Evaluation of Patient Reported Outcomes (PRO) After Total Knee Arthroplasty (TKA) Under Spinal Anesthesia

Study Overview
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Brief Summary
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The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique. Each patient will be assessed for the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance.

Official Title
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Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.

Conditions
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Knee Injuries

Intervention / Treatment
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* Procedure: Spinal Surgery
* Device: Verasense Knee System device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be screened for eligibility based on whether they have chronic knee pain as a result of an arthritis-related condition. Patient with chronic knee pain who is indicated for total hip or knee replacement surgery Patient is at least 50 years of age Patient is willing to participate in pre- and postoperative surveys Exclusion Criteria: Failure to complete pre-operative surveys. Revision Total Knee Arthroplasty Prior ipsilateral knee surgery such as ligament reconstruction or osteotomy Contralateral Total Knee Arthroplasty Prior tibial plateau fracture Ligamentous Insufficiency History of fibromyalgia, chronic fatigue syndrome

Ages Eligible for Study
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Minimum Age: 50 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
Interventional Model Description: This is a randomized prospective study looking at the impact sensor guidance has on the outcome of patients and comparing to that of patients with a standard technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Spinal Surgery<br>Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine. | Procedure: Spinal Surgery<br>* TKA under standard of care spinal surgery.<br>|
| Experimental: Sensor Guided Spinal Surgery<br>The Verasense Knee System device (OrthoSensor inc., Dania Beach, Florida) is a sterile sensor system that replaces the tibial insert trials used during surgery. The sensor contains a microprocessor and integrated nanosensor system, which wirelessly transmits real-time data to a portable graphic display unit used for read-out of the data. The sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system. | Device: Verasense Knee System device<br>* Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.<br>* Other names: OrthoSensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) | The Knee Society Score (KSS) comprises two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | Month 12 Post-Surgery | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, function in daily living (ADLs), sports/recreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems. | Month 12 Post-Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement Arthroplasty