NCT02205645终止不适用
A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold
详细描述
The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject (or guardian, if appropriate) has signed and dated a specific informed consent form
- •The subject is over the age of 18
- •The subject is able to comply with the protocol-defined preoperative procedures, the postoperative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the investigator
- •The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect
- •The meniscal defect should represent 25% or more of the meniscus and be amenable to repair
- •The peripheral meniscal rim must be present
- •The subject has a functionally intact anterior cruciate ligament
- •Haemoglobin >9g/dL and platelet count >100,000/mm3 prior to Day 1
- •No contraindication to general anaesthetic
- •Female subjects of child-bearing potential: a negative urine pregnancy test
排除标准
- •The subject has a functionally deficient anterior cruciate ligament
- •The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation program
- •The subject has a diagnosis of untreatable Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint
- •Patients demonstrating an active local or systemic infection
- •Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Meniscus scaffold and clinical outcome.
- •The subject has a history of confirmed anaphylactoid reaction
- •The subject has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery
- •The subject has evidence of osteonecrosis of the involved knee
- •The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis
- •If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
研究组 & 干预措施
FibroFix™ Meniscus scaffold
Experimental
The test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
干预措施: FibroFix™ Meniscus scaffold (Device)
结局指标
主要结局
Safety
时间窗: 12 months
Number of participants with Adverse Events
次要结局
- Safety(7 years)
- Functional assessment(7 years)
研究者
研究点 (2)
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