Back to resultsPatient-Specific Versus Conventional Instrumentation in TKA (Visio)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PSI
Conventional instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional
PSI
Arm Description
Conventional instrumentation
Patient specific instrumentation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02002624
Brief Title
Patient-Specific Versus Conventional Instrumentation in TKA
Acronym
Visio
Official Title
RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cochin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional instrumentation
Arm Title
PSI
Arm Type
Experimental
Arm Description
Patient specific instrumentation
Intervention Type
Device
Intervention Name(s)
PSI
Other Intervention Name(s)
Patient specific instrumentation
Intervention Type
Device
Intervention Name(s)
Conventional instrumentation
Primary Outcome Measure Information:
Title
Mechanical axis
Description
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 Outcome Measure Information:
Title
Components position
Description
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
Other Pre-specified Outcome Measures:
Title
Blood loss
Description
According to Mercuriali et al.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Boisgard, MD, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Patient-Specific Versus Conventional Instrumentation in TKA
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