The purpose of this study is to compare the performance and compare the wear characteristics of two polyethylene cup liners, Marathon™ and Enduron™, 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 polyethylene cup liners, Marathon™ or Enduron™ and will be evaluated at regular intervals using clinical and x-ray assessments.
The original protocol intended to perform clinical assessment using the Harris Hip Score, Merle D'Aubigne score and UCLA Activity Level Rating at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post-operative. Merle D'Aubigne score evaluation was removed per Amendment 2. However, protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery. Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
122
University Otago, Wellington Medical School of Medicine
Wellington, New Zealand
Evaluate the linear and volumetric wear at the three-year time point.
Time frame: 10yrs post surgery
Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively
Time frame: 10yrs post surgery
Radiographic analysis
Time frame: 10yrs post surgery
Oxford Hip Score
Time frame: 10yrs post surgery
SF-12 for Mental and Physical well-being
Time frame: 10yrs post surgery
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