NCT01471236已完成不适用
Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 9
- 主要终点
- improvement in KOOS pain subscales
研究概览
简要总结
The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.
详细描述
Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 55 years
- •Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau
- •Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage.
- •Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters.
- •Primary or secondary articular cartilage repair.
- •Knee is stable or can be stabilized as a concomitant procedure.
- •Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
- •Signed informed consent.
- •Any misalignments should be fully corrected at the end of the operative procedure.
排除标准
- •Uncorrected axial misalignments >5° that cannot be corrected.
- •Patellar cartilage defects or pathology.
- •Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
- •Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
- •Active acute or chronic infection of the treated knee.
- •Inflammatory arthropathy or crystal-deposition arthropathy.
- •Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone.
- •Bony defect depth over 3 millimeters.
- •Body mass index >
- •Asymptomatic articular cartilage defects.
- •Bipolar articular cartilage defects.
- •Osteoarthritis of the operated knee.
- •Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy.
- •Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months
- •Any previous operation of cartilage treatment within the last 6 months
- •Patients who are sensitive to materials containing calcium carbonate or hyaluronate
- •Pregnant women, women who plan to become pregnant and breastfeeding women.
- •Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the patient's welfare.
- •Substance abuse or alcohol abuse.
- •Participation in another clinical trials in parallel to this study.
- •Type I diabetes.
- •Unable to undergo MRI or X-ray.
- •Any reasons making the patient a poor candidate in the opinion of the investigator.
研究组 & 干预措施
Agili-c bi-phasic implant
Experimental
mini-arthrotomy
干预措施: Agili-C Bi-phasic Implant (Device)
Agili-c bi-phasic implant
Experimental
mini-arthrotomy
干预措施: mini-arthrotomy (Procedure)
结局指标
主要结局
improvement in KOOS pain subscales
时间窗: 24 months
The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
次要结局
- KOOS total score(24 months)
研究者
研究点 (9)
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