AMIC vs. MFx in the Ankle

This clinical investigation is a prospective, double blind, single-centre, randomised controlled trial comparing arthroscopic autologous matrix induced chondrogenesis (AMIC®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of AMIC® procedure versus microfracture (MFx).

Inclusion criteria:Signed written informed consentDiagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfractureAge of 18-65 yearsSubject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow upExclusion criteria:Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRIMalalignment which is not corrected prior to or as part of same surgeryEstablished significant hindfoot arthritisPatients who are unable to have an MRI scanChronic inflammatory arthritis or infectious arthritisHistory of autoimmune disease or immunodeficiencyHistory of connective tissue diseaseIntra-articular steroid use within the 3 months prior to enrolmentOther intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolmentThe patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolonePregnancy or lactationEnrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigationActive infection of the index ankleHas been prescribed medication to treat osteoporosisAny disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions