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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 16
- 主要终点
- Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P
- •The subject did not complete 12 month follow-up period
结局指标
主要结局
Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.
时间窗: 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)
时间窗: 5 years
Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.
次要结局
- Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)(5 years)
- The Number of Participants With Adverse Events Until 5 Years(5 years)