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

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

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

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