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New hip implant under study for safety and performance

NCT ID NCT07104279

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study is checking how well the Z1 Femoral Hip System works and how safe it is for people who need hip replacement surgery. About 150 adults with hip problems like arthritis or fractures will be followed for 2 years. The main goal is to see how many implants are still in place without needing removal or revision.

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 300 people

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

Started

Oct 2025

Expected to finish

Aug 2031

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

The study population should consist of up to 300 subjects implanted with the Z1 Femoral Hip System in hemi or total hip arthroplasty, according to the approved indications. Inclusion and exclusion criteria are based on the indications and contraindications defined in the IFU for the Z1 Femoral Hip System.

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 at least 18 years old and skeletally mature * Patient is physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol, including all scheduled study evaluations * Patient, or the patient's legally authorized representative, is willing and able to participate in the Informed Consent process and provide their consent * Independent of study participation, patient is a candidate and qualifies for primary total hip or hemi-arthroplasty based on physical exam and medical history including at least one of the following: * Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases * Acute traumatic fracture of the femoral head or neck * Avascular necrosis (AVN) of the femoral head Exclusion Criteria: * Revision arthroplasty * Acute, chronic, local, or systemic infection(s) * Severe muscular, neural, or vascular diseases that endanger the limb(s) 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. cobalt, chromium, nickel, etc.) * Local bone tumors and/or cysts * Patient has any condition that would, in the Investigator's opinion, place the patient at undue risk or interfere with the study * Any vulnerable subject: * a prisoner * a patient known to be pregnant * mentally incompetent or unable to understand what participation in the study entails * a known substance abuser

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Conditions

The condition(s) this trial relates to.

avascular necrosis of femoral head, primary, 1 familial avascular necrosis of femoral head femoral neck fracture hip fracture osteoarthritis osteoarthritis, hip

As listed by the trial registrant

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

Acute traumatic fracture of the femoral head or neck Avascular necrosis of the femoral head Hip osteoarthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. 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

  • Anderson Orthopaedic/Anderson Orthopaedic Research Institute

    NOT_YET_RECRUITING

    Alexandria, Virginia, 22308, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • OrthoCarolina/OrthoCarolina Research Institute

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Orthopedic & Fracture Specialists

    RECRUITING

    Portland, Oregon, 97225, United States

More trials for these conditions

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