Patient-Specific Versus Conventional Instrumentation in TKA

Study Overview
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Brief Summary
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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.

Official Title
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RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: PSI
* Device: Conventional instrumentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty aged between 18 and 85 years able to understand information affiliated to social security. Exclusion Criteria: active or suspected sepsis tumor around the knee previous partial or total knee replacement presence of hardware that could artifact MRI contraindication to MRI extra-articular deformation requiring osteotomy around the knee in conjunction with TKA social situation that could impair follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Conventional instrumentation | Device: Conventional instrumentation<br> <br> |
| Experimental: PSI<br>Patient specific instrumentation | Device: PSI<br> <br> * Other names: Patient specific instrumentation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 3 months |