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Follow-up of the Z1 Femoral Hip System in people having hip replacement

Follows how the Z1 hip implant performs in adults having hip replacement surgery.

Key facts

Who runs it
Zimmer Biomet
Where
Alexandria, Charlotte, Cleveland, Platte City, and Portland, United StatesSee the 5 sites
Trial code
Registry title
Z1 Hip System: Post-Market Clinical Follow Up Study
Status
Recruiting
People taking part
300 people, planned
Started
13 Oct 2025
Expected to end
Aug 2031
Type of study
Observational, 2 groups
Treatments tested
  • Z1 Femoral Hip System
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need a first hip replacement, total or partial (hemi-arthroplasty), with the Z1 Femoral Hip System.

Age
18 years and older, with a fully grown skeleton.
Sex
All sexes.
Disease stage
Needs a first total or partial hip replacement because of at least one of these: advanced joint wear from degenerative, post-traumatic or rheumatic disease; a recent injury fracture of the femoral head or neck; or avascular necrosis (bone death) of the femoral head.
Earlier treatment
People who need a revision (a repeat hip replacement) cannot join.

Main reasons for not taking part

  • Any infection, local or throughout the body
  • Severe muscle, nerve or blood vessel disease that puts the leg at risk
  • Not enough bone, muscle or ligament to hold the implant
  • Allergy to the implant material, especially metals such as cobalt, chromium or nickel
  • Local bone tumors or cysts, known pregnancy, prisoners, known substance abuse

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 take part

  • Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible
  • Any concomitant diseases that can jeopardize the functioning and the success of the implant
  • Acute, chronic, local, or systemic infection(s)
  • Severe muscular, neural, or vascular diseases that endanger the limb(s) involved
  • Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)
  • Patient has any condition that would, in the Investigator's opinion, place the patient at undue risk or interfere with the study
  • Revision arthroplasty
  • Total or partial absence of the muscular or ligamentous apparatus
  • Local bone tumors and/or cysts
  • 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

Where in United States

  • Anderson Orthopaedic/Anderson Orthopaedic Research InstituteAlexandria, United StatesContact: Robert HopperTaking people
  • OrthoCarolina/OrthoCarolina Research InstituteCharlotte, United StatesContact: Alexis ReadyTaking people
  • Cleveland ClinicCleveland, United StatesContact: Laura StiegelTaking people
  • Mokan Orthopedic Research and ConsultingPlatte City, United StatesContact: Mandi PetersonTaking people
  • Orthopedic + Fracture SpecialistsPortland, United StatesContact: Jacquline SheltonTaking people

About the trial

What the trial wants to find out

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 full original descriptionShow less

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

The 2 groups in the trial

  • Cohort 0

    Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc.: AristoTech (Luckenwalde, Germany)

    Treatment: Z1 Femoral Hip System

  • Cohort 1

    Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc. (Warsaw, IN, USA)

    Treatment: Z1 Femoral Hip System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
Plain-language title
Follow-up of the Z1 Femoral Hip System in people having hip replacementGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
16 October 2026