G7 Freedom Constrained Vivacit-E Liners

Rheumatoid Arthritis Clinical Trial

Official title: Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners

Status Enrolling by invitation

Clinical Trial Summary

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Clinical Trial Description

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the Kaplan-Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to the implant, instrumentation and/or procedure should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered. ;

Related Conditions & MeSH terms

• Avascular Necrosis
• Dislocation, Hip
• Femoral Neck Fractures
• Fractures, Bone
• Fractures, Ununited
• Hip Dislocation
• Hip Fractures
• Necrosis
• Non-Union Fracture
• Osteoarthritis, Hip
• Rheumatoid Arthritis
• Trochanteric Fractures

• NCT number: NCT05587244
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 8, 2023
• Completion date: December 2038