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Can a new hip implant stand the test of time?

NCT ID NCT02851992

Disease control Sponsor: Zimmer Biomet 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study follows about 300 people who receive a hip replacement using the GTS cementless stem, a type of implant that anchors to bone without cement. The goal is to see how well the implant performs over up to 10 years, measuring pain, function, and joint stability. Participants include adults with hip osteoarthritis or other hip conditions. The results will help determine if this implant offers lasting benefits for hip replacement patients.

What this could mean

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

Active substance
GTS cementless femoral stem (a hip replacement implant)
What this could lead to
If successful, this could confirm the GTS stem as a reliable long-term option for hip replacement, potentially improving pain and mobility for many patients.
What could go wrong
This is an observational study without a comparison group, so results may not prove the stem is better than others. Long-term follow-up may also have dropouts, and some patients may experience implant-related complications.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

303 people

The number who actually took part.

Started

Sep 2012

Finished

May 2025

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.

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: Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically * Primary osteoarthritis or secondary coxarthritis * Inflammation of the hip: rheumatoid arthritis, etc. * Femoral neck fracture * Avascular necroses of the femoral head * Sequelae from previous operations on the hip, osteotomies, etc. * Congenital hip dysplasia Additional inclusion criteria include: * 18 years of age or older * Subjects willing to return for follow-up evaluations * Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements) Exclusion Criteria: Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem Absolute contraindications include: * Local or systemic infections. * Severe muscular, neurological or vascular deficiencies of the extremity involved * Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.) * Concomitant disease likely to affect implant function * Allergy to any of the components of the implant * Patients weighing more than 110 kg Additional exclusion criteria: * Subjects unable to co-operate with and complete the study * Dementia and/or inability to understand and follow instructions * Neurological conditions affecting movement * Patient over 18 under law supervision

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Conditions

The condition(s) this trial relates to.

avascular necrosis of femoral head, primary, 1 developmental dysplasia of the hip femoral neck fracture osteoarthritis, hip rheumatoid arthritis

As listed by the trial registrant

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

Osteoarthritis, hip

More trials for these conditions

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