Robotic Assisted vs Custom Made Total Knee Arthroplasty (Knieathlon)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Custom made Total Knee Arthroplasty; Device: Functionally aligned robotically assisted total knee arthroplasty

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

Contacts and Locations

• Study Contact: Name: Antonio Klasan, MD, PhD, EMBA; Phone Number: +436765085920; Email: klasan.antonio@me.com

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8020
      • Recruiting
      • AUVA UKH Steiermark Standort Graz
      • Contact: Antonio Klasan, MD, PhD, EMBA
    • Kalwang, Styria, Austria, 8775
      • Recruiting
      • AUVA UKH Steiermark Standort Kalwang
      • Contact: Antonio Klasan, MD, PhD, EMBA

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• - 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

Exclusion Criteria:

• - The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
• Patient has had a previous osteotomy around the knee
• The patient is morbidly obese (BMI > 41)
• The patient has a deformity which will require the use of stems, wedges or augments
• The patient has a varus deformity ≥ 15°
• The patient has a valgus deformity >3°
• The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
• The patient is unable to speak German
• The patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome using the Forgotten Joint Score	Scale 0-100, higher score means better outcome	6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes using the Kujala anterior knee pain Score	Scale 0-100, higher score means better outcome	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Patient satisfaction	Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Visual analog pain (VAS) scale	Scale 0-10, higher score means better outcome	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Surgical and total theatre time		Perioperative phase
Opioid use	Total dosage of opioids, registered in Austria for pain management after knee replacement, administered to the patient during in-hospital stay: Hydromorphon, Tramadol, Oxycodone/Naloxon as well as number of ampules of Piritramid	Intraoperative stay
Number of physiotherapy sessions		Intraoperative stay
Range of motion measurements (in degrees)	Measurement using a manual goniometer.	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic data including radiolucent lines	Incidence of radiolucent lines >1 mm, with zones defined according to the New Knee Society Classification	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Revision rate		Minimum 2 years

Collaborators and Investigators

• Sponsor: Austrian Workers Compensation Board Styria

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AUVA_Knieathlon_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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