PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial

Orthosensor, Inc.1 site in 1 country20 target enrollmentApril 1, 2018

ConditionsOsteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Orthosensor, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Rehabilitation Potential
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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 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)
Patient perception of a balanced knee

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

October 12, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Orthosensor, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be a candidate for a primary PCL retaining total knee arthroplasty
•Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
•Subject is between the age of 45 - 80 years
•Subject is likely to be available for all study visits
•Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

•Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
•Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees