500
Participants
Start Date
April 30, 2015
Primary Completion Date
May 31, 2020
Study Completion Date
May 31, 2020
"TKA with Verasense"
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA pre-market submission (510K) clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
"TKA without Verasense"
TKA will be performed manually without the use of Verasense
NYU Hospital for Joint Diseases, New York
Virginia Commonwealth University, Richmond
Emory University, Atlanta
The Cleveland Clinic Foundation, Weston
The Cleveland Clinic Foundation, Cleveland
Illinois Bone & Joint Institute, Morton Grove
Lead Sponsor
Orthosensor, Inc.
INDUSTRY