Initial Safety Evaluation of FibroFix™ Meniscus

Study Overview
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Brief Summary
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Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Detailed Description
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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

Official Title
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A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects

Conditions
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Other Tear of Medial Meniscus, Current Injury

Intervention / Treatment
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* Device: FibroFix™ Meniscus 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 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

Ages Eligible for Study
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Minimum Age: 18 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™ Meniscus scaffold<br>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. | Device: FibroFix™ Meniscus scaffold<br>* The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus. The FibroFix™ Meniscus scaffold used in this study 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 |
| --- | --- | --- |
| Safety | Number of participants with Adverse Events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of participants with Adverse Events | 7 years | 
| Functional assessment | Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) Score and range of motion of knee | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medial, meniscus, repair, tear, injury, scaffold