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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• \- The patient is a male or non-pregnant female between the ages of 40 and 90 years

• The patient requires a primary total knee replacement

• Patient is deemed appropriate for a cruciate retaining knee replacement

• The patient has a primary diagnosis of osteoarthritis (OA)

• The patient has intact collateral ligaments

• The patient is able to undergo CT scanning of the affected limb

• The patient has signed the study specific, ethics-approved, informed consent document

• The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations

Locations
Other Locations
Austria
AUVA UKH Steiermark Standort Graz
RECRUITING
Graz
AUVA UKH Steiermark Standort Kalwang
RECRUITING
Kalwang
Contact Information
Primary
Antonio Klasan, MD, PhD, EMBA
klasan.antonio@me.com
+436765085920
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-04
Participants
Target number of participants: 120
Treatments
Experimental: Custom made Total Knee Arthroplasty
Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Active_comparator: Functionally aligned robotically assisted total knee arthroplasty
Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker)
Sponsors
Leads: Austrian Workers Compensation Board Styria

This content was sourced from clinicaltrials.gov