Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

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

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
• 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

Exclusion Criteria:

• 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