The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery. The hypotheses are that the use of IOS technology will be associated with: 1. Better soft tissue balance during TKR than by manual balancing alone. 2. Higher patient reported clinical outcome measures (PROMs) following surgery.
Participation in this study will involve a knee replacement performed with IOS. Patients will be randomized into one of two groups:The study group will have soft tissue balance performed with the use of IOS. Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values. Intra-operative compartment loads will be measured in 10, 45, and 90 degrees of flexion. Additionally, long leg limb alignment, passive range of motion, use of opioids, daily activity, and PROMS will be evaluated post-operatively to determine which group has better outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.
Hospital for Special Surgery
New York, New York, United States
Knee Society Score
The primary outcome will be the difference in Knee Society Score (KSS) between baseline and 4 months post-operatively. The Knee Society Score is out of 100 points, with a higher score meaning a patient had a better outcome.
Time frame: 4 months
Intra-operative Compartment Loads
Intra-operative compartment loads (medial and lateral component loads) will be measured between the groups at 10, 45, and 90 degrees of flexion during trial reduction and after cementation, using IOS technology.
Time frame: Intra-operative
Long Leg Limb Alignment
Long leg limb alignment will be measured on post-operative standard of care (SOC) radiographs at patients' 6 week follow-ups.
Time frame: 6 weeks
Passive Range of Motion
Passive range of motion will be measured pre-operatively, 6 weeks post-operatively, and 4 months post-operatively at all scheduled SOC appointments.
Time frame: 4 months
Opioid Use
Use of opioids will be tracked using the Internet System for Tracking Over Prescribing (I-STOP) database and a daily pain diary maintained by patient for first 6 weeks post-operatively. The I-STOP database can be accessed by the prescribing physician to track how many opioid refills a patient has procured.
Time frame: 6 weeks
Function and Activity
Function and activity will be monitored using Fitness Trackers. The device will be given to each patient in hospital and is to be worn for 6 weeks post-operatively. It will monitor a patient's daily and weekly steps while the patient is wearing it.
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Time frame: 6 weeks
Pain Level
Daily pain levels will also be measured using the fitness tracker. The tracker will ask the patient to rate their pain on a scale from 0-10, with 0 meaning they have no pain, and 10 being the worst pain imaginable.
Time frame: 6 weeks