RecruitingOBSERVATIONAL

Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

This study is comparing two ways to treat arthritis at the base of the thumb, known as rhizarthrosis. This condition often affects women over 50. Currently, a standard operation involves removing a small bone in the thumb (trapezectomy). However, new thumb joint replacements (arthroplasties) are also available. Researchers want to see if these newer joint replacements lead to better recovery compared to the traditional surgery. They will look at how well patients can use their thumb, their pain levels, and X-ray results over time. The goal is to discover which surgical method offers the best long-term results and quicker recovery for people with this type of arthritis.

At a glance

Status

Recruiting

Sponsor

Clinique Bizet

Enrolment target

Start

24 Nov 2023

Estimated completion

01 May 2027

Rhizarthrosis

What is this study about?

This study is looking into a common type of arthritis that affects the joint at the base of your thumb, where your thumb meets your wrist. This condition is called rhizarthrosis, and it can cause pain, stiffness, and make it hard to use your thumb properly. It's more common in women, especially after the age of 50, and can be influenced by things like your genes, hormones, and how much you use your hands for certain movements.

When other treatments like pain relief and splints haven't worked, surgery might be suggested. This study wants to compare two main types of surgery. One is called a trapezectomy, which is the standard operation where a small wrist bone at the base of your thumb is removed. The other is a newer treatment called arthroplasty, which involves replacing the affected joint with an artificial one, much like a hip or knee replacement.

Doctors want to understand if one of these surgeries is better than the other at helping people get back to normal activities, reducing pain, and improving how the thumb works. They will follow patients closely for a short time and then for a longer period to see the lasting effects of each surgery. This will help them decide which approach is most effective for people living with thumb arthritis.

Key takeaways

Compares two types of thumb arthritis surgery.
Looks at a standard bone removal versus a new joint replacement.
Aims for better patient recovery and long-term results.
Requires participants to be over 45 with persistent thumb pain.
Involves regular check-ups and X-rays after surgery.

Who may be eligible?

To join this study, you need to be at least 45 years old. You must have painful arthritis at the base of your thumb that hasn't gotten better with other treatments, like wearing a night splint for three months or having two injections in a year. You also need to be living in France and able to understand and answer survey questions on your own. You must be covered by a social security system and not already taking part in another clinical study.

There are also some reasons why you wouldn't be able to join. For example, if you are under 18 years old, if the bone at the base of your thumb is too small (less than 8mm), or if you are legally protected and not able to make your own decisions. You also can't join if you have a known allergy to the materials used for the joint replacement, have an infection in the area, or have skin problems like an unhealed wound. Pregnant or breastfeeding women also can't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 45 years old or older?
Does your thumb arthritis still cause pain, even after trying other treatments like splints and injections?
Are you living in France?
Are you able to speak English and understand and answer questions on your own?
Are you not currently part of any other medical study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive one of the two types of thumb surgery: either the traditional bone removal (trapezectomy) or the newer joint replacement (arthroplasty). You won't get to choose which one you receive. After your surgery, doctors will regularly check how you're recovering. This will involve appointments where they look at how well your thumb is working, ask you about your pain and daily activities, and take X-rays. These check-ups will happen frequently in the first three months, and then less often for a medium and long period after that to see the lasting effects of the surgery. The total duration of your participation, including all follow-up appointments, will be explained to you by the study team.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as contributing to medical knowledge that might help future patients with thumb arthritis. You would receive surgery from experienced surgeons and have close follow-up care. However, as with any surgery, there are potential risks, including those associated with anaesthesia, infection, bleeding, and potential complications specific to each surgical procedure. The study will aim to identify any superior outcomes, but there's no guarantee that participating will personally lead to a better result for you compared to standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinique BIZET
Verified postcode
Paris, France· Recruiting

Common questions

What is rhizarthrosis?

It's a type of arthritis affecting the joint at the very bottom of your thumb, where it connects to your wrist.

What's the difference between the two surgeries being compared?

One surgery removes a small bone at the base of your thumb (trapezectomy), and the other replaces the joint with an artificial one (arthroplasty).

Will I get to choose which surgery I have?

No, if you join the study, you will be randomly assigned to one of the two surgery groups, like drawing lots.

Why are they doing this study?

They want to find out which surgical method leads to better recovery and long-term results for people with thumb arthritis.

How long will I need to be in the study?

You will have close follow-up for at least three months after surgery, and then for longer periods to check your recovery and results.

How to find out more

Bouchra BENKESSOU, PM

b.benkessou@hexagone-santé-paris.fr 0764486016 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.