Initial Safety Evaluation of FibroFix™ Meniscus

NCT02205645 | Terminated

• 1 other identifier: ORX/2014/FM01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold

Conditions

Other Tear of Medial Meniscus, Current Injury

Keywords

medial; meniscus; scaffold; repair; tear; injury

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of participants with Adverse Events

  12 months

Secondary Outcomes (2)

• Safety

  7 years

• Functional assessment

  7 years

Other Outcomes (3)

• Pain scores

  12m

• Functional assessment

  12m

• Post operative infection

  12m

Study Arms (1)

FibroFix™ Meniscus scaffold

EXPERIMENTAL

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

Interventions

FibroFix™ Meniscus scaffold 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.

FibroFix™ Meniscus scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthox Limited: lead
• Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK: collaborator
• University of Bristol: collaborator

Study Sites (1)

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Lacerations; Wounds and Injuries

Study Officials

• Ashley Blom, Professor

  University of Bristol

  PRINCIPAL INVESTIGATOR

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: July 23, 2014
• First Posted: July 31, 2014
• Study Start: April 1, 2015
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: March 13, 2019

Record last verified: 2017-04

Locations

GB (1)