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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement

• Registration Number: NCT04912973
• Lead Sponsor: Philip Winnock de Grave, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-01-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adjusted Mechanical Alignment	Robotically Assisted Total Knee Arthroplasty - Knee Replacement	-
inverse Kinematic Alignment	Robotically Assisted Total Knee Arthroplasty - Knee Replacement	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AZDelta; 🇧🇪 Roeselare, Belgium