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Patient-Specific Versus Conventional Instrumentation in TKA (Visio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02002624
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):
Moussa Hamadouche, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: PSI Device: Conventional instrumentation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Conventional
Conventional instrumentation
Device: Conventional instrumentation
Experimental: PSI
Patient specific instrumentation
Device: PSI
Other Name: Patient specific instrumentation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Blood loss [ Time Frame: 5 days ]
    According to Mercuriali et al.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02002624

Sponsors and Collaborators
Cochin Hospital
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Study Director: Stephane Boisgard, MD, PhD University Hospital, Clermont-Ferrand
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Responsible Party: Moussa Hamadouche, MD, PhD, Cochin Hospital Identifier: NCT02002624    
Other Study ID Numbers: CCP SC 2837
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases