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New thumb implant aims to beat standard surgery for arthritis pain

NCT ID NCT07178223

Disease control Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether replacing the arthritic thumb base joint with a dual-mobility implant provides better pain relief during activity than standard non-implant surgeries. 90 participants will receive the implant and be compared to 90 similar patients from an earlier trial. Researchers will track pain, hand function, and complications for up to 10 years.

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 thumb joint prosthesis (implant)
What this could lead to
If successful, this could offer a surgical option that provides better long-term pain relief and hand strength for people with thumb base osteoarthritis.
What could go wrong
This is a single-arm study with external controls, not a randomized trial, so results may be less reliable. Implant risks include loosening, dislocation, or infection.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2038

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Osteoarthritis in the thumb base. Radiological Eaton class 1-3 (Ladd et al. 2015). * Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test. The inclusion criteria are identical to those of the control population. Exclusion Criteria: * Rheumatoid arthritis. * Ongoing infection in the hand or wrist. * History of gout or pseudogout in the hand. * Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * Chronic pain syndrome / centralized pain. * Intra-articular corticosteroid injection in the affected joint within 3 months. -Eaton Littler class 4 (symptomatic STT joint osteoarthritis). The previously described exclusion criteria are identical to those of the control population. In addition patients with severe deformation of the trapezium, to the extent that it is not possible to place a prosthetic cup, will be excluded.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, hand

As listed by the trial registrant

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

Osteoarthritis of the CMC-1 joint

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Handkirurgiska kliniken Södersjukhuset

    RECRUITING

    Stockholm, 11883, Sweden