Study of Autologous Microfat and Platelet-Rich Plasma Injection Compared to Wrist Denervation in Patients with Radiocarpal Osteoarthritis

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What is this study about?

This study focuses on treating radiocarpal osteoarthritis, a condition that causes pain and stiffness in the wrist joint where the forearm bones meet the small bones of the wrist. The study compares two different treatments: a new approach using an injection that combines a person’s own fat tissue (called autologous microfat) and platelet-rich plasma (called PRP) versus a standard surgical procedure called total wrist denervation, which involves cutting specific nerves to reduce pain.

The purpose is to determine if the injection treatment works as well as the standard surgical treatment for managing wrist pain. The injection mixture contains 2 milliliters of processed fat tissue and 2 milliliters of concentrated platelets, both taken from the patient’s own body. This mixture is injected directly into the affected wrist joint.

During the study, patients will receive either the injection treatment or undergo the surgical denervation procedure. The effects of both treatments will be monitored for six months, with special attention paid to how well they reduce pain. The injection treatment, if proven effective, could offer patients a less invasive alternative to surgery for treating painful wrist arthritis.

1 Initial evaluation and preparation

Your wrist pain and mobility will be evaluated using a visual analog scale (a tool to measure pain intensity from 0 to 100)

A medical professional will review your wrist X-rays and arthroscanner results to confirm radiocarpal osteoarthritis (joint damage in the wrist)

2 Group assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Receiving an injection of autologous microfat (fat tissue from your own body) combined with platelet-rich plasma (concentrated platelets from your blood)

Group 2: Receiving total wrist denervation (standard surgical procedure to reduce wrist pain)

3 Treatment administration

If assigned to Group 1: You will receive a single injection into your wrist joint containing 2 mL of microfat mixed with 2 mL of platelet-rich plasma

If assigned to Group 2: You will undergo the standard wrist denervation procedure

4 Follow-up period

Your pain levels will be monitored and measured using the same scale as before treatment

The main evaluation of treatment effectiveness will occur 6 months after the procedure

Additional assessments may include wrist strength testing using a special device called a Jamar dynamometer

5 Study completion

The study will conclude with a final evaluation of your wrist pain and function

Total participation time in the study will be 6 months from the treatment date

Who Can Join the Study?

Must be at least 18 years old (men and women can participate)
Must have wrist osteoarthritis with:
- Pain score of at least 40 on a 0-100 scale
- May have reduced hand strength or limited wrist movement affecting daily activities
- Condition must be confirmed by X-rays showing joint changes
- Must have tried standard medical treatments for at least one year, including:
  - Pain medications
  - Anti-inflammatory drugs
  - Wrist support brace
  - Physical therapy
  - Previous joint injections (if received)
Must sign an informed consent form agreeing to participate in the study
For women who can become pregnant:
- Must have a negative pregnancy test
- Must use reliable birth control during the study
Must be covered by a social security system

Who Cannot Join the Study?

Age below 18 or above 75 years
Previous surgery on the affected wrist
Presence of inflammatory arthritis (a condition where the immune system attacks the joints)
Active infection in the wrist area
Coagulation disorders (problems with blood clotting)
Current treatment with blood thinners
Pregnancy or breastfeeding
Known allergy to local anesthetics
Presence of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
Active cancer or ongoing cancer treatment
Inability to follow study procedures or attend follow-up visits
Participation in another clinical trial within the past 30 days
Severe psychiatric conditions that may interfere with the study
Platelet count below normal range (platelets are blood cells that help with clotting)
Uncontrolled diabetes

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Awazgqucug Pqkpfncy Hisrqmdu Dp Movucjffn	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	17.02.2023

Trial locations

Investigated drugs:

Autologous Microfat with Platelet-Rich Plasma (PRP)
This is a combination therapy where fat tissue and platelet-rich plasma are taken from the patient’s own body. The fat is processed into tiny particles (microfat), and blood is processed to concentrate the platelets. These are then combined and injected into the wrist joint. This treatment aims to reduce pain and inflammation in patients with wrist arthritis.

Total Wrist Denervation
This is a surgical procedure that involves cutting specific nerves around the wrist joint to reduce pain signals. It is considered the standard treatment for severe wrist arthritis when other treatments haven’t worked. The procedure aims to provide pain relief while maintaining wrist movement.

Investigated diseases:

Osteoarthritis

Radiocarpal Osteoarthritis – A degenerative joint disease affecting the wrist joint where the radius bone meets the first row of carpal bones. The condition involves gradual wearing down of the cartilage that cushions the joint surfaces between the radius and carpal bones. Over time, the smooth cartilage surface becomes rough and thin, leading to friction between bones during movement. The condition typically develops slowly and causes stiffness and reduced range of motion in the wrist. Common symptoms include pain during wrist movement, swelling around the joint, and a grinding sensation when moving the wrist.

Trial ID:

2024-516239-28-00

NCT ID:

NCT05501743

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Autologous Microfat and Platelet-Rich Plasma Injection Compared to Wrist Denervation in Patients with Radiocarpal Osteoarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?