At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randmised Controlled Trial Comparing Electromagnetically Navigated Versus Conventional Mechanically Aligned Total Knee Arthroplasty
In Brief
A clinical study evaluating Electromagnetically navigated total knee arthroplasty and Conventional total knee arthroplasty for Arthroplasty, Replacement, Knee and Surgery, Computer-Assisted. Completed, enrolled 200 participants.
Detailed Summary
The aim of this single blinded randomised control trial study was to assess the accuracy of implantation of components and the clinical outcome and complications with the iNAV electromagnetic navigation system compared with conventional techniques. Secondary outcome measures include Patient reported outcome measures (PROMS) and rates of revision surgery up to 10 years post operatively.
Study Details
Timeline
Interventions
The navigated group had surgery using the iNav portable EM navigation system (Zimmer GmbH, Winterthur, Switzerland and Medtronic, Minneapolis, MN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing
The conventional group received surgery using conventional instrumentation and jigs from the implant manufacturer (Zimmer Inc, Warsaw, IN, USA) and the definitive implant used was NexGen LPS implant (Zimmer Inc, Warsaw, IN, USA), a fixed-bearing bicruciate-sacrificing total condylar implant using traditional instrumentation with no patellar resurfacing