Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment (RATKA-CBO)

Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing

Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Roeselare, Belgium, 8800
    • AZDelta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures
2. Received a primary total knee replacement (incl. patella) robotically-assisted
3. Male or female
4. Age between 50 and 80
5. Able to walk independently

Exclusion Criteria:

1. Revision surgery
2. Patient with a history of neurological, psychiatric or neurodegenerative disease
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
4. Other musculoskeletal lesions that may affect the gait pattern

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: inverse Kinematic Alignment	Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement; Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy; Other Names: Triathlon Total Knee System of Stryker with Mako Robotic Platform; Triathlon Total Knee Replacement of Stryker
Active Comparator: adjusted Mechanical Alignment	Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement; Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy; Other Names: Triathlon Total Knee System of Stryker with Mako Robotic Platform; Triathlon Total Knee Replacement of Stryker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Analysis - walking speed - faster is better	Spatio Temporal Parameters are captured with infra-red camera during gait: velocity	2 year
Performance Testing - step-up step-down speed - faster is better	Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48	Questionnaire - Oxford Knee Score	baseline - 1 year - 2 year

Collaborators and Investigators

• Sponsor: Philip Winnock de Grave, MD
• Collaborators: AZ Delta

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; mechanical alignment; gait analysis; robotic surgery; alignment; performance testing; inverse kinematic alignment
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: B3222020000151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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