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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Disease
• Intervention / Treatment: Device: Stryker Triathlon with MAKO Robotic-Arm; Device: DePuy Attune with VELYS Robotic-Assistance

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis Velez, BS; Phone Number: 13214439922; Email: alexisavelez@gmail.com
• Study Contact Backup: Name: John Redmond, MD; Phone Number: 9043286711; Email: john.redmond@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAKO group; Patients in this arm will receive the Stryker Triathlon implant and the MAKO robotic arm will be used during surgery.	Device: Stryker Triathlon with MAKO Robotic-Arm; Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
Experimental: VELYS group; Patients in this arm will receive the DePuy Attune implant and the VELYS robotic arm will be used during surgery.	Device: DePuy Attune with VELYS Robotic-Assistance; Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KSS	Knee Society Score	baseline
KSS	Knee Society Score	6 week
KSS	Knee Society Score	12 week
KSS	Knee Society Score	1 year
KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	baseline
KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	6 week
KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	12 week
KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	1 year
FJS-12 Knee	Forgotten Joint Score	6 week
FJS-12 Knee	Forgotten Joint Score	12 week
FJS-12 Knee	Forgotten Joint Score	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative step time	Timing for use of robot during surgery	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone resected	Amount of bone resected	Intraoperative
Costs for surgery	Factors associated with insurance costs for surgery	Immediate post operative

Collaborators and Investigators

• Sponsor: Southeast Orthopedic Specialists
• Collaborators: DePuy Orthopaedics; Stryker Orthopaedics
• Investigators: Principal Investigator: John Redmond, MD, Southeast Orthopedic Specialists

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: arthroplasty; TKA; robotic assistance
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DPS-JMP-2022-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes