AMIC vs. MFx in the Ankle (AMARTA)

Geistlich Pharma

Status: Withdrawn

Conditions: Chondral Defect; Microfracture; Osteochondral Lesion of Talus

Treatments: Device: Chondro-Gide®; Procedure: Microfracture (MFx)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05741983

13575-236

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

AMIC®

Experimental group

Description:

Bone Marrow Stimulation (Microfracture) with Chondro-Gide®

Treatment:

Procedure: Microfracture (MFx)

Device: Chondro-Gide®

Microfracture (MFx)

Active Comparator group

Description:

Microfracture alone

Treatment:

Procedure: Microfracture (MFx)