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

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053453
• Other study ID #: 16-00129
• Status: Terminated
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: July 13, 2022

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Procedure:
• Spinal Surgery
TKA under standard of care spinal surgery.

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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