Z1 Hip System: Post-Market Clinical Follow Up Study

NCT07104279 | Recruiting FDA Device

• 1 other identifier: CMU2024-25H
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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

Keywords

total hip arthroplasty; total hip replacement; osteoarthritis; hemiarthroplasty; partial hip replacement

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  2 years post-operative

Secondary Outcomes (2)

• HOOS Jr

  5 years post-operative

• Survivorship

  2 Years post-operative

Other Outcomes (2)

• Exploratory Outcome: EuroQol 5 Dimensions (EQ-5D)

  5 Years Postoperative

• Exploratory Outcome: Patient Satisfaction

  5 years postoperative

Study Arms (2)

Cohort 0

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

Device: Z1 Femoral Hip System

Cohort 1

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

Device: Z1 Femoral Hip System

Interventions

Z1 Femoral Hip System DEVICE

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

Cohort 0; Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

OrthoCarolina/OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Orthopedic & Fracture Specialists

Portland, Oregon, 97225, United States

RECRUITING

Anderson Orthopaedic/Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22308, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Taylor Rowe

CONTACT

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

Lynsey Boyle

CONTACT

lynsey.boyle@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (4)