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The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Conventional instrumentation |
|
| PSI | Experimental | Patient specific instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSI | Device |
|
| |
| Conventional instrumentation |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical axis | Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Components position | Also, components position in the coronal plane was measured on both the tibial and femoral sides by the femoral (F) angle between the tangent line of the distal prosthetic condyles and the mechanical axis of the femur, and by the tibial (T) angle between the tangent line of the prosthetic tibial baseplate and the mechanical axis of the tibia. In addition in the sagittal plane, tibial slope (TS) was measured by the angle between the tangent of the tibial baseplate and the posterior cortex of the tibia on a lateral view of the knee made at three-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | According to Mercuriali et al. | 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane Boisgard, MD, PhD | University Hospital, Clermont-Ferrand | Study Director |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Device |
|
| 3 months |
| D012216 |
| Rheumatic Diseases |