Patient-Specific Versus Conventional Instrumentation in TKA (Visio)

Cochin Hospital

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Conventional instrumentation; Device: PSI

Study type: Interventional

Identifiers

NCT02002624

CCP SC 2837

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Conventional

Active Comparator group

Description:

Conventional instrumentation

Treatment:

Device: Conventional instrumentation

PSI

Experimental group

Description:

Patient specific instrumentation

Treatment:

Device: PSI