The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
A cementless acetabular cup with ceramic liner for use in total hip replacement
A cementless acetabular cup with metal liner for use in total hip replacement
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
Cobalt metal ion levels in the blood at 2 years post surgery
Time frame: 2 years post-surgery
Kaplan-Meier survivorship calculations
Time frame: Annually
Oxford Hip Score
Time frame: 6 weeks, 6 months, and Annually
UCLA Score
Time frame: 6 weeks, 6 months, and Annually
Pain Visual Analogue Scale
Time frame: 6 weeks, 6 months, and Annually
Harris Hip Score
Time frame: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Radiographic analysis
Time frame: 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Blood metal ion levels
Time frame: pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
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