Hip OsteoarthritisNCT07104279
Z1 Hip System: Post-Market Clinical Follow Up Study
An observational study of Hip Osteoarthritis and Acute Traumatic Fracture of the Femoral Head or Neck, run by Zimmer Biomet at 5 sites in United States.
Trial 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- and primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck, Avascular Necrosis of the Femoral Head
- What is being tested?
- Z1 Femoral Hip System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Oct 2025to Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population should consist of up to 300 subjects implanted with the Z1 Femoral Hip System in hemi or total hip arthroplasty, according to the approved indications. Inclusion and exclusion criteria are based on the indications and contraindications defined in the IFU for the Z1 Femoral Hip System.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lynsey Boyle contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Anderson Orthopaedic/Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22308
Robert Hopper, 571-345-5877, rhopper@aori.org
Robert Sershon, MD
- Recruiting
OrthoCarolina/OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Alexis Ready, 704-323-3620, alexis.ready@orthocarolina.com
Caleb Michalek, 704.323.3698, caleb.michalek@orthocarolina.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Laura Stiegel, 216-442-5511, STIEGEL@ccf.org
Matthew Deren, MD
- Recruiting
Mokan Orthopedic Research and Consulting
Platte City, Missouri, 64079
Mandi Peterson, 816-674-1229, mandi@petersonhipandknee.com
Blake Peterson, MD
- Recruiting
Orthopedic & Fracture Specialists
Portland, Oregon, 97225
Jacquline Shelton, 503-214-5209, jacquline.shelton@OandFS.com
Elizabeth Lieberman, MD
About this study
Official title: Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
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- and primary total hip arthroplasty.
Cohort 0 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.
Read more
The secondary endpoints are defined by the functional performance and clinical benefits of the study device and are assessed by patient-reported clinical outcomes measures (PROMs)(Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)).
Cohort 1 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.
The key secondary safety 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.
Exploratory outcomes include:
- EuroQol 5 Dimensions (EQ-5D)
- Patient Satisfaction
- Radiographic outcomes, where available
Read the detailed description
Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relief pain and debilitating symptoms. A femoral stem component is used in conjunction with a femoral head component for the replacement of the proximal femur in total hip or hemi hip arthroplasty. THA now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications include osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN) and hip fractures. The surgical procedure consists in replacing the head of the femur and acetabulum (socket) with a prosthesis. Another type of hip arthroplasty is called Hemi arthroplasty, which does not include the replacement of the acetabulum.
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
- Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck, Avascular Necrosis of the Femoral Head
- Being tested
- Z1 Femoral Hip System
- Keywords
- total hip arthroplasty, total hip replacement, osteoarthritis, hemiarthroplasty, partial hip replacement
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z1 Femoral Hip SystemDevice
Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0 | Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc.: AristoTech (Luckenwalde, Germany) Receives: Device: Z1 Femoral Hip System | |
| Cohort 1 | Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc. (Warsaw, IN, USA) Receives: Device: Z1 Femoral Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Year Primary Outcome (Cohort 0)
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
Measured: 2 years post-operative
2 Year Primary Outcome (Cohort 1)
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.
Measured: 2 years post-operative
Secondary outcomes (2)
HOOS Jr
Cohort 0:
The functional performance and clinical benefits of the study device will be assessed by a patient-reported clinical outcomes measure (PROM)(HOOS JR).
Measured: 5 years post-operative
Survivorship
Cohort 1:
The key secondary safety 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. Each secondary endpoint will be followed out to 5 years.
Measured: 2 Years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start13 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104279
- Sponsor's protocol ID
- CMU2024-25H
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
- ClinicalTrials.gov ID
- NCT07104279
- Acronym / sponsor ID
- CMU2024-25H
- Conditions
- Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck, Avascular Necrosis of the Femoral Head
- Keywords
- total hip arthroplasty, total hip replacement, osteoarthritis, hemiarthroplasty, partial hip replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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- and primary total hip arthroplasty.
Cohort 0 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.
The secondary endpoints are defined by the functional performance and clinical benefits of the study device and are assessed by patient-reported clinical outcomes measures (PROMs)(Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)).
Cohort 1 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.
The key secondary safety 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.
Exploratory outcomes include:
- EuroQol 5 Dimensions (EQ-5D)
- Patient Satisfaction
- Radiographic outcomes, where available
Detailed description
Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relief pain and debilitating symptoms. A femoral stem component is used in conjunction with a femoral head component for the replacement of the proximal femur in total hip or hemi hip arthroplasty. THA now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications include osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN) and hip fractures. The surgical procedure consists in replacing the head of the femur and acetabulum (socket) with a prosthesis. Another type of hip arthroplasty is called Hemi arthroplasty, which does not include the replacement of the acetabulum.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 0 | – | Device: Z1 Femoral Hip SystemSubjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc.: AristoTech (Luckenwalde, Germany) |
| Cohort 1 | – | Device: Z1 Femoral Hip SystemSubjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc. (Warsaw, IN, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should consist of up to 300 subjects implanted with the Z1 Femoral Hip System in hemi or total hip arthroplasty, according to the approved indications. Inclusion and exclusion criteria are based on the indications and contraindications defined in the IFU for the Z1 Femoral Hip System.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z1 Femoral Hip SystemSubjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty | Device | Cohort 0, Cohort 1 |
Primary outcome
2 Year Primary Outcome (Cohort 0)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
HOOS Jr
Time frame: 5 years post-operative
Survivorship
Time frame: 2 Years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynsey Boyle contact
Hillary Overholser study director
Zimmer Biomet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Acute Traumatic Fracture of the Femoral Head or Neck, run by Zimmer Biomet at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Rowe (980-259-2813, Taylor.Rowe@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Year Primary Outcome (Cohort 0) (time frame: 2 years post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.