G7 Dual Mobility With Vivacit-E or Longevity PMCF

Rheumatoid Arthritis Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05548972
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 20, 2023
• Completion date: August 2037