Patient-Specific Versus Conventional Instrumentation in TKA (Visio)
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|ClinicalTrials.gov Identifier: NCT02002624|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: PSI Device: Conventional instrumentation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: Conventional
Device: Conventional instrumentation
Patient specific instrumentation
Other Name: Patient specific instrumentation
- Mechanical axis [ Time Frame: 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.
- Components position [ Time Frame: 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.
- Blood loss [ Time Frame: 5 days ]According to Mercuriali et al.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002624
|Study Director:||Stephane Boisgard, MD, PhD||University Hospital, Clermont-Ferrand|