NCT06284824

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Southeast Orthopedic Specialists · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Knee Arthritis
• Knee Disease

Interventions

Type	Name	Description
DEVICE	Stryker Triathlon with MAKO Robotic-Arm	Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
DEVICE	DePuy Attune with VELYS Robotic-Assistance	Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-02-29
• Last updated: 2024-04-17

Regulatory

• FDA-regulated device study