NCT05548972

G7 Dual Mobility With Vivacit-E or Longevity PMCF

Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty

Detailed description

The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties. This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally. A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.

Conditions

• Hip Osteoarthritis
• Rheumatoid Arthritis
• Joint Diseases
• Avascular Necrosis
• Dislocation, Hip
• Femoral Neck Fractures
• Trochanteric Fractures
• Revision Surgeries

Interventions

Type	Name	Description
DEVICE	G7 Dual Mobility with Vivacit-E bearing	hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
DEVICE	G7 Dual Mobility Longevity bearing	hip arthroplasty with G7 Dual Mobility Longevity bearing

Timeline

• Start date: 2023-03-20
• Primary completion: 2037-01-01
• Completion: 2037-08-01
• First posted: 2022-09-22
• Last updated: 2025-06-15

Locations

10 sites across 4 countries: United States, Belgium, Italy, South Korea

Regulatory

• FDA-regulated device study