NCT03266874

G7 BiSpherical Acetabular Shell PMCF Study

Prospective Multicenter Observational Evaluation of the Use of the G7 BiSpherical Acetabular Shell

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

Detailed description

The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was developed to provide an additional surgical option for patients in need of a total hip replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while reducing pain. This study is a multicenter, prospective, non-randomized, non-controlled post market surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators. 140-175 implants will be included into the study. Each site will be allowed to enroll 35 patients. All potential study subjects will be required to participate in the Informed Consent Process. The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical efficacy measured by overall pain and function, quality of life data and radiographic evaluation.

Conditions

• Rheumatoid Arthritis
• Osteoarthritis
• Noninflammatory Degenerative Joint Disease
• Avascular Necrosis
• Correction of Functional Deformity
• Non-Union Fracture
• Femoral Neck Fractures
• Trochanteric Fractures

Timeline

• Start date: 2017-12-10
• Primary completion: 2029-12-01
• Completion: 2031-12-01
• First posted: 2017-08-30
• Last updated: 2025-06-25

Locations

5 sites across 4 countries: France, Germany, Netherlands, Switzerland