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Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

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.

NCT06284824•Southeast Orthopedic Specialists

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Key Dates

Start Date

May 1, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2027

Last Updated

April 17, 2024

Enrollment

120

ESTIMATED participants

Conditions

Knee OsteoarthritisKnee ArthritisKnee Disease

Interventions

Stryker Triathlon with MAKO Robotic-Arm

DEVICE

DePuy Attune with VELYS Robotic-Assistance

DEVICE

Contacts

Alexis Velez, BS

CONTACT

13214439922 alexisavelez@gmail.com

John Redmond, MD

CONTACT

9043286711 john.redmond@live.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

Inclusion Criteria

Exclusion Criteria

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