Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.
50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.
Accuracy of implant positioning and reconstruction of the mechanical leg axis are major
requirements for achieving good long-term results in total knee arthroplasty (TKA). A
minimally invasive approach might compromise the accuracy due to lacking intraoperative
oversight. The purpose of this study is to compare a minimally invasive TKA approach that
was performed under control of a navigation system with a standard navigated approach, with
respect to patient pain and range of motion.
All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation
system is used to control the alignment. Pain intensity using the Visual Analogue Scale
(VAS) and concomitant pain medication intake are documented daily during the first 20 days
after operation. As long as the patient is hospitalized the Range of Motion will also be
documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored
pre- and postoperatively.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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