Clinical trial NCT02732873: Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair
Official title: A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Repair of Meniscal Injury
Lead sponsor: Orthox Limited
Sponsor class: INDUSTRY
Collaborators: name: Southmead Hospital, Bristol, UK
name: Magdeburg University Hospital, Germany
name: Brandenburg University Hospital, Germany
name: BundeswehrKrankenhaus Ulm, Germany
name: Universitat Autonoma de Barcelona
name: Centre Hospitalier du Luxembourg
First posted: 2016-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Performance analysis of meniscal scaffold
timeFrame: At 12 months follow up
Secondary outcomes:
measure: Clinical criteria: quality of life
timeFrame: At 12 months follow up
measure: Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications
timeFrame: At 12 months follow up
measure: Clinical criteria: pain
timeFrame: At 12 months follow up
Other outcomes:
Locations:
Study officials:
References: