Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.