NCT04031209

G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 275 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: —

Summary

This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.

Detailed description

The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DEVICE	G7 Acetabular System	All patients will receive G7 Acetabular System

Timeline

• Start date: 2020-01-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2019-07-24
• Last updated: 2024-12-18

Locations

7 sites across 1 country: South Korea

Regulatory

• FDA-regulated device study