Osteoarthritis Clinical Trial
Official title:
A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon
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.
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