Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07104279

Z1 Hip System: Post-Market Clinical Follow Up Study

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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

Interventions

DEVICE

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