NCT04057885

To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: LifeBridge Health · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty

Detailed description

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee

Conditions

• Degenerative Arthritis

Interventions

Type	Name	Description
DEVICE	Orthosensor™ VERASENSE™ Knee System	A group of patients will receive a total knee arthroplasty using the Orthosensor device

Timeline

• Start date: 2017-05-15
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2019-08-15
• Last updated: 2020-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study