Osteoarthritis, Ultra-Congruent(UC) Insert Clinical Trial
Official title:
Comparison of Ultra-Congruent(UC) and Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty
Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)
total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee
arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty
has been postulated to provide reproducible femoral rollback and increased flexion. However,
posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to
several post-cam related problems, including post-cam dislocation, wear and breakage of
post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone
resection and poses a risk for intercondylar fracture of the distal femur during box
preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent
(UC) total knee arthroplasty was introduced.
This study aims to compare the clinical results of Ultra-Congruent(UC) and
posterior-stabilized(PS) insert in bilateral total knee arthroplasty.
The objective of this work was to compare pain, stiffness, function and accuracy between
groups at minimum 2 year postoperatively. The investigators hypothesized that the
Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the
incidence of adverse events.
The study design is a double-blind randomized controlled trial. Fifty patients planed to
undergo simultaneously bilateral total knee arthroplasty are randomised to be used
Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. The
clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and
1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and
McMaster University Arthritis Index ) pain scale, Knee Society Score, Anterior and posterior
stress view on X-ray.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment