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Can a cementless hip implant last? study tracks the SMS femoral stem

NCT ID NCT06640764

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 08, 2026 · Last updated Oct 09, 2026 · Updated 1 time

Summary

Researchers are studying the SMS femoral stem, a cementless hip implant made by Medacta, in people who need a total hip replacement because of osteoarthritis, traumatic arthritis, hip dysplasia, or avascular necrosis. The trial enrolls about 260 adults aged 18 to 75 and follows how long the implant stays in place and how well it restores hip function. Everyone in the study receives the same implant, and there is no comparison group.

What this could mean

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

Active substance
SMS femoral stem, a cementless hip implant used in total hip replacement
What this could lead to
If the implant holds up well, it could offer surgeons another reliable option for people who need a total hip replacement.
What could go wrong
The study follows patients for several years and has no comparison group, so it cannot prove the implant is better than other designs. Hip implants can loosen, wear, or need revision surgery over time.

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 260 people

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

Started

Sep 2024

Expected to finish

Sep 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

Patients suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem. Patients will be able to participate in other non-interventional research for the duration of the study.

Ages

18 to 85 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: * Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement. * Patient who will receive a Medacta SMS femoral stem. * Patient agrees to comply with the study requirements. * Patient has signed the consent form. * Patient is affiliated with a social security system. * Patient aged 18 to 75 years Exclusion Criteria: * Participation in biomedical research. * Minor patient. * Protected adult patient. * Vulnerable individuals as defined by Article L1121-6 of the Public Health Code. * Pregnant or breastfeeding women. * Patient unable to express their non-opposition. * Patient refusing the collection of their personal data. * Acute, systemic, or chronic infection. Skeletal immaturity. * Grossly deformed anatomy (at the surgeon's discretion). * Osteomalacia for which the fixation of an uncemented implant is contraindicated. * Patient suffering from active rheumatoid arthritis or osteoporosis. * Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated. * Patient suffering from muscle atrophy or neuromuscular disease. * Patient with an allergy to the implant material. * Any patient who cannot or does not wish to give their informed consent to participate in the study. * Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems. * Any contraindication mentioned in the instructions for use of the investigational medical device.

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Conditions

The condition(s) this trial relates to.

avascular necrosis of femoral head, primary, 1 developmental dysplasia of the hip familial avascular necrosis of femoral head osteoarthritis, hip

As listed by the trial registrant

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

Avascular necrosis of femur head Dysplasia of hip joint Hip osteoarthritis Traumatic arthritis of hip

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

  • Clinique de l'Union

    RECRUITING

    Saint-Jean, 31240, France

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