NCT07104279 · Zimmer Biomet
Z1 Hip System: Post-Market Clinical Follow Up Study
What this study is about
The objectives of this study are to confirm the early to mid-term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty. The primary objective of this post market clinical follow-up (PMCF) study is the assessment of safety by recording and analyzing the survival of the implant system at 2 years post-implantation.
View original scientific description
The objectives of this study are to confirm the early to mid-term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty. The primary objective of this post market clinical follow-up (PMCF) study is the assessment of safety by recording and analyzing the survival of the implant system at 2 years post-implantation. Safety will also be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation, and/or procedure should be specified. The secondary objective is the assessment of functional performance and clinical benefits of the Z1 Femoral Hip System demonstrated by recording patient-reported clinical outcomes measures (PROMs).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 patient known to be pregnant
- mentally incompetent or unable to understand what participation in the study entails
- a known substance abuser
Where
- Charlotte, North Carolina
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations