Osteochondral Lesion of Talus Clinical Trial
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)
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04475341 -
Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?
|
N/A | |
| Enrolling by invitation |
NCT03856021 -
Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
|
N/A | |
| Not yet recruiting |
NCT05476692 -
Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus
|
||
| Active, not recruiting |
NCT02345564 -
Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
|
N/A | |
| Active, not recruiting |
NCT01347892 -
DeNovo NT Ankle LDC Study
|
N/A | |
| Active, not recruiting |
NCT03750253 -
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
|
N/A | |
| Recruiting |
NCT06358807 -
Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus
|
N/A | |
| Completed |
NCT04194970 -
Monitoring of Weight Bearing Protocols Via Mobile Application and Pressure Sensors.
|
N/A | |
| Enrolling by invitation |
NCT02338375 -
Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell Product
|
Phase 0 | |
| Enrolling by invitation |
NCT04132076 -
Treatment Outcome After Ankle Joint Surgeries
|