The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
A cementless acetabular cup with metal liner for use in total hip replacement
Ospedale Riuniti Di Bergamo
Bergamo, Italy
Royal Orthopaedic Hospital
Birmingham, United Kingdom
Kaplan-Meier survivorship calculated at the 5 year time point.
Time frame: 5 years
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
Time frame: Annually
Harris Hip score
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Oxford Hip score
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Radiological analysis
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
Time frame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery
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