NCT03456622

BC Study of G7 Cup and Compatible Femoral Stems

A Prospective, Observational, Multi-centre, Cohort Study of the G7™Acetabular System Used With Compatible Femoral Stems in Patients With Degenerative Disease of the Hip

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective , observational, multi-centre, cohort study of the G7™ Acetabular System used with compatible femoral stems in patients with degenerative disease of the hip. The study will be enrolled onto Beyond Compliance.

Detailed description

The UK Beyond Compliance is a joint effort between implant manufacturers, implanting surgeons adopting our products, and the Beyond Compliance Advisory Group, all of whom are looking to ensure the safe and stepwise introduction of new or modified implants to the market in the interest of patients. The G7 Acetabular Cup System is Biomet multi-bearing acetabular platform with a wide range of acetabular shell options recently launched. There is a need to provide evidence on the safety and performance of this cup to support the product in different markets. The purpose of this multicenter study is to assess the clinical performance of the G7 acetabular system under standard condition of use. The data will help Biomet to gain 3A ODEP rating in 4 years and up to 10 year rating

Conditions

• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis

Timeline

• Start date: 2015-11-01
• Primary completion: 2029-06-01
• Completion: 2030-12-01
• First posted: 2018-03-07
• Last updated: 2025-11-25

Locations

1 site across 1 country: United Kingdom