Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
150 participants
OBSERVATIONAL
2025-10-13
2031-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum. Device components are made from durable materials that can withstand loads applied to the artificial hip joint during physical activity, are resistant to corrosion and fatigue, provide minimal friction and wear, and are biocompatible. Commonly used materials include cobalt chrome, commercially pure titanium, titanium alloy with aluminum and vanadium, ceramics, and ultrahigh molecular weight polyethylene.
Clinical studies have proven implant longevity in both cementless and cemented THA, offering patients effective long-term relief. In cementless THA, successful biological fixation is dependent on bony on-growth onto the surface of the prosthesis whereas, cemented fixation depends on a stable interface between prosthesis and cement and a solid mechanical bond between cement and bone. Ultimately, the goal of a THA is to bring the patients back to their normal routine without pain and stiffness. THA and hemiarthroplasty are both very successful procedures with an 84-97% patient satisfaction rate and an implant survival of over 90% after 10 years (THA) and implant survival of approximately 93% at 10 years (Hemiarthroplasty).
The Z1 Femoral Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The triple-tapered stem is designed for implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection.
The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is gritblasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjects implanted with the Z1 Femoral Hip System
Z1 Femoral Hip System
Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Z1 Femoral Hip System
Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hillary Overholser
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
OrthoCarolina/OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Orthopedic & Fracture Specialists
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Alexis Ready
Role: primary
Caleb Michalek
Role: backup
Jacquline Shelton
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMU2024-25H
Identifier Type: -
Identifier Source: org_study_id