NCT02736318终止1 期
Treatment of Osteochondral Lesion of Talus With Processed Osteochondral Allograft
TBF Genie Tissulaire4 个研究点 分布在 2 个国家目标入组 12 人开始时间: 2017年1月27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
- 12
- 试验地点
- 4
- 主要终点
- Determine the improvement in ankle function based on the OMAS at 24 months
研究概览
简要总结
Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.
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 50 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 50
- •Isolated osteochondral lesion of the talus due to trauma (fracture) or osteochondritis dissecans
- •Osteochondral lesion > Anderson Grade I (MRI)
- •1 to 3 cm2 lesion
- •Presence of disabling and clinically meaningful symptoms (subjective OMAS < 50)
- •Patient who has been treated previously for this lesion, except if this treatment consisted of autologous osteochondral grafting
- •No significant obesity (BMI < 30)
- •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.
- •Previous mosaicplasty treatment of this lesion
- •Fracture or bone defect or subchondral lesion without cartilage involvement, untreated osteonecrosis, collapse of talar dome
- •Presence of osteoarthritis, rheumatoid arthritis, excessive hindfoot deformity or any other condition of the talocural 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
- •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
Determine the improvement in ankle function based on the OMAS at 24 months
时间窗: 3 months, 6 months, 12 months, 18 months, 24 months
questionnaire
次要结局
- Clinical and functional improvement of the ankle by AOFAS score(3 months, 6 months, 12 months, 18 months,24 months)
- Impairment improvement by FASS ( foot and ankle severity score)(3 months, 6 months, 12 months, 18 months,24 months)
- Evaluate osteochondral graft integration with imaging(12 months, 18 months, 24 monts)
研究者
研究点 (4)
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