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

Not Applicable

Terminated

• Conditions: Knee Injuries
• Interventions: Procedure: Spinal Surgery; Device: Verasense Knee System device

• Registration Number: NCT03053453
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-06
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-15
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Disposition First Submitted: 2023-07-12
• Disposition First Posted: 2023-07-28
• Results First Submitted: 2023-08-14
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Results First Posted: 2023-11-14
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Spinal Surgery	Spinal Surgery	Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.
Sensor Guided Spinal Surgery	Verasense Knee System device	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.

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Month 12 Post-Surgery	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.
Knee Society Score (KSS)	Month 12 Post-Surgery	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States