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Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

Osteoarthritis Clinical Trial

Official title:
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty

Clinical Trial Summary

The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.

Clinical Trial Description

Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02286739
Study type Interventional
Source Orthosensor, Inc.
Contact Christopher R. Anderson, MS, MBA
Phone (954) 372-2641
Email canderson@orthosensor.com
Status Recruiting
Phase N/A
Start date April 2015
Completion date December 2018
View Details
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