Multicenter Post-Market Clinical Follow-up Study of the Z1 Femoral Hip System for Hip Arthroplasty

What this Trial Is About

Researchers are evaluating the safety, performance, and clinical benefits of the Z1 Femoral Hip System in patients undergoing hemi-hip arthroplasty or primary total hip arthroplasty. This observational post-market clinical follow-up study focuses on implant survival at 2 years post-implantation and tracks complications, revisions, and adverse events related to the implant, instruments, or procedure. It also assesses patient-reported outcomes to understand functional performance and clinical benefits. The Z1 Femoral Hip System includes femoral stems designed for implantation into the proximal femur, compatible with femoral heads and adapters for total or hemi hip arthroplasty. The stems are made from titanium alloy, feature a wedge-shaped design with a titanium plasma coating and hydroxyapatite overcoat, and come in multiple sizes and offsets to fit various anatomies. The stems are used with specific Zimmer Biomet compatible components and are implanted using system-specific instruments. The procedure involves replacing the femoral head and sometimes the acetabulum, depending on the type of arthroplasty. Participants will be followed to record the implant’s survival, complications, and patient-reported outcomes over time. Evaluations include tracking revisions and adverse events, with a primary outcome measured at 2 years after surgery and secondary outcomes at 5 years using specific clinical scoring methods. The study collects data on safety and functional benefits to better understand the implant's performance in everyday use. The study is expected to continue through August 2031.

Z1 Hip System: Post-Market Clinical Follow Up Study