TKR With and Without the Use of Intra-operative Sensing
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|ClinicalTrials.gov Identifier: NCT04251442|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 19, 2020
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:
- Better soft tissue balance during TKR than by manual balancing alone.
- Higher patient reported clinical outcome measures (PROMs) following surgery.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: OrthoSensor Verasense Technology||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of Patients Undergoing a Total Knee Arthroplasty With and Without the Use of Intraoperative Sensing Technology|
|Actual Study Start Date :||February 12, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Study Group
The study group will have soft tissue balance performed with the use of IOS.
Device: OrthoSensor Verasense Technology
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.
No Intervention: Control Group
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.
- Knee Society Score [ Time Frame: 4 months ]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.
- Intra-operative Compartment Loads [ Time Frame: Intra-operative ]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.
- Long Leg Limb Alignment [ Time Frame: 6 weeks ]Long leg limb alignment will be measured on post-operative standard of care (SOC) radiographs at patients' 6 week follow-ups.
- Passive Range of Motion [ Time Frame: 4 months ]Passive range of motion will be measured pre-operatively, 6 weeks post-operatively, and 4 months post-operatively at all scheduled SOC appointments.
- Opioid Use [ Time Frame: 6 weeks ]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.
- Function and Activity [ Time Frame: 6 weeks ]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.
- Pain Level [ Time Frame: 6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251442
|Contact: Kate Shanaghanfirstname.lastname@example.org|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Kate Shanaghan 212-774-2490 email@example.com|
|Principal Investigator:||Alejandro Gonzalez Della Valle, MD||Hospital for Special Surgery, New York|
|Study Director:||Kate Shanaghan||Hospital for Special Surgery, New York|