Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing

Study Overview
=================
Brief Summary
-----------------
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.

Official Title
-----------------
Evaluation of Robot-assisted Total Knee Arthroplasty With Automatic Balancing

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

Intervention / Treatment
-----------------
* Procedure: Conventional Total Knee Arthroplasty
* Procedure: Robot-Assisted Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage osteoarthritis of the knee joint with failed conservative treatment Exclusion Criteria: Previous ligament trauma of the MCL/LCL Previous fracture of femur or tibia Fixed flexion contracture > 10° Flexion < 110° Coronal deformity > 15° Previous infection of the knee joint Ligament insufficiency Neurologic conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted TKA<br>Patients undergoing TKA with the assistance of robot technology. | Procedure: Robot-Assisted Total Knee Arthroplasty<br>* People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot.<br>|
| Active Comparator: Conventional TKA<br>Patients undergoing TKA with manual instrumentarium | Procedure: Conventional Total Knee Arthroplasty<br>* People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Laxity | Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph. | Preoperative and postoperatively at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measures | The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems | Preoperative | 
| Patient reported outcome measures | The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Preoperative | 
| Patient reported outcome measures | The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Preoperative | 
| Patient reported outcome measures | The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems. | Preoperative | 
| Change in patient reported outcome measures | The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 
| Change in patient reported outcome measures | The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 
| Change in patient reported outcome measures | The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 
| Change in patient reported outcome measures | The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 
| Change in patient reported outcome measures | The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems. | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 
| Alignment | Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph. | Preoperative and postoperatively at 6 weeks and 6 months. | 
| Knee laxity anteroposterior | Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an anteroposterior laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300 Newton of force. | Preoperative and postoperatively at 1 year. | 
| Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend. | Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images. | Postoperatively at 1 year. |