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

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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Injuries
• Intervention / Treatment: Procedure: Spinal Surgery; Device: Verasense Knee System device

Detailed 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. The study is also designed to evaluate the difference between passive, soft tissue controlled, pressure balance and muscle activated pressure balance. Prior to the randomized study, there will be an observational pilot of 25 patients. These patients will not be randomized and will receive standard of care anesthesia. The reason for the 25 pilot patients is to perfect the sensor guidance so all subsequent study patients will have a streamlined, consistent measurement.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Spinal Surgery; Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.	Procedure: Spinal Surgery; TKA under standard of care spinal surgery.
Experimental: Sensor Guided Spinal Surgery; 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; 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.; Other Names: OrthoSensor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Arthur Hertling, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Replacement Arthroplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: 16-00129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No