Evaluation of Standard and Robot Assisted Total Knee Arthroplasty With a Bicrucatie Retaining Prosthesis

Study Overview
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Brief Summary
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The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.

Official Title
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Evaluation of Standard and Robot Assisted Total Knee Arthroplasty With a Bicrucatie Retaining Prosthesis

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Procedure: Total Knee Prosthesis - type Bicruciate retaining
* Procedure: Robot-assisted Total Knee Arthroplasty
* Procedure: Total Knee Prosthesis - type Posterior Stabilized


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage osteoarthritis of the knee joint with failed conservative treatment Exclusion Criteria: Previous ligament trauma 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
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Posterior Stabilized TKA without robot Arm 2: Posterior Stabilized TKA with robot Arm 3: Bicruciate retaining TKA without robot Arm 4: Bicruciate retaining TKA with robot
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Posterior Stabilized TKA without robot-assistance<br>A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance | Procedure: Total Knee Prosthesis - type Posterior Stabilized<br>* A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).<br>|
| Experimental: Posterior Stabilized with robot-assistance<br>A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance | Procedure: Robot-assisted Total Knee Arthroplasty<br>* A total knee arthroplasty will be performed with robot-assistance (NAVIO).<br>Procedure: Total Knee Prosthesis - type Posterior Stabilized<br>* A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).<br>|
| Experimental: Bicruciate retaining TKA without robot-assistance<br>A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance | Procedure: Total Knee Prosthesis - type Bicruciate retaining<br>* A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).<br>|
| Experimental: Bicruciate retaining TKA with robot-assistance<br>A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance | Procedure: Total Knee Prosthesis - type Bicruciate retaining<br>* A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).<br>Procedure: Robot-assisted Total Knee Arthroplasty<br>* A total knee arthroplasty will be performed with robot-assistance (NAVIO).<br>|

What is the study measuring?
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Primary 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 
| Knee laxity | Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an AP 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 300N 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Robot