Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)

NATerminatedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

May 31, 2020

Study Completion Date

May 31, 2020

Conditions
Osteoarthritis
Interventions
DEVICE

"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.

PROCEDURE

"TKA without Verasense"

TKA will be performed manually without the use of Verasense

Trial Locations (6)

10003

NYU Hospital for Joint Diseases, New York

23284

Virginia Commonwealth University, Richmond

30329

Emory University, Atlanta

33331

The Cleveland Clinic Foundation, Weston

44195

The Cleveland Clinic Foundation, Cleveland

60053

Illinois Bone & Joint Institute, Morton Grove

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Orthosensor, Inc.

INDUSTRY

NCT02286739 - Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA) | Biotech Hunter | Biotech Hunter