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Pyrocarbon implants under the microscope: will they stand the test of time?

NCT ID NCT04137237

Disease control Sponsor: Stryker Trauma and Extremities 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is following 417 people who received pyrocarbon implants in their hand or wrist to see how well the implants perform over time. Researchers are measuring hand function using a standard questionnaire and tracking patient satisfaction and any complications. The goal is to confirm the implants are safe and effective in everyday use.

What this could mean

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

Active substance
Pyrocarbon hand and wrist implants
What this could lead to
If successful, this could confirm that pyrocarbon implants are a safe and effective option for improving hand and wrist function after surgery.
What could go wrong
This is an observational follow-up study, not a controlled trial. Results may not apply to all patients, and implant-related complications or need for revision surgery remain possible.

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 417 people

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

Started

Nov 2019

Expected to finish

Jan 2033

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

417 patients will be enrolled (About 50 to 80 per implant type). Prospective patients: screening and surgery should occur after the First site initiation visit. "Ambispective" patients: * Screening and surgery occurred before the date of the first site initiation visit, * Follow-up visits (at least the last two) must be prospective (i.e: must occur after the date of the first site initiation visit), * Inclusions of consecutive patients, * Minimum available data must be available for each completed visit.

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: * 18 years or older at the time he/she receives the information and signs the informed consent (when applicable as per local regulatory requirements), * Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee, * Willing and able to comply with the requirements of the study protocol, * For prospective inclusion: considered for treatment with one of PyC Hand/Wrist study implants (primary or revision surgery), * For "ambispective" inclusion: must have undergone a Hand or Wrist arthroplasty with a PyC Hand/Wrist study implant before the date of first site initiation visit, * Follow-up visits (at least the last two) must be prospective, * Patient must have complete information available for each completed visit Exclusion Criteria: * Patient pertaining to one of the categories referred to as "vulnerable population" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as "particularly vulnerable persons" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA), * Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times), * Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)

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As listed by the trial registrant

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

Orthopedics

How to take part

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

  1. The places running it

    4 sites in 2 countries. 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

  • Clinique du Parc

    RECRUITING

    Lyon, 69006, France

  • Espace Médical Vauban

    RECRUITING

    Paris, 75007, France

  • Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique

    RECRUITING

    Saint-Herblain, 44800, France

  • Orthopedic Surgeon (Dr. med. Dietmar Bignion)

    RECRUITING

    Bern, 3011, Switzerland

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