Prospective Clinical Study to Evaluate the Safety and Efficacy of Intraarticular Administration of Micro-grafts of Adipose Tissue (Adipo-micro-grafts) in the Treatment of Osteoarthritis of the Trapezium-metacarpal Joint (ADIPO_MICRO_GRAFTS_1)

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 26, 2022

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

Conditions
OsteoarthritisOsteoarthritis Thumbs
Interventions
PROCEDURE

adipose micro-grafts injection

Patients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe.

Trial Locations (1)

Unknown

Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona

All Listed Sponsors
lead

Azienda Ospedaliero, Universitaria Ospedali Riuniti

OTHER