Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

OrthoSensor

Status

Terminated

Conditions

Osteoarthritis

Treatments

Device: Sensor-assisted TKR (Verasense)

Procedure: Control - Without the use of Verasense

Study type

Interventional

Funder types

Industry

Identifiers

NCT02290119

101

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

45 to 80 years old

Volunteers

Accepts Healthy Volunteers

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