Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis Clinical Trial
Official title:
A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty
Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.
It is of great importance for the function of uncemented total hip arthroplasty that the
anchorage of the prosthesis in the bone of the femur is sufficient. This is of great
importance in the prevention of stress shielding of the bone and to insure tranfer of forces
from the prosthesis to the femur.
The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical
stability.
In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used
and long term evaluated uncemented hip prosthesis) During the fist two years of follow up
DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient
fuction score and radiological evaluation measurements are done during 5 years of follow up.
Our primary objective is: comparison of the short term bone remodelling surrounding the
Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem
measured by bone densitometry, clinical and radiographic evaluation.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment