unsatisfactory patient enrollment

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).

This clinical investigation compares 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). It is a prospective, double blind, single-centre, randomised controlled trial. The objective of this clinical investigation is to evaluate performance, effectiveness, and safety of AMIC® procedure versus Microfracture (MFx). The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the Manchester Oxford Foot Questionnaire (MOX-FQ) from baseline to 12 months. The secondary endpoints concern clinical safety and performance. Patients will be randomized into two groups: Microfracture alone (MFx) or Bone Marrow Stimulation (Microfracture) with Chondro-Gide® (AMIC®). The investigational device will be assessed within its intended use.

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

Patients will be blinded to the surgical procedure (with or without membrane). The outcome assessor who will complete the AOFAS and TAS will not be the physician who performed the surgery, the examiner is blinded to the treatment group to which the patient was allocated.