Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
Southmead Hospital
Bristol, United Kingdom
Safety
Number of participants with Adverse Events
Time frame: 12 months
Safety
Number of participants with Adverse Events
Time frame: 7 years
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
Time frame: 7 years
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