Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Repair of Meniscal Injury

Intervention / Treatment
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* Device: FibroFix Meniscal Scaffold


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FibroFix<br> | Device: FibroFix Meniscal Scaffold<br>* FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance analysis of meniscal scaffold | Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner) | At 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical criteria: quality of life | Subjective assessments using internationally validated questionnaires EQ5D | At 12 months follow up | 
| Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications | 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 | At 12 months follow up |