NCT02732873WithdrawnNot Applicable
A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Orthox Limited
- Primary Endpoint
- Performance analysis of meniscal scaffold
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
FibroFix
Experimental
Intervention: FibroFix Meniscal Scaffold (Device)
Outcomes
Primary Outcomes
Performance analysis of meniscal scaffold
Time Frame: At 12 months follow up
Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner)
Secondary Outcomes
- Assessment of safety of meniscal scaffold - 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)
- Clinical criteria: quality of life(At 12 months follow up)
Investigators
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