Initial Safety Evaluation of FibroFix™ Meniscus

A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Study Overview

• Status: Terminated
• Conditions: Other Tear of Medial Meniscus, Current Injury
• Intervention / Treatment: Device: FibroFix™ Meniscus scaffold

Detailed Description

The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal defect

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older 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
• The subject is able to comply with the protocol-defined preoperative procedures, the postoperative 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 repair
• The peripheral meniscal rim must be present
• The subject has a functionally intact 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:

• The subject has a functionally deficient anterior cruciate ligament
• 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 program
• The subject has a diagnosis of untreatable 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

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™ Meniscus scaffold; The test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.	Device: FibroFix™ Meniscus scaffold; The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus. The FibroFix™ Meniscus scaffold used in this study 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
Safety	Number of participants with Adverse Events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Number of participants with Adverse Events	7 years
Functional assessment	Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) Score and range of motion of knee	7 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Assessments will be made using recognized and validated tools: Tegner index, Lysholm score, International Knee Documentation Committee (IKDC) score, VAS scale	12m
Functional assessment	Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) score and range of motion of knee	12m
Post operative infection	Diagnosis of infection will be made on clinical grounds. If infection is diagnosed, a confirmatory bacterial culture will be collected and analysed locally. Assessment will include the patient, tissues around the wound and the wound itself.	12m

Collaborators and Investigators

• Sponsor: Orthox Limited
• Collaborators: University of Bristol; Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK
• Investigators: Principal Investigator: Ashley Blom, Professor, University of Bristol

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 17, 2017
• Study Completion (Actual): October 17, 2017

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: injury; meniscus; scaffold; repair; medial; tear
• Other Study ID Numbers: ORX/2014/FM01