Osteoarthritis Clinical Trial
Official title:
A Double-blinded Randomised Controlled Trial Comparing the Performance of the Sigma® CR150 and Sigma® CR Knee Systems, When Used in Fixed Bearing Primary Cruciate Retaining Total Knee Arthroplasty for the Treatment of Osteoarthritis
This study will compare two very similar designs of knee replacement device. One device
(Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified
to enhance/accommodate higher flexion. The original device has been in widespread clinical
use with excellent results since 1996 and this study will determine whether the design
modifications of the newer device add further value. The newer device has been in clinical
use with good short-term(unpublished) outcomes since becoming commercially available in
January 2009.
Achieving higher knee flexion may be required for cultural reasons or by the increasingly
younger, more active patient population undergoing knee replacement today. In addition to
promoting flexion, it is also possible that this design change may help the knee replacement
to last longer than traditional implants in patients who achieve higher flexion. Therefore,
the study will compare the two devices in terms of survivorship, flexion and other measures
of the success of a total knee replacement (range of motion, knee-related quality of life,
activity and generic quality of life) over the short-term.
A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and
aged 50-75 years will be included at UK/international hospitals.
Study duration is 2 years and patients will complete standard knee outcome scores plus
radiological evaluation.
Subjects would receive one of the study devices regardless of their involvement in the study,
and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and
follow-up care will be as per the care they would receive outside of the study.
n/a
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