Robotic Assisted TKA

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06062615
• Other study ID #: MAUS 22D.103
• Status: Completed
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• Total knee replacement using Omnibot Knee System
total knee replacement with robotic assistance
• 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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early functional outcomes #1	This will be measured by the timed-up-and-go test.	6 months
Primary	Early functional outcomes #2	This will be measured by the stair climbing test.	6 months