NCT06062615

Robotic Assisted TKA

Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.

Conditions

• Total Knee Replacement

Interventions

Type	Name	Description
PROCEDURE	Total knee replacement using Omnibot Knee System	total knee replacement with robotic assistance
PROCEDURE	Conventional Total knee replacement	Conventional total knee replacement without robotic assistance
DEVICE	Omnibot Robotic Knee System	utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-10-02
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study