NCT02286739

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Orthosensor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2014-11-10
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

6 sites across 1 country: United States