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Hip implant checked over 10 years: does it hold up?

NCT ID NCT02019849

Disease control Sponsor: Aesculap AG 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 100 people who received a Plasmafit® hip replacement device to see how well the implant survived over 10 years. Researchers checked implant survival, bone changes, and hip function using X-rays and clinical exams at 3 months, 1 year, 5 years, and 10 years after surgery. The goal was to confirm the device works safely 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
Plasmafit® Cup (hip replacement device)
What this could lead to
If the device performs well over 10 years, it could confirm that this hip implant is a reliable option for people needing total hip replacement.
What could go wrong
This is a small, single-arm follow-up study with no comparison group, so results may not apply to all patients. Long-term implant failure or complications like loosening or bone loss are 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

100 people

The number who actually took part.

Started

Jun 2012

Finished

Sep 2024

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

Specialist Clinical Centre

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: * Minimum age 18 years * Indication for cementless total hip arthroplasty * Patient consent for study participation * Physical and mental willingness to participate at clinical and radiological follow-up Exclusion Criteria: * Patient not available for follow-up * Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV * Tumor * Alcohol or drug abuse * Permanent cortisone therapy * Clinically relevant infection * Pregnancy or planned pregnancy * Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip * Acute fracture at the concerned hip * Patients needing a cemented hip arthroplasty

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As listed by the trial registrant

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

Total hip arthroplasty

Contacts and locations

Locations

  • Diakonie-Klinikum Stuttgart

    Stuttgart, Germany

  • Vulpius-Klinik Bad Rappenau

    Bad Rappenau, Germany

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