Initial Safety Evaluation of FibroFix™ Meniscus

Orthox

Status: Terminated

Conditions: Other Tear of Medial Meniscus, Current Injury

Treatments: Device: FibroFix™ Meniscus scaffold

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02205645

ORX/2014/FM01

Details and patient eligibility

About

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Full 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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

FibroFix™ Meniscus scaffold

Experimental group

Description:

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.

Treatment:

Device: FibroFix™ Meniscus scaffold