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

A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus

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.

Study Overview

• Status: Withdrawn
• Conditions: Repair of Meniscal Injury
• Intervention / Treatment: Device: FibroFix Meniscal Scaffold

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FibroFix	Device: FibroFix Meniscal Scaffold; FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance analysis of meniscal scaffold	Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner)	At 12 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical criteria: quality of life	Subjective assessments using internationally validated questionnaires EQ5D	At 12 months follow up
Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications	Incidence and severity of Adverse Events; incidence and severity of surgical complications	At 12 months follow up
Clinical criteria: pain	At 12 months follow up	At 12 months follow up

Collaborators and Investigators

• Sponsor: Orthox Limited
• Collaborators: Universitat Autonoma de Barcelona; Centre Hospitalier du Luxembourg; Southmead Hospital, Bristol, UK; Magdeburg University Hospital, Germany; Brandenburg University Hospital, Germany; BundeswehrKrankenhaus Ulm, Germany

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ORX/2016/FM02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No