Overview
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).
Description
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.
Eligibility
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
