Clinical trial NCT05741983: AMIC vs. MFx in the Ankle
Official title: 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 (AMARTA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteochondral Lesion of Talus
Chondral Defect
Microfracture
Keywords: double-blind Randomised Controlled Trial (RCT)
Chondro-Gide®
AMIC®
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind RCT (Randomized Controlled Trial)
Primary purpose: TREATMENT

Brief 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).

Detailed 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 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

Primary outcomes:
measure: Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale
timeFrame: difference from baseline to 12 months post-operative
Secondary outcomes:
measure: Manchester Oxford Foot Questionnaire (MOX-FQ) total
timeFrame: change at 12, 24 and 60 months from baseline
measure: American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS)
timeFrame: change at 12, 24 and 60 months from baseline
measure: Foot Functioning Index (FFI)
timeFrame: change at 12, 24 and 60 months from baseline
measure: Tegner activity scale (TAS)
timeFrame: change at 12, 24 and 60 months from pre-symptomatic score
measure: EuroQol-5 Dimensions 5 Level (EQ5D-5L)
timeFrame: change at 12, 24 and 60 months from baseline
measure: Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score
timeFrame: change at 24 and 60 months from baseline
measure: Safety endpoints
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Geistlich Pharma AG
name: Despoina Natsiou Schmiady, Dr.
role: STUDY_DIRECTOR
affiliation: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
name: Torres Paulo, Mr.
role: PRINCIPAL_INVESTIGATOR
References: