Robotic Assisted TKA

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06062615

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement	Procedure: Total knee replacement using Omnibot Knee System Procedure: Conventional Total knee replacement Device: Omnibot Robotic Knee System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

early functional outcomes #1 [6 months]
This will be measured by the timed-up-and-go test.
Early functional outcomes #2 [6 months]
This will be measured by the stair climbing test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

Principal Investigator: Matt Austin, MD, Rothman Orthopaedic Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT06062615

Other Study ID Numbers:

MAUS 22D.103

First Posted:

Oct 2, 2023

Last Update Posted:

Oct 2, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Oct 2, 2023