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

Study Overview
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Brief Summary
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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 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

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Sensor-assisted TKR (Verasense)
* Procedure: Control - Without the use of Verasense


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 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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control - Without the use of Verasense<br>Total Knee Replacement without the use of intraoperative sensors | Procedure: Control - Without the use of Verasense<br>* Patients in this cohort will undergo manual total knee replacement without the use of Verasense<br>|
| Active Comparator: Sensor-assisted TKR (Verasense)<br>Total Knee Replacement with the use of intraoperative sensors | Device: Sensor-assisted TKR (Verasense)<br>* Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation Potential |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Pain and Functional Scoring (KSS) | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. | 6 month | 
| Forgotten Joint Score (FJS) | The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities. | 6 month | 
| 3D Gait Analysis velocity | 3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s. | 6 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes