Other Tear of Medial Meniscus, Current Injury
Conditions
Keywords
medial, meniscus, scaffold, repair, tear, injury
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
Interventions
DEVICEFibroFix™ Meniscus scaffold
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.
Sponsors
Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK
University of Bristol
Orthox Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 months | Number of participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 12m | Assessments will be made using recognized and validated tools: Tegner index, Lysholm score, International Knee Documentation Committee (IKDC) score, VAS scale |
| Functional assessment | 12m | 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 |
| Post operative infection | 12m | Diagnosis of infection will be made on clinical grounds. If infection is diagnosed, a confirmatory bacterial culture will be collected and analysed locally. Assessment will include the patient, tissues around the wound and the wound itself. |
Countries
United Kingdom
Outcome results
None listed