The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is stable and effective in treatment of patients with joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to allow the position of the Silent Hip within the bone to be accurately monitored.
The Primary Objective of this study was to evaluate the short-term stability of the Silent Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA). The study was also intended to provide the clinical data necessary to demonstrate conformance with the essential requirements of the Medical Device Directive. Secondary objectives were to determine the efficacy of the Silent™ Hip femoral prosthesis from a clinical and radiological prospective, to assess the safety of the device and to evaluate the impact of the procedure on the Subjects' Quality of Life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
A short cementless, femoral component for use in total hip arthroplasty
Sydney Adventist Hospital
Sydney, Australia
General Hospital Eilbek
Hamburg, Germany
The translational and rotational movements of the Silent™ hip in the 3 dimensions from the baseline position (determined from the 7 day post-operative RSA x-rays) to the 1 year follow-up visit.
Time frame: 1year post-surgery
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 1 year
Difference demonstrated between pre-op and 5 year Harris Hip Score
Time frame: 5 years post surgery
Difference demonstrated between pre-op and 5 year Oxford Hip Score
Time frame: 5years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 3 months post surgery
Difference demonstrated between pre-op and 10 year Harris Hip Score
Time frame: 10 years post surgery
Difference demonstrated between pre-op and 10 year Oxford Hip Score
Time frame: 10 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 6 months post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 1 year post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 18 months post surgery
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Incidence of radiological signs on the post-operative x-rays
Time frame: 2 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 5 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 10 years post surgery
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 2 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 5 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 10 years