01246895|
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment|
|Knee Injuries||Device: Microfracture with BST-CarGel Device: Microfracture without BST-CarGel|
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)
|Study Type :||Observational|
|Actual Enrollment :||67 participants|
|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)|
|Study Start Date :||March 2011|
|Primary Completion Date :||February 2014|
|Study Completion Date :||March 2014|
Microfracture with BST-CarGel
|Device: Microfracture with BST-CarGel|
Microfracture without BST-CarGel
|Device: Microfracture without BST-CarGel|
- Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI. [ Time Frame: 5 years ]Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).
- Repair Tissue Quality (T2 MRI) [ Time Frame: 5 years ]Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.
- Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C) [ Time Frame: 5 years ]The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. A higher score indicates a better health state improvement.
- The Number of Participants With Adverse Events Until 5 Years [ Time Frame: 5 years ]Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.
- Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire. [ Time Frame: 1 and 5 years ]SF-36 v2 includes 2 aggregate measures—Physical and Mental components—derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246895
|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|
|Canada, Nova Scotia|
|Orthopaedic and Sport Medicine Clinic of Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 4M2|
|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|
|Cirugia Ortopedica y Traumatologia, Medicina del Deporte|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital Universitario La Paz|
|Principal Investigator:||William Stanish, M.D||Orthopaedic and Sport Medicine - Dalhousie University|