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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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)
Step 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
Step 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
Step 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 trial?

13 criteria

Must be at least 18 years old (men and women can participate)
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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
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  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 trial?

15 criteria

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

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Assistance Publique Hopitaux De Marseille
Marseille, France

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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.

What is already known about the treatment

Autologous Microfat with PRP
A combination therapy consisting of the patient's own processed fat tissue (microfat) mixed with platelet-rich plasma (PRP) that is injected directly into the wrist joint. This innovative treatment is being studied for radiocarpal osteoarthritis as an alternative to surgical denervation, utilizing the natural healing and regenerative properties of both fat tissue and concentrated platelets. The mechanism of action involves the release of growth factors and stem cells that can potentially reduce inflammation, promote tissue repair, and alleviate joint pain. The treatment is administered as a single intra-articular injection and represents a minimally invasive approach in orthopedic medicine.
Platelet-Rich Plasma (PRP)
A concentrated form of the patient's own blood platelets suspended in plasma, prepared through a specialized centrifugation process. This injectable treatment contains high levels of growth factors and bioactive proteins that stimulate tissue healing and reduce inflammation when administered directly into the affected joint. PRP is widely used in regenerative medicine and orthopedics, showing promising results in treating various musculoskeletal conditions, with its main advantage being the use of the body's own healing mechanisms without synthetic medications.

Investigated diseases

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.