NCT05501743

Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).

Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial. It is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.

Detailed description

The main objective is to demonstrate the non-inferiority of the efficacy of intra-articular injection of autologous microfat and PRP in patients suffering from radiocarpal osteoarthritis resistant to medical treatment on pain evaluated by the visual analog scale (VAS) at 6 months in comparison with total denervation of the wrist (reference treatment). Secondary objectives are: * To assess the safety of the study treatment at D7, M3, M6, M12, compared to the reference treatment group: Adverse events and post-operative follow-up data. * To assess the non-inferiority of the study treatment compared to the reference treatment on the secondary efficacy criteria. * Evaluate the effectiveness of the treatment under study. * Evaluate patient satisfaction. * To investigate the existence of a relationship between the characteristics of the injected products and the clinical improvement and to describe the characteristics of the responder and non-responder patients. The responder patient was characterized by an improvement of the VAS at 6 months superior to the minimal clinically significant difference fixed at 14 points. * To evaluate the improvement of cartilage relaxation time on high-resolution T2 gradient echo and Turbo Spin Echo 3T MRI sequences at 6 months in patients in the "study treatment" group.

Conditions

• Arthrosis

Interventions

Type	Name	Description
DRUG	Intra-articular injection of microfat and PRP	The treatment by intra-articular injection of autologous microfat and PRP will be performed during a half-day outpatient stay in the hand and limb repair surgery department at the Hôpital de la Timone. The total duration of the procedure is approximately 4 hours and includes 2 surgical times performed in the operating room and an intermediate waiting time for the patient in an outpatient room during the preparation of the experimental products.
PROCEDURE	Total denervation of the wrist	The surgical treatment by total denervation of the wrist will be performed during a one-day outpatient stay in the hand and limb surgery department at the Hôpital de la Timone. It will be performed under loco-regional anesthesia by axillary plexus block.

Timeline

• Start date: 2023-02-17
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2022-08-15
• Last updated: 2023-03-10

Locations

1 site across 1 country: France