To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Degenerative Arthritis

Intervention / Treatment
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* Device: Orthosensor™ VERASENSE™ Knee System


Participation Criteria
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Eligibility Criteria
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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 Minimum age: 45 Maximum age: 80 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 f ) flexion contracture of more than 20 degrees

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Arm<br>A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance | Device: Orthosensor™ VERASENSE™ Knee System<br>* A group of patients will receive a total knee arthroplasty using the Orthosensor device<br>|
| Active Comparator: Standard of Care<br>10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data. | Device: Orthosensor™ VERASENSE™ Knee System<br>* A group of patients will receive a total knee arthroplasty using the Orthosensor device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with improvement in gait. |  | 18 months | 
| Proportion of patients not requiring long term rehabilitation. |  | 18 months | 
| Proportion of patients with improved function as measured by standardized knee scores. |  | 18 months |