Robotic Assisted vs Custom Made Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

— Knieathlon  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280352
• Other study ID #: AUVA_Knieathlon_2024
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Austrian Workers Compensation Board Styria
• Contact: Antonio Klasan, MD, PhD, EMBA
• Phone: +436765085920
• Email: klasan.antonio[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)
• 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

Locations

Country	Name	City	State
Austria	AUVA UKH Steiermark Standort Graz	Graz	Styria
Austria	AUVA UKH Steiermark Standort Kalwang	Kalwang	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Workers Compensation Board Styria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Visual analog pain (VAS) scale	Scale 0-10, higher score means better outcome	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	Surgical and total theatre time		Perioperative phase
Secondary	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
Secondary	Number of physiotherapy sessions		Intraoperative stay
Secondary	Range of motion measurements (in degrees)	Measurement using a manual goniometer.	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary	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
Secondary	Revision rate		Minimum 2 years