NCT07104279 Z1 Hip System: Post-Market Clinical Follow Up Study
| NCT ID | NCT07104279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Hip Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-10-13 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Hillary Overholser
STUDY DIRECTOR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT07104279 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07104279 currently recruiting?
Yes, NCT07104279 is actively recruiting participants. Contact the research team at Taylor.Rowe@zimmerbiomet.com for enrollment information.
Where is the NCT07104279 trial being conducted?
This trial is being conducted at Charlotte, United States, Portland, United States.
Who is sponsoring the NCT07104279 clinical trial?
NCT07104279 is sponsored by Zimmer Biomet. The principal investigator is Hillary Overholser at Zimmer Biomet. The trial plans to enroll 150 participants.