Non-Inferiority Trial of Intra-Articular Autologous Microfat and Platelet-Rich Plasma in Radiocarpal Osteoarthritis Versus Total Wrist Denervation

The primary objective of this study is to demonstrate the **non-inferiority** of the efficacy of an intra-articular injection of autologous microfat combined with platelet-rich plasma (PRP) in patients with radiocarpal osteoarthritis that is resistant to medical treatment. This will be evaluated by assessing pain reduction using the visual analog scale (VAS) at 6 months, compared to the established standard treatment of total wrist denervation. This objective is clinically relevant as it seeks to provide an alternative treatment option that may offer similar pain relief with potentially fewer complications or side effects associated with surgical denervation.

Secondary objectives include: - Assessing the safety of the study treatment at various time points (D7, M3, M6, M12) by monitoring adverse events and post-operative follow-up data. - Evaluating the non-inferiority of the study treatment compared to the reference treatment on secondary efficacy criteria. - Evaluating the effectiveness of the treatment at 3, 6, and 12 months. - Assessing patient satisfaction at D7, M3, M6, and M12. - Investigating the relationship between the characteristics of the injected products and clinical improvement, and describing the characteristics of responder and non-responder patients, with responders defined by a VAS improvement at 6 months exceeding a clinically significant difference of 14 points. - Evaluating the improvement of cartilage relaxation time on high-resolution T2 gradient echo and Turbo Spin Echo 3T MRI sequences at 6 months in patients receiving the study treatment.

The clinical trial focuses on patients diagnosed with **radiocarpal osteoarthritis** who have not responded to medical treatment. The study population includes both men and women aged 18 years and older. Participants are required to have symptomatic wrist osteoarthritis, characterized by pain of 40 mm or more on the visual analog scale (VAS 0-100 mm), potentially accompanied by a loss of strength and/or wrist mobility, which affects daily activities and quality of life. The condition must be confirmed through radiographic and arthroscopic evidence, with specific joint involvement and changes equivalent to a grade 3 on the Kellgren and Lawrence classification. The trial does not involve a vulnerable population. Participants must have failed medical treatment for at least one year, including analgesics, NSAIDs, orthosis, physiotherapy, and possibly intra-articular injections. Women of childbearing age are required to have a negative pregnancy test, and all participants must use reliable contraception. The sponsor has not provided information regarding the total number of participants in the trial.

The clinical trial is designed to evaluate the efficacy of an **intra-articular injection** of autologous microfat combined with autologous platelet-enriched plasma in the treatment of **radiocarpal osteoarthritis**. This study is a randomized, controlled, non-inferiority trial comparing the investigational treatment to total wrist denervation, which is the established standard treatment. The trial is expected to run from February 17, 2023, to February 17, 2028, with the primary endpoint being the measurement of pain intensity on the visual analog scale (VAS) at six months post-treatment.

Participants will be involved in the study for a maximum of one year, with the treatment period limited to a single administration of the investigational product. The study will include several key visits: an initial screening visit to confirm eligibility, baseline assessments, the administration of the investigational product, and follow-up visits at regular intervals to monitor efficacy and safety. The end-of-study visit will occur at the conclusion of the participant's involvement, where final assessments will be conducted.

Inclusion criteria require participants to be men or women aged 18 years or older, with symptomatic wrist osteoarthritis characterized by pain of at least 40 mm on the VAS, and radiographic evidence of the condition. Participants must have experienced a failure of medical treatment for at least one year. Exclusion criteria are not specified in the provided data. Participants may be withdrawn from the study if they experience adverse events that necessitate discontinuation, fail to comply with study procedures, or withdraw consent.

The investigational product, a mixture of microfat and platelet-rich plasma, is administered via intra-articular injection. The maximum daily and total dose is 4 mL. The trial is categorized as a Phase 4 clinical trial, indicating it is conducted after the product has been authorized for use. The study aims to demonstrate that the investigational treatment is not inferior to the standard treatment in terms of pain reduction, as measured by the VAS at six months.

The clinical trial involves the administration of an **experimental medication** known as MICROFAT 2 mL AND PLATELET RICH PLASMA HUMAN 2 mL MIXTURE. This medication is formulated as a **suspension for injection** and is intended for **intraarticular use**. The active substances in this mixture include **platelet concentrate** and **autologous microfat**. The platelet concentrate is derived from blood, while the autologous microfat is derived from other structurally diverse sources. The maximum daily and total dose of the mixture is 4 mL, administered in a single treatment session. The treatment period is limited to one day, and the administration is performed under controlled clinical conditions to ensure participant safety and compliance.

In this study, the experimental treatment is compared against a **standard-of-care therapy**, which is total wrist denervation, a recognized treatment for radiocarpal osteoarthritis. The trial is designed as a randomized controlled non-inferiority trial to evaluate the efficacy of the experimental treatment in comparison to the standard treatment. The primary objective is to assess the reduction in pain, as measured by the visual analog scale (VAS), at six months post-treatment. Participant compliance and response to treatment are monitored throughout the study to ensure accurate and reliable data collection.

The efficacy of the intra-articular injection of autologous microfat combined with autologous platelet-enriched plasma in the treatment of radiocarpal osteoarthritis will be assessed in this clinical trial. The primary endpoint for evaluating efficacy is the reduction in pain intensity, which will be measured using the **visual analog scale (VAS)** at 6 months post-treatment. This scale ranges from 0 to 100 mm, with higher scores indicating greater pain intensity. The trial aims to demonstrate the non-inferiority of this treatment compared to the established standard treatment of total wrist denervation. The efficacy assessment will focus on the comparison of pain reduction between the two treatment groups at the specified timepoint.