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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05501743
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact Alice MAYOLY
Phone 0413429283
Email alice.mayoly@ap-hm.fr
Status Recruiting
Phase Phase 2
Start date February 17, 2023
Completion date June 2026

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