NCT02430558终止1 期
Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial
TBF Genie Tissulaire0 个研究点目标入组 10 人开始时间: 2016年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 主要终点
- improvement of IKDC score
研究概览
简要总结
Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.
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
- •Male and female patients between the ages of 18 and 55
- •osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
- •Osteochondral lesion > grade II- ICRS
- •One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
- •Presence of disabling and clinically meaningful symptoms (subjective IKDC < 65, no improvement for 3 months)
- •No significant obesity (BMI < 30)
- •Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
- •Patient able to understand, sign and date the informed consent form
- •Patient affiliated with a national health insurance system or who is the beneficiary of such as system
- •Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.
排除标准
- •- Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- •Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
- •Excessive laxity or recurrent instability that could affect the score evaluation without concomitant ligamentoplasty
- •Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
- •Persons with cancer or a history of cancer
- •Persons deprived of their freedom by a judicial or administrative decision
- •Adults subject to legal protection measures or who are unable to provide their consent
结局指标
主要结局
improvement of IKDC score
时间窗: 18 months
次要结局
- recellularization of tissue (arthroscopy and histology)(18 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(18 months)
- integration of the tissue by imagery(18 months)
研究者
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