AMIC vs. MFx in the Ankle (NCT05741983) | Clinical Trial Compass
WithdrawnNot Applicable
AMIC vs. MFx in the Ankle
Stopped: unsatisfactory patient enrollment
United Kingdom0Started 2023-04-28
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tha…
What they're measuring
1
Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
Timeframe: difference from baseline to 12 months post-operative