The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
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.
Study Type
OBSERVATIONAL
Enrollment
160
Cabinet du Dr. Miazzolo
Perpignan, France
Orthopädische Chirurgie Müchen OCM
Munich, Bavaria, Germany
Herzogin Elisabeth Hospital
Braunschweig, Lower Saxony, Germany
Reinier de Graaf Groep
Delft, Netherlands
Implant survivorship is assessed counting the number of implant revisions
Time frame: 10 years
Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire
Time frame: 10 years
Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire
Time frame: 10 years
Safety is assessed according to the number of complications which are collected via adverse event forms.
Time frame: 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orthoprax AG
Bern, Switzerland