AMIC vs. MFx in the Ankle (AMARTA)
Osteochondral Lesion of Talus, Chondral Defect, Microfracture
About this trial
This is an interventional treatment trial for Osteochondral Lesion of Talus focused on measuring double-blind Randomised Controlled Trial (RCT), Chondro-Gide®, AMIC®
Eligibility Criteria
Inclusion criteria: Signed written informed consent Diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture Age of 18-65 years Subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up Exclusion criteria: Lesions smaller 1 square centimeters and greater than 4 square centimeters based on the MRI Malalignment which is not corrected prior to or as part of same surgery Established significant hindfoot arthritis Patients who are unable to have an MRI scan Chronic inflammatory arthritis or infectious arthritis History of autoimmune disease or immunodeficiency History of connective tissue disease Intra-articular steroid use within the 3 months prior to enrolment Other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment The patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone Pregnancy or lactation Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation Active infection of the index ankle Has been prescribed medication to treat osteoporosis Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions
Sites / Locations
- Freeman HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AMIC®
Microfracture (MFx)
Bone Marrow Stimulation (Microfracture) with Chondro-Gide®
Microfracture alone