The purpose of this study is to determine if the Silent™ hip is effective 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 undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored
The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective 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 undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
A short cementless, femoral component for use in total hip arthroplasty
Royal Newcastle Hospital
Broadmeadow, Australia
Prince of Wales Private Hospital
Sydney, Australia
Sydney Adventist Hospital
Sydney, Australia
Hôpital Raymond Poincaré
Garches, France
Incidence of complications
Time frame: 6mths post-surgery
Harris Hip score change at 6mths post-surgery
Time frame: 6mths post-surgery
Harris Hip Score
Time frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Oxford Hip Score
Time frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
UCLA Activity Rating
Time frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Incidence of post operative radiological signs
Time frame: 7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Change in bone mineral density
Time frame: 7days, 3mths, 6mths, 1yr and 2yrs post-surgery
Kaplan-Meier Survivorship Calculations
Time frame: 3 months, 6 months, and Annually
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Orthopädishe Universitätsklinik
Frankfurt, Germany
Ospedali Riuniti di Jesi
Iesi, Italy
Llandough Hospital
Cardiff, United Kingdom