Robotic Assisted vs Custom Made Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: Functionally aligned robotically assisted total knee arthroplasty; Device: Custom made Total Knee Arthroplasty

• Registration Number: NCT06280352
• Lead Sponsor: Austrian Workers Compensation Board Styria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functionally aligned robotically assisted total knee arthroplasty	Functionally aligned robotically assisted total knee arthroplasty	Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker)
Custom made Total Knee Arthroplasty	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of physiotherapy sessions	Intraoperative stay
Revision rate	Minimum 2 years
Clinical outcomes using the Kujala anterior knee pain Score	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months	Scale 0-100, higher score means better outcome
Patient satisfaction	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months	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
Visual analog pain (VAS) scale	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months	Scale 0-10, higher score means better outcome
Range of motion measurements (in degrees)	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months	Measurement using a manual goniometer.
Radiographic data including radiolucent lines	preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months	Incidence of radiolucent lines \>1 mm, with zones defined according to the New Knee Society Classification
Surgical and total theatre time	Perioperative phase
Opioid use	Intraoperative stay	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

Trial Locations

Locations (2)

AUVA UKH Steiermark Standort Graz; 🇦🇹 Graz, Styria, Austria

AUVA UKH Steiermark Standort Kalwang; 🇦🇹 Kalwang, Styria, Austria