Clinical trial NCT02205645: Initial Safety Evaluation of FibroFix™ Meniscus
Official title: A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Other Tear of Medial Meniscus, Current Injury
Keywords: medial
meniscus
scaffold
repair
tear
injury
Lead sponsor: Orthox Limited
Sponsor class: INDUSTRY
Collaborators: name: Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK
name: University of Bristol
First posted: 2014-07-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 7 years
measure: Functional assessment
timeFrame: 7 years
Other outcomes:
measure: Pain scores
timeFrame: 12m
measure: Functional assessment
timeFrame: 12m
measure: Post operative infection
timeFrame: 12m
Locations:
city: Bristol
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: University of Bristol
name: Ashley Blom, Professor
role: PRINCIPAL_INVESTIGATOR
References: