RecruitingNCT07104279

Z1 Hip System: Post-Market Clinical Follow Up Study

Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System


Sponsor

Zimmer Biomet

Enrollment

150 participants

Start Date

Oct 13, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Z1 Femoral Hip System for people with acute traumatic fracture of the femoral head or neck, avascular necrosis of the femoral head, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZ1 Femoral Hip System

Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty


Locations(2)

OrthoCarolina/OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Orthopedic & Fracture Specialists

Portland, Oregon, United States

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NCT07104279


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