NCT02732873撤回不适用
A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Performance analysis of meniscal scaffold
研究概览
简要总结
The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.
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
- •The subject (or guardian, if appropriate) has signed and dated a specific informed consent form;
- •The subject is over the age of 18 and ≤55 years of age;
- •The subject is able to comply with the protocol-defined pre-operative procedures, the post-operative 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 implantation;
- •The peripheral meniscal rim must be present;
- •The subject has a functionally intact ACL (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
- •Subject is >55 years of age;
- •The subject has a functionally deficient ACL;
- •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 programme;
- •The subject has a diagnosis of 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;
- •Current or recent (<3 months) participation in another device or drug study.
结局指标
主要结局
Performance analysis of meniscal scaffold
时间窗: At 12 months follow up
Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner)
次要结局
- Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications(At 12 months follow up)
- Clinical criteria: pain(At 12 months follow up)
- Clinical criteria: quality of life(At 12 months follow up)
研究者
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