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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent must be obtained prior to any screening procedures Received a primary total knee replacement (incl. patella) robotically-assisted Male or female Age between 50 and 80 Able to walk independently Exclusion Criteria: Revision surgery Patient with a history of neurological, psychiatric or neurodegenerative disease Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Other musculoskeletal lesions that may affect the gait pattern

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inverse Kinematic Alignment<br> | Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement<br>* Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy<br>* Other names: Triathlon Total Knee Replacement of Stryker;|
| Active Comparator: adjusted Mechanical Alignment<br> | Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement<br>* Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing