Z1 Hip System: Post-Market Clinical Follow Up Study

Conditions

• Acute Traumatic Fracture of the Femoral Head or Neck
• Avascular Necrosis of the Femoral Head
• Hip Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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

Key Dates

First listed

Aug 5, 2025

Start date

Oct 13, 2025

Status verified

Aug 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2031

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Cohort 0
  Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc.: AristoTech (Luckenwalde, Germany)
• Arm: Cohort 1
  Subjects implanted with the Z1 Femoral Hip System manufactured by Zimmer, Inc. (Warsaw, IN, USA)

Primary Outcome Measure

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

Central Contacts

• Taylor Rowe
  980-259-2813
  [email protected]
• Lynsey Boyle
  [email protected]

Locations (4)

Find similar trials in Charlotte, NC

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