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Z1 Hip System: Post-Market Clinical Follow Up Study
Sponsor: Zimmer Biomet
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).
Official title: Multicenter, Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-10-13
Completion Date
2031-08
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
Z1 Femoral Hip System
Subjects who will be implanted with the Z1 Femoral Hip System in hemi-hip arthroplasty and primary total hip arthroplasty
Locations (2)
OrthoCarolina/OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Orthopedic & Fracture Specialists
Portland, Oregon, United States