Z1 Hip System: Post-Market Clinical Follow Up Study

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).

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	150 participants
Start Date	2025-10-13
Primary Completion	2028-08 (estimated)
Study Completion	2031-08 (estimated)
Updated on ClinicalTrials.gov	2025-11-10