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Z1 Hip System: Post-Market Clinical Follow Up Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Zimmer Biomet

Record History

  1. Primary endpoint(s) modified Enrollment increased: 150 → 300 participants · Trial arms changed: 1 → 2 · Study sites: 2 to 4 · 1 morev5 Show 4 more changesShow less
    • Enrollment increased: 150 → 300 participants
    • Trial arms changed: 1 → 2
    • Study sites: 2 to 4
    • Secondary endpoints: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2025 to Oct 13, 2025 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2025 to Oct 13, 2025
    • Site details revised at 2 of 2 sites
  3. Start date: Aug 2025 to Sep 2025 Site contacts updated at 1 of 2 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  4. Study sites: 0 to 2v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Zimmer Biomet
83 trials monitored
See 1 trial at risk
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
Trial Details
NCT Number NCT07104279
Lead Sponsor Zimmer Biomet
Conditions Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck, Avascular Necrosis of the Femoral Head
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov