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New silicone implant aims to restore hand function in arthritis patients

NCT ID NCT06546345

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a silicone implant called KeriFlex® to replace damaged finger joints in people with rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis. The goal is to see if the implant improves hand function and is safe over time. About 86 adults will receive the implant and be followed for at least 6 months.

What this could mean

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

Active substance
KeriFlex® silicone finger joint implant
What this could lead to
If successful, this implant could provide a safe and effective option to improve hand function and reduce pain in people with arthritis of the finger joints.
What could go wrong
This is a small, single-arm study without a comparison group, so results may not be definitive. As with any implant, risks include infection, implant failure, or need for revision surgery.

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

About 86 people

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

Started

Nov 2023

Expected to finish

Jan 2035

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 and presenting bone quality deemed satisfactory by the surgeon.

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 who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force. * Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis Exclusion Criteria: * Pregnant or breastfeeding women * Patients with an intellectual disability who cannot follow their surgeon's instructions * Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant * Patients with acute or chronic, local or systemic infections * Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation * Muscle loss, alteration or vascular deficiency in the affected finger * Patients with significant physical activity involving treated joint * Children, young growing patients with open epiphyses

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Conditions

The condition(s) this trial relates to.

osteoarthritis rheumatoid arthritis

As listed by the trial registrant

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

Degenerative arthritis Rheumatoid arthritis Traumatic arthritis

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHU Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • Clinic Lille Sud

    RECRUITING

    Lesquin, 59813, France

  • Institut aquitain de la main et du membre supérieur

    RECRUITING

    Pessac, 33600, France

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