AMIC vs. MFx in the Ankle
- Conditions
- MicrofractureOsteochondral Lesion of TalusChondral Defect
- Interventions
- Procedure: Microfracture (MFx)Device: Chondro-Gide®
- Registration Number
- NCT05741983
- Lead Sponsor
- Geistlich Pharma AG
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMIC® Microfracture (MFx) Bone Marrow Stimulation (Microfracture) with Chondro-Gide® AMIC® Chondro-Gide® Bone Marrow Stimulation (Microfracture) with Chondro-Gide® Microfracture (MFx) Microfracture (MFx) Microfracture alone
- Primary Outcome Measures
Name Time Method Manchester Oxford Foot Questionnaire (MOX-FQ) walking/standing subscale difference from baseline to 12 months post-operative The effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the the MOX-FQ from baseline to 12 months. Raw score values for the walking/standing part are between 0-28, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
- Secondary Outcome Measures
Name Time Method American Orthopaedic Foot and Ankle-Hind foot Score (AOFAS) change at 12, 24 and 60 months from baseline The AOFAS has been used as a tool to measure the functional outcome after foot and ankle surgery and is often regarded as an essential outcome measure for all clinical studies. The score ranges from 0 - 100, where higher scores mean better outcomes.
EuroQol-5 Dimensions 5 Level (EQ5D-5L) change at 12, 24 and 60 months from baseline EQ5D-5L has been shown to be responsive in detecting changes in patient health status after foot and ankle surgery. The EQ5D-5L is widely used as a general health status measures for a wide variety of conditions and enables comparisons of health-related quality of life between different conditions. A summary index is derived from the patients answers, by applying a specific formula.
Tegner activity scale (TAS) change at 12, 24 and 60 months from pre-symptomatic score The TAS determines a patient's activity level by grading their work and sports-based activity on a scale of 0 to 10. It is a one-item score and has proven its psychometric properties in knee surgery patients.
Foot Functioning Index (FFI) change at 12, 24 and 60 months from baseline The FFI measures a patient's function in terms of pain, disability, and activity restriction to assess the impact of foot pathology. The index is self-administered and consists of 23 items, each scored 0 - 10, divided into three sub-scales. Higher scores mean decreased function.
Safety endpoints through study completion, an average of 5 years Safety will be measured by freedom from device and procedure-related serious adverse events (SADEs) and all other Adverse Events (AEs) or Serious Adverse Events (SAEs) occurred.
Manchester Oxford Foot Questionnaire (MOX-FQ) total change at 12, 24 and 60 months from baseline The MOX-FQ is a commonly reported scoring system in the literature with proven acceptability, reliability and responsiveness for assessment of patients undergoing various foot and ankle surgeries. The total score consists of 3 subscales: Pain, Walking/ Standing and Social interaction. Raw score values for the total score are between 0-64, where higher score mean a worse outcome. Raw scores are converted to a metric (0-100).
Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score change at 24 and 60 months from baseline The MOCART score was originally designed for evaluation of the cartilage in the knee, after procedures like microfracturing, and has a broad use to assess AMIC® in talus. The score is based on nine radiologic variables; degree of repair and defect filling, integration to border tissue, surface and structure of repair tissue, subchondral lamina and bone, adhesions and synovitis. The Score ranges from 0 - 100, where higher scores mean a better outcome.
Trial Locations
- Locations (1)
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom