Patient-Specific Versus Conventional Instrumentation in TKA

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Conventional instrumentation; Device: PSI

• Registration Number: NCT02002624
• Lead Sponsor: Cochin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-12
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-05
• Last Update Submitted: 2013-12-05
• Study First Posted: 2013-12-06
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional instrumentation	Conventional instrumentation
PSI	PSI	Patient specific instrumentation

Primary Outcome Measures

Name	Time	Method
Mechanical axis	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Components position	3 months	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.