NCT02036931

A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 162 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Detailed description

This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use. Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively. Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.

Conditions

• Noninflammatory Degenerative Joint Disease
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Metal on Polyethylene articulation	G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
DEVICE	Ceramic on Polyethylene articulation	G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
DEVICE	Ceramic on Ceramic articulation	G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY

Timeline

• Start date: 2013-03-01
• Primary completion: 2024-12-01
• Completion: 2025-05-01
• First posted: 2014-01-15
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

6 sites across 6 countries: United States, France, Germany, Ireland, Netherlands, Spain