Robotic Assisted TKA

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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Procedure: Conventional Total knee replacement; Procedure: Total knee replacement using Omnibot Knee System; Device: Omnibot Robotic Knee System

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
• Diagnosis of primary osteoarthritis

Exclusion Criteria:

• Revision surgery
• Bilateral knee surgery
• Age <18 or >80
• BMI >40
• Baseline lower extremity strength less than 5/5
• History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
• Functionally limiting spine disease
• Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
• Patients who cannot perform the baseline functional tests
• Allergy/contraindication to protocol medications
• Post-traumatic arthritis
• Inflammatory arthritis
• Pregnancy
• Prisoners
• Patients receiving care as a result of a worker's compensable injury
• General anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total knee replacement (TKR) without Omnibot system; The participant will undergo TKR utilizing conventional techniques.	Procedure: Conventional Total knee replacement; Conventional total knee replacement without robotic assistance
Active Comparator: Total knee replacement (TKR) with Omnibot; The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System	Procedure: Total knee replacement using Omnibot Knee System; total knee replacement with 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early functional outcomes #1	This will be measured by the timed-up-and-go test.	6 months
Early functional outcomes #2	This will be measured by the stair climbing test.	6 months

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Investigators: Principal Investigator: Matt Austin, MD, Rothman Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MAUS 22D.103

Drug and device information, study documents

• 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.: Yes