NCT04251442

TKR With and Without the Use of Intra-operative Sensing

Randomized Controlled Trial of Patients Undergoing a Total Knee Arthroplasty With and Without the Use of Intraoperative Sensing Technology

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-31
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2020-02-05
• Last updated: 2022-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study