Osteo Arthritis Knee
Conditions
Keywords
Total Knee Arthroplasty, Robot
Brief summary
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.
Interventions
PROCEDURETotal Knee Prosthesis - type Bicruciate retaining
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).
A total knee arthroplasty will be performed with robot-assistance (NAVIO).
PROCEDURETotal Knee Prosthesis - type Posterior Stabilized
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).
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome measures | Preoperative | 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. |
| Change in patient reported outcome measures | Postoperatively at 6 weeks, 6 months, 1 year and 2 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alignment | Preoperative and postoperatively at 6 weeks and 6 months. | 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. |
| Knee laxity | Preoperative and postoperatively at 1 year. | 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. |
| Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend. | Postoperatively at 1 year. | 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. |
Countries
Belgium
Outcome results
None listed