Repair of Meniscal Injury
Conditions
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.
Interventions
DEVICEFibroFix Meniscal Scaffold
FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
Sponsors
Southmead Hospital, Bristol, UK
Magdeburg University Hospital, Germany
Brandenburg University Hospital, Germany
BundeswehrKrankenhaus Ulm, Germany
Universitat Autonoma de Barcelona
Centre Hospitalier du Luxembourg
Orthox Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance analysis of meniscal scaffold | At 12 months follow up | Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical criteria: quality of life | At 12 months follow up | Subjective assessments using internationally validated questionnaires EQ5D |
| Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications | At 12 months follow up | Incidence and severity of Adverse Events; incidence and severity of surgical complications |
| Clinical criteria: pain | At 12 months follow up | At 12 months follow up |
Outcome results
None listed