Status:
TERMINATED
Initial Safety Evaluation of FibroFix™ Meniscus
Lead Sponsor:
Orthox Limited
Collaborating Sponsors:
Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK
University of Bristol
Conditions:
Other Tear of Medial Meniscus, Current Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02205645
Start Date
April 1 2015
End Date
October 17 2017
Last Update
March 13 2019
Active Locations (1)
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1
Southmead Hospital
Bristol, United Kingdom, BS10 5NB