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NCT Number: NCT06284824

Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

* Will the patient reported outcomes differ between the two groups? * Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
  • Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
  • Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
  • Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
  • Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.

Exclusion criteria

  • Patient has a Body Mass Index (BMI) > 40.
  • Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
  • Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
  • Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
  • Subject is a woman who is pregnant or lactating.
  • Patient has a contralateral amputation.
  • Patient's affected knee has a flexion contracture greater than 15 degrees.
  • Patient has history of post operative arthrofibrosis.
  • Patient's affected knee has a partial knee arthroplasty.
  • Patient has undergone contralateral TKA within the last three months.
  • Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
  • Patient who is bedridden per the discretion of the investigator.
  • Patient has a medical condition with less than 2 years of life expectancy.

Treatment and study plan

Stryker Triathlon with MAKO Robotic-Arm

Device

Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm

DePuy Attune with VELYS Robotic-Assistance

Device

Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Primary outcomes

  1. KSS

    Time frame: baseline

    Knee Society Score

  2. KSS

    Time frame: 6 week

    Knee Society Score

  3. KSS

    Time frame: 12 week

    Knee Society Score

  4. KSS

    Time frame: 1 year

    Knee Society Score

  5. KOOS JR

    Time frame: baseline

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  6. KOOS JR

    Time frame: 6 week

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  7. KOOS JR

    Time frame: 12 week

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  8. KOOS JR

    Time frame: 1 year

    Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  9. FJS-12 Knee

    Time frame: 6 week

    Forgotten Joint Score

  10. FJS-12 Knee

    Time frame: 12 week

    Forgotten Joint Score

  11. FJS-12 Knee

    Time frame: 1 year

    Forgotten Joint Score

Secondary outcomes

  1. Operative step time

    Time frame: Intraoperative

    Timing for use of robot during surgery

Other outcomes

  1. Bone resected

    Time frame: Intraoperative

    Amount of bone resected

  2. Costs for surgery

    Time frame: Immediate post operative

    Factors associated with insurance costs for surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Velez, BS

CONTACT

[email protected]

13214439922

John Redmond, MD

CONTACT

[email protected]

9043286711

Sponsors and collaborators

Lead sponsor

Southeast Orthopedic Specialists

Network

Collaborators

  • DePuy Orthopaedics
  • Stryker Orthopaedics

Registry information

Official study title

Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Apr 17, 2024

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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