Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment

Osteoarthritis, Knee Clinical Trial

— RATKA-CBO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04912973
• Other study ID #: B3222020000151
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: AZ Delta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Robotically Assisted Total Knee Arthroplasty - Knee Replacement
Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy

Locations

Country	Name	City	State
Belgium	AZDelta	Roeselare

Sponsors (2)

Lead Sponsor	Collaborator
Philip Winnock de Grave, MD	AZ Delta

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Analysis - walking speed - faster is better	Spatio Temporal Parameters are captured with infra-red camera during gait: velocity	2 year
Primary	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	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