Z1 Hip System: Post-Market Clinical Follow Up Study

NCT07104279 | Recruiting FDA Device

• 1 other identifier: CMU2024-25H
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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-hip arthroplasty and primary total hip arthroplasty. 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).

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 (1)

• 2 Year Survivorship

  The absence of removal of the study device will be evaluated using 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.

  2 years post-operative

Secondary Outcomes (1)

• HOOS JR

  5 years post-operative

Study Arms (1)

Subjects implanted with the Z1 Femoral Hip System

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

Subjects implanted with the Z1 Femoral Hip System

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 150 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 (2)

OrthoCarolina/OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

RECRUITING

Orthopedic & Fracture Specialists

Portland, Oregon, 97225, United States

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: November 10, 2025

Record last verified: 2025-11

Locations

US (2)