AMARTA version 1.0
Research type
Research Study
Full 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)
IRAS ID
312660
Contact name
Paulo Torres
Contact email
Sponsor organisation
Geistlich Pharma AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 4 months, 31 days
Research summary
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 measure by the difference in the walking/standing-part score taken from the MOX-FQ from baseline to 12 month. 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®). Patients will be followed-up according to clinical routine 2 weeks, 3 months, and 1, 2 and 5 years after the surgery. Chondro-Gide® is a collagen membrane, which is manufactured according to a standardized and controlled process. Chondro-Gide® has a two-layer (bilayer) structure and consists of collagen without cross-linking or chemical additives. The Chondro-Gide® carries the CE mark and has been cleared for use in the European Union since 1999.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0344
Date of REC Opinion
15 Dec 2022
REC opinion
Further Information Favourable Opinion