Initial Safety Evaluation of FibroFix™ Meniscus

Not Applicable

Terminated

• Conditions: Other Tear of Medial Meniscus, Current Injury
• Interventions: Device: FibroFix™ Meniscus scaffold

• Registration Number: NCT02205645
• Lead Sponsor: Orthox Limited

Brief Summary

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2015-04
• Status Verified: 2017-04
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FibroFix™ Meniscus scaffold	FibroFix™ Meniscus scaffold	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.

Primary Outcome Measures

Name	Time	Method
Safety	12 months	Number of participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Safety	7 years	Number of participants with Adverse Events
Functional assessment	7 years	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

Trial Locations

Locations (1)

Southmead Hospital; 🇬🇧 Bristol, United Kingdom