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New thumb implant aims to ease arthritis pain and restore grip

NCT ID NCT06546306

Disease control Sponsor: Keri Medical SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a new thumb joint replacement called the Touch® prosthesis in 216 adults with severe thumb osteoarthritis. The implant is designed to reduce pain and improve thumb mobility. Researchers will check how well it works and how safe it is over time, starting at 3 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Touch® dual mobility trapeziometacarpal prosthesis (a thumb joint replacement implant)
What this could lead to
If successful, this implant could offer a reliable option to reduce pain and restore thumb function for people with severe thumb osteoarthritis.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include surgery complications, implant failure, or ongoing pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

216 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Any type of population requiring a surgical procedure covered by the device indications and contraindications.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients (age ≥ 18 years), * Patients suffering from rhizarthrosis (I - IV based on the Dell classification), * Pain \>3 on the VAS scale, * Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis. Exclusion Criteria: * Pregnant women, * Patients with contraindications to surgery in general, * Patients suffering from Temporary Regional Pain Syndrome (TRPS), * Patients with a severe or chronic, local or systemic infection, * Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint, * Patients with bone demineralization or destruction that may affect the proper fixation of the implant, * Patients whose bone dimensions are incompatible with the implant dimensions, * The combination of the Touch® prosthesis with other components of another origin is not authorized, * Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel), * Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon, * Patient with scaphoid-trapezium-trapezoid (STT) arthritis, * Patient requiring revision of a trapeziometacarpal prosthesis, * Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, hand

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis thumb

Contacts and locations

Locations

  • Centre de la main du Pays d'Aix

    Aix-en-Provence, 13090, France

  • Clinic of Chataigneraie

    Beaumont, 63110, France

  • Medical Office Archimed

    Lesquin, 59810, France

  • Medical Office of Dr TCHURUKDICHIAN

    Dijon, 21000, France

  • Médipôle De Savoie

    Challes-les-Eaux, 73190, France

  • Orthopaedics and Trauma Surgery Practice

    Bezannes, 51430, France

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