NCT06280352

Robotic Assisted vs Custom Made Total Knee Arthroplasty

Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Austrian Workers Compensation Board Styria · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are: * Which implant/philosophy yields better clinical outcomes? * Which implant/philosophy yields better satisfaction? * Which system is more OR efficient? Participants will be followed for 2 years postoperatively.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Custom made Total Knee Arthroplasty	Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
DEVICE	Functionally aligned robotically assisted total knee arthroplasty	Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2024-02-28
• Last updated: 2025-01-28

Locations

2 sites across 1 country: Austria

Regulatory

• FDA-regulated device study