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

NCT03053453 | Terminated Results FDA Device

• 1 other identifier: 16-00129
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries

Keywords

Total Knee Replacement Arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard of Care Spinal Surgery

ACTIVE COMPARATOR

Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.

Procedure: Spinal Surgery

Sensor Guided Spinal Surgery

EXPERIMENTAL

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

Interventions

Spinal Surgery PROCEDURE

TKA under standard of care spinal surgery.

Standard of Care Spinal Surgery

Verasense Knee System device 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.

Also known as: OrthoSensor

Sensor Guided Spinal Surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. Arthur Hertling
• Organization: NYU Langone Health

Arthur.Hertling@nyulangone.org

2125986085

Study Officials

• Arthur Hertling, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 15, 2017
• Study Start: December 6, 2016
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: November 14, 2023
• Results First Posted: November 14, 2023

Record last verified: 2023-10

Locations

US (1)