NCT06062615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

September 25, 2023

Last Update Submit

April 30, 2025

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Total knee replacement (TKR) without Omnibot system

ACTIVE COMPARATOR

The participant will undergo TKR utilizing conventional techniques.

Procedure: Conventional Total knee replacement

Total knee replacement (TKR) with Omnibot

ACTIVE COMPARATOR

The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System

Procedure: Total knee replacement using Omnibot Knee SystemDevice: Omnibot Robotic Knee System

Interventions

Total knee replacement using Omnibot Knee SystemPROCEDURE

total knee replacement with robotic assistance

Total knee replacement (TKR) with Omnibot
Conventional Total knee replacementPROCEDURE

Conventional total knee replacement without robotic assistance

Total knee replacement (TKR) without Omnibot system
Omnibot Robotic Knee SystemDEVICE

utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery

Total knee replacement (TKR) with Omnibot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of primary osteoarthritis

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Lizcano JD, Restrepo S, Tarabichi S, Gold PA, Saxena A, Austin MS. Does the Use of a Robotic Gap-tensioning System Improve Functional Outcomes After TKA? A Randomized Clinical Trial. Clin Orthop Relat Res. 2025 Oct 22. doi: 10.1097/CORR.0000000000003734. Online ahead of print.

    PMID: 41191410DERIVED

Study Officials

  • Matt Austin, MD

    Rothman Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 2, 2023

Study Start

July 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

US(1)