Initial Safety Evaluation of FibroFix™ Meniscus

Other Tear of Medial Meniscus, Current Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02205645
• Other study ID #: ORX/2014/FM01
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 17, 2017

Study information

• Verified date: April 2017
• Source: Orthox Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Other Tear of Medial Meniscus, Current Injury

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Southmead Hospital	Bristol

Sponsors (3)

Lead Sponsor	Collaborator
Orthox Limited	Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain scores	Assessments will be made using recognized and validated tools: Tegner index, Lysholm score, International Knee Documentation Committee (IKDC) score, VAS scale	12m
Other	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
Other	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
Primary	Safety	Number of participants with Adverse Events	12 months
Secondary	Safety	Number of participants with Adverse Events	7 years
Secondary	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