Patient-Specific Versus Conventional Instrumentation in TKA

N/ACompletedNCT02002624

Cochin Hospital140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Osteoarthritis, Knee

Interventions

PSIDEVICE

Conventional instrumentationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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