Recruiting

Z1 Femoral Hip System

Sponsor:

Zimmer Biomet

Code:

NCT07104279

Conditions

Hip Osteoarthritis

Acute Traumatic Fracture of the Femoral Head or Neck

Avascular Necrosis of the Femoral Head

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Z1 Femoral Hip System

Study Details

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- 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

Conditions

Hip Osteoarthritis

Acute Traumatic Fracture of the Femoral Head or Neck

Avascular Necrosis of the Femoral Head

Study ID

NCT07104279

Start date

Oct 13, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 0

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

Cohort 1

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

Interventions

Z1 Femoral Hip System

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

Primary outcome measure

  • 2 Year Primary Outcome (Cohort 0) [ Time Frame: 2 years post-operative ]
  • 2 Year Primary Outcome (Cohort 1) [ Time Frame: 2 years post-operative ]

Central Contacts and Locations

Central contacts

Taylor Rowe

980-259-2813Taylor.Rowe@zimmerbiomet.com

Lynsey Boyle

lynsey.boyle@zimmerbiomet.com

Locations

OrthoCarolina/OrthoCarolina Research Institute

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Alexis Ready

704-323-3620alexis.ready@orthocarolina.com

Caleb Michalek

704.323.3698caleb.michalek@orthocarolina.com

Principal Investigator:

John Masonis, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Stiegel

216-442-5511STIEGEL@ccf.org

Principal Investigator:

Matthew Deren, MD

Orthopedic & Fracture Specialists

Recruiting

Portland, Oregon, United States, 97225

Contacts

Jacquline Shelton

503-214-5209jacquline.shelton@OandFS.com

Principal Investigator:

Elizabeth Lieberman, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • total hip arthroplasty
  • total hip replacement
  • osteoarthritis
  • hemiarthroplasty
  • partial hip replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2026-08-27.