This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
The objectives of this study are to confirm the safety and performance of the Zimmer Maxera Cup mated with either a BIOLOX® delta or BIOLOX® OPTION femoral head when used in primary total hip arthroplasty. In total 250 patients will be enrolled into the study at up to 10 sites.All potential study subjects will be required to participate in the Informed Consent Process.
Study Type
OBSERVATIONAL
Enrollment
250
The Mater Hospital, Concord Hospital
Sydney, Australia
UZ Leuven
Pellenberg, Belgium
Center Maisonneuve-Rosemont Hospital
Montreal, Canada
Jokilaakson terveys oy
Jämsä, Finland
Centre Hospitalier de Perpignan
Perpignan, France
Reinier de Graaf Groep
Delft, Netherlands
Hospital Son Llatzer
Palma de Mallorca, Spain
Royal Liverpool and Broadgreen University Teaching Hospitals
Liverpool, United Kingdom
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time frame: 10 years post-surgery
Pain and functional performance based on the Harris Hip Score
Time frame: 10 years post-surgery
Pain and functional performance based on the UCLA Score
Time frame: 10 years post-surgery
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
Time frame: 10 years post-surgery
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Time frame: 10 years post-surgery
Safety based on eventual complications occurred including dislocations and revisions/removals
Time frame: 10 years post-surgery
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