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New hip resurfacing device tracked for 10 years in 150 patients

NCT ID NCT06775704

Disease control Sponsor: Medacta International 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study follows 150 people aged 18 to 65 who receive the ROMAX hip resurfacing system to treat hip arthritis or dysplasia. Researchers will track how long the implant lasts and how well the hip functions over 10 years. The goal is to monitor the device's safety and performance in real-world use.

What this could mean

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

Active substance
ROMAX hip resurfacing system (a medical device that resurfaces the hip joint)
What this could lead to
If successful, this could confirm that the ROMAX system is a safe and effective option for younger patients needing hip resurfacing, potentially delaying or avoiding a full hip replacement.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove superiority over other devices. The device may still fail over time, requiring 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 150 people

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

Started

Jul 2025

Expected to finish

Apr 2037

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

150 patients undergoing hip resurfacing surgery and receiving the ROMAX system will be recruited consecutively by the study investigator. All patients will be offered to join the CTMA subgroup until the number of 40 subjects is reached. Choosing not to participate in the CTMA subgroup will not prevent the patient from participating in the study.

Ages

18 to 65 years

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: * Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use. * Aged between 18 and 65 years at the time of surgery. * Ability and willingness to provide written informed consent for participation. Exclusion Criteria: * Active infection * BMI \> 40 * Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams. * Significantly deformed anatomy (at the surgeon's discretion) * Osteomalacia where the fixation of an uncemented implant is contraindicated * Active rheumatoid arthritis * Osteoporosis * Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated * Muscle atrophy or neuromuscular disease * Known allergy or hypersensitivity to the implant material * Any patient who cannot or does not wish to give informed consent to participate in the study * Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.

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Conditions

The condition(s) this trial relates to.

arthritic joint disease developmental dysplasia of the hip developmental dysplasia of the hip 1 Hip Dislocation, Congenital osteoarthritis, hip

As listed by the trial registrant

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

Arthritis hip Hip dysplasia, congenital

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

  • Centre Hospitalier Universitaire de Lille

    RECRUITING

    Lille, 59000, France

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