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OpenTrials
Completed

NCT Number: NCT06062615

Robotic Assisted TKA

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.

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Key information

Conditions

Total Knee Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee replacement using Omnibot Knee System

Procedure

total knee replacement with robotic assistance

Conventional Total knee replacement

Procedure

Conventional total knee replacement without robotic assistance

Omnibot Robotic Knee System

Device

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

Primary outcomes

  1. early functional outcomes #1

    Time frame: 6 months

    This will be measured by the timed-up-and-go test.

  2. Early functional outcomes #2

    Time frame: 6 months

    This will be measured by the stair climbing test.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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