Osteoarthritis, Knee
Conditions
Brief summary
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
Interventions
PROCEDUREConventional Total Knee Arthroplasty
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).
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.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masked investigators will be responsible for the data processing and analysis. Reporting will be done together with non-masked authors.
Intervention model description
Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| 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. |
| 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 anteroposterior | Preoperative and postoperatively at 1 year. | 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. |
| 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