Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

Not Applicable

Withdrawn

• Conditions: Repair of Meniscal Injury
• Interventions: Device: FibroFix Meniscal Scaffold

• Registration Number: NCT02732873
• Lead Sponsor: Orthox Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Study Start: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FibroFix	FibroFix Meniscal Scaffold	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Clinical criteria: quality of life	At 12 months follow up	Subjective assessments using internationally validated questionnaires EQ5D