AMIC vs. MFx in the Ankle

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 28, 2023

Primary Completion Date

February 6, 2024

Study Completion Date

February 6, 2024

Conditions
Osteochondral Lesion of TalusChondral DefectMicrofracture
Interventions
PROCEDURE

Microfracture (MFx)

The ankle arthroscopy will be a standard procedure. The lesion will be identified, measured and prepared with curettage and soft tissue shaver. Preparation includes debridement of the unstable cartilage and in case of a chondral defect associated with a bone defect, the subchondral cyst is debrided. After debridement, the defect is classified and the lesion size is measured again.The microfracture will be performed with a microfracture awl. In cases of a chondral defect associated with a bone defect (osteochondral defect) the bone lesion must be treated concomitantly. Portal closure will be with steri-strips. All patients will follow the standard postoperative rehabilitation protocol including post op non-weight bearing and range of motion exercises for 6 weeks.

DEVICE

Chondro-Gide®

After the microfracture is performed and before the concomitant treatment of a bony lesion (if present), the defect size will be templated, and the membrane cut into its correct size. The joint is then drained and the membrane will be applied over the defect and stabilised with Fibrin glue. In cases of a osteochondral defect the bone lesion must be treated concomitantly. Once the bone defect has been treated, the Chondro-Gide® membrane is used to cover the site, and to support new cartilage tissue formation at the joint interface. Fluid will be reintroduced, and the stability of the membrane will be confirmed arthroscopically.

Trial Locations (1)

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Geistlich Pharma AG

INDUSTRY