Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted TKA | Experimental | Patients undergoing TKA with the assistance of robot technology. |
|
| Conventional TKA | Active Comparator | Patients undergoing TKA with manual instrumentarium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Total Knee Arthroplasty | Procedure | 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). |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Victor, MD, PhD | UZ Ghent | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40258174 | Derived | Vermue H, Arnout N, Tampere T, Stroobant L, Dereu A, Victor J. Standardized Intraoperative Robotic Laxity Assessment in TKA Leads to No Clinically Important Improvements at 2 Years Postoperatively: A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Oct 1;483(10):1866-1874. doi: 10.1097/CORR.0000000000003505. Epub 2025 Apr 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
Not provided
Not provided
Masked investigators will be responsible for the data processing and analysis. Reporting will be done together with non-masked authors.
| Robot-Assisted Total Knee Arthroplasty | Procedure | 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. |
|
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. |
| D012216 |
| Rheumatic Diseases |