Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair

NCT02732873 | Withdrawn DMC

• 1 other identifier: ORX/2016/FM02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Repair of Meniscal Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical criteria: quality of life

  At 12 months follow up

• Assessment of safety of meniscal scaffold - 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

Study Arms (1)

FibroFix

EXPERIMENTAL

Device: FibroFix Meniscal Scaffold

Interventions

FibroFix Meniscal Scaffold DEVICE

FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.

FibroFix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 11, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 12, 2022

Record last verified: 2022-10