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Hip implant Follow-Up study aims to confirm Long-Term safety

NCT ID NCT03396224

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracks 100 adults who need a hip replacement to see how well the Avenir cemented hip stem works and holds up over time. Participants have conditions like arthritis, hip fractures, or hip damage from past surgeries. The main goal is to measure how long the implant lasts without needing to be removed.

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

Nov 2015

Expected to finish

Nov 2030

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 who: * are in need of a primary total hip arthroplasty * receive the Avenir® Cemented Hip Stem and compatible femoral head and acetabular cup * meet all the inclusion criteria and none of the exclusion criteria

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: * Patient is 18 years of age minimum. * Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. Exclusion Criteria: * Patient is unwilling or unable to give consent, or to comply with the follow-up program. * Acute, chronic, local, or systemic infections. * Severe muscular, neural, or vascular diseases that endanger the limbs involved. * Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible. * Total or partial absence of the muscular or ligamentous apparatus. * Any concomitant diseases that can jeopardize the functioning and the success of the implant. * Allergy to the implanted material, especially to metal (e.g., stainless steel). * Local bone tumors and/or cysts. * Pregnancy * Skeletal immaturity * Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them. * Patients with plans to relocate during the study follow-up period. * For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.

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Conditions

The condition(s) this trial relates to.

avascular necrosis avascular necrosis of femoral head, primary, 1 developmental dysplasia of the hip familial avascular necrosis of femoral head femoral neck fracture Hip Dislocation, Congenital osteoarthritis osteoarthritis, hip

As listed by the trial registrant

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

Congenital hip dysplasia Femoral head necrosis Femoral neck fractures Osteotomies Post-traumatic osteoarthritis of hip Primary osteoarthritis Sequelae from previous hip surgery

Contacts and locations

Locations

  • Cliniques Universitaires St-Luc UCL

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Hopital Lapeyronie - Service Orthopédie

    Montpellier, Occitanie, 34295, France

  • Hôpital Gabriel Montpied - Service de chirurgie Orthopédique

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003, France

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