NCT03308929

Prospective G7 Dual Mobility Total Hip PMCF

Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

Detailed description

This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.

Conditions

• Clinical Outcomes
• Functional Outcomes
• Radiological Outcomes
• Survivorship
• Safety

Interventions

Type	Name	Description
DEVICE	G7 Dual Mobility hip	Total hip arthroplasty and implantation of the G7 device

Timeline

• Start date: 2017-02-28
• Primary completion: 2027-07-01
• Completion: 2029-02-28
• First posted: 2017-10-13
• Last updated: 2025-06-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study