Back to resultsEvaluation of PRO After TKA Under Spinal Anesthesia
Primary Purpose
Knee Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Surgery
Verasense Knee System device
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring Total Knee Replacement Arthroplasty
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Spinal Surgery
Sensor Guided Spinal Surgery
Arm Description
Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03053453
Brief Title
Evaluation of PRO After TKA Under Spinal Anesthesia
Official Title
Evaluation of the Patient Reported Outcomes After Sensor-guided Total Knee Arthroplasty Under Spinal Anesthesia With Limited Motor-block.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2016 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Total Knee Replacement Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Spinal Surgery
Arm Type
Active Comparator
Arm Description
Patients will be given spinal anesthesia with 2.6 mL of 0.5% isobaric bupivacaine.
Arm Title
Sensor Guided Spinal Surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Surgery
Intervention Description
TKA under standard of care spinal surgery.
Intervention Type
Device
Intervention Name(s)
Verasense Knee System device
Other Intervention Name(s)
OrthoSensor
Intervention Description
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 Measure Information:
Title
Knee Society Score (KSS)
Description
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.
Time Frame
Month 12 Post-Surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
Month 12 Post-Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Hertling, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of PRO After TKA Under Spinal Anesthesia
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