Initial Safety Evaluation of FibroFix™ Meniscus

NCT ID: NCT02205645

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-10-17

Brief Summary

Initial evaluation of safety and performance of 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

Conditions

Other Tear of Medial Meniscus, Current Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FibroFix™ Meniscus scaffold

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK

UNKNOWN

Sponsor Role: collaborator

University of Bristol

OTHER

Sponsor Role: collaborator

Orthox Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Blom, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Bristol

Locations

Southmead Hospital

Bristol, , United Kingdom

Countries

United Kingdom

Other Identifiers

ORX/2014/FM01

Identifier Type: -

Identifier Source: org_study_id