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New hip stem tested for Long-Term stability

NCT ID NCT05848024

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 100 people who received a total hip replacement with a specific implant called AMIStem C. The main goal is to see how much the implant moves inside the bone over time, using special X-ray analysis. Researchers will also check how well patients recover and how long the implant lasts, up to 10 years after surgery.

What this could mean

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

Active substance
AMIStem C cemented femoral stem (hip implant)
What this could lead to
If successful, this could confirm that the AMIStem C stem is stable and durable for long-term hip replacement, potentially improving surgical outcomes.
What could go wrong
This is a small, single-center, non-randomized study with no control group, so results may not apply broadly. The primary outcome is based on imaging analysis, not direct patient benefit.
Why investors are watching

Medacta International is running a 100-patient study of its AMIStem H hip implant to see how well the stem stays fixed in the bone over 10 years. For a small company, a long-term readout on a core product can shape how surgeons view the implant's durability and how the company positions it against competitors.

If it works: If the study shows low stem migration and good functional scores at 10 years, Medacta can point to long-term stability as a selling point for AMIStem H. That evidence could support wider adoption of the implant in hip replacement procedures.

If it fails: If the implant shows high migration or many complications, surgeons may lose confidence in the product, and Medacta could face slower sales or pressure to redesign. Trials often fail to meet their goals, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

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

100 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Feb 2029

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 with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement and who will receive an AMIStem® C cemented femoral stem. Patients will be able to participate in other non-interventional research during 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.

The inclusion criteria are: 1. Patient with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head...) requiring the placement of a total hip prosthesis. 2. Patient who will receive an AMIStem® C cemented femoral stem. 3. Patient willing to comply with the study requirements 4. Patient who has signed the information letter agreeing to the processing of their data in the clinical evaluation 5. Patient affiliated to a social security system 6. Patients aged 18 to 85 years The criteria for non-inclusion are: 1. Participation in biomedical research 2. Minor patients 3. Protected adult patients 4. Vulnerable persons according to article L1121-6 of the Public Health Code 5. Pregnant or breastfeeding women 6. Patients unable to formulate their non-opposition 7. Patient refusing collection of personal data

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Conditions

The condition(s) this trial relates to.

arthritic joint disease avascular necrosis of femoral head, primary, 1 osteoarthritis, hip

As listed by the trial registrant

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

Total hip arthroplasty

Contacts and locations

Locations

  • Hôpital privé Arras Les Bonnettes

    Arras, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.