Z1 Hip System: Post-Market Clinical Follow Up Study

This study is looking at the Z1 Femoral Hip System, a device used in hip replacement surgeries. It's for people who have hip osteoarthritis, a broken hip bone (acute traumatic fracture of the femoral head or neck), or a condition where bone tissue dies due to lack of blood supply (avascular necrosis of the femoral head). The main goal is to see how safe and effective the Z1 Femoral Hip System is for two years after surgery. Researchers will track how well the implant stays in place and if there are any problems, complications, or additional surgeries needed. You can join if you are at least 18 years old and willing to follow the study plan.

Study design: This is an observational study, meaning researchers will watch and collect information from about 150 participants who receive the Z1 Femoral Hip System as part of their standard care.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for two years after their surgery to assess the implant's survival and any complications.

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Z1 Hip System: Post-Market Clinical Follow Up Study

Recruiting

Not specifiedAges 18+Observational

Zimmer Biomet

~300 participants

Updated 2026-08-27 on ClinicalTrials.gov

What's tested:Z1 Femoral Hip System

At a glance

Recruiting sites

3 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

2 Year Primary Outcome (Cohort 0)

Measured over 2 years post-operative

+1 more outcome measured

Conditions

Hip Osteoarthritis

Acute Traumatic Fracture of the Femoral Head or Neck

Avascular Necrosis of the Femoral Head

Where it's being run

4 sites across 4 states

North Carolina1

Ohio1

Oregon1

Virginia1

Study leadership

Hillary Overholser · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

Taylor Rowe

[email protected]

980-259-2813

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

2 Year Primary Outcome (Cohort 0)2 years post-operative
The primary endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure. Cohort 1
2 Year Primary Outcome (Cohort 1)2 years post-operative
The primary performance endpoint is the assessment of the HOOS JR, specifically the within-patient change from baseline to 2-years post-op. The mean change from baseline will be compared against a minimal clinically important difference (MCID) of 9.46 points.

Trialytics