Medial Gonarthrosis
Conditions
Brief summary
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
Detailed description
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs. The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies. MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures. An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Age between 50 and 80 years * Indication for medial UKP * Intact anterior cruciate ligament * Good bone quality based on imaging * ASA score ≤ 3
Exclusion criteria
* Inflammatory joint diseases * Collateral ligament instability * Simultaneous bilateral procedure * BMI \> 35 * History of fracture or osteotomy in the knee joint * Neuromuscular diseases * Oncological indications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OKS | Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively. | Oxford Knee Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AMI | Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative. | Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804 for grading |
| Surgery time | Peroperatively | Operative time |
| Complications | Within 2 years postoperatively | Postoperative complications |
| Revision or reoperation | Within 2 years postoperatively | Revision or reoperation |
| c-FCA | 6 weeks and 4 months postoperatively | Coronal Femoral Component Alignment - Varus/valgus alignment for the femoral component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° degrees is considered neutral. |
| EQ-5D-5L | Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively. | The 5-level EQ-5D version. |
| NRS | Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.] | Numeric Rating Scale |
| KOOS-PS | Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively. | Knee Injury and Osteoarthritis Outcome Score-Physical function Short form |
| c-TCA | 6 weeks and 4 months postoperatively | Coronal Tibial Component Alignment - Varus/valgus alignment for the tibial component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° is considered neutral. |
| s-FCA | 6 weeks and 4 months postoperatively | Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior tibial cortex. A posteroinferior slope of 7° is considered neutral. |
| RLL | 6 weeks and 4 months postoperatively | Radiolucencies - Radiolucencies after UKR are divided into two types: physiological and pathological. The former are \< 2 mm thick, well defined, and accompanied by a parallel radiodense line, whereas the latter are \> 2 mm thick, ill defined, and lacking accompanying radiodense lines. The pattern observed should be recorded as well as their location, which is divided into six zones on the AP view of the tibial component and six zones on the lateral view of the femoral component. Evaluation based on the zones of the Knee Society. |
Countries
Belgium