The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pain (visual analogue scale;VAS)
研究概览
简要总结
Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not limited to more than one (1) lesion and the lesion that had been treated with microfracture or mosaicplasty but failed.
详细描述
Patients who qualify for this trial and who are interested in participating will be consented using an Institutional Review Board (IRB) approved Informed Consent. Once a patient has signed the Informed Consent Form he/she is considered enrolled in the trial. If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.
Clinical trial eligibility should be determined by confirmation that the patient meets the criteria included in the Protocol. Standard arthroscopic technique should be used to fully assess the joint and determine if the chondral or osteochondral defect is appropriate for inclusion in the study. Through arthroscopic examination after initial debridement, the investigator should use his best judgment to estimate the size of the lesion, and the number of BiCRI to be applied.
Plain radiographs and MRI prior to 6-month (inclusive) visit will be performed according to routine clinical practice; however, 12-month and 24-monthpostoperative images should be done for study outcome evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age between 16~65 (inclusive) years old presenting with either symptomatic chondral or osteochondral lesion of knee requiring primary surgical intervention. The lesions may include but not limited to following conditions:
- •multiple lesions
- •lesion that had been treated with microfracture or mosaicplasty but failed.
- •The index lesion is ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4
- •Willing and able to consent in wiring to participate in the study
排除标准
- •1. Rheumatoid arthritis and other inflammatory arthritis
- •The index cartilage lesion requires more than 3 (exclusive) implants
- •Skeletally immature (epiphyses are not closed based on x-ray)
- •Concomitant comorbidities
- •Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively
- •Pregnancy or breast feeding
- •Patient is actively participating in another medical device, drug, or biologic investigation (active defines as within the last 30 days prior to signing the consent form)
- •Any condition that is not suitable to participate in the study based on the physician's judgement
结局指标
主要结局
Pain (visual analogue scale;VAS)
时间窗: 24 months after operation
Pain (visual analogue scale;VAS) compare to baseline
International Knee Documentation Committee-2000 Subjective Knee Evaluation
时间窗: 24 months after operation
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
时间窗: 24 months after operation
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
International Knee Documentation Committee-2000 Knee Examination Form
时间窗: 24 months after operation
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 24 months after operation
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
次要结局
- International Knee Documentation Committee-2000 Subjective Knee Evaluation(12 months after operation)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(12 months after operation)
- Pain (visual analogue scale;VAS)(12 months after operation)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale(12 months after operation)
- International Knee Documentation Committee-2000 Knee Examination Form(12 months after operation)