Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair (REKREATE)

Orthox

Status

Withdrawn

Conditions

Repair of Meniscal Injury

Treatments

Device: FibroFix Meniscal Scaffold

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02732873

ORX/2016/FM02

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 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 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.