Vanguard TKA With KneeAlign 2 and Without KneeAlign 2
|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.|
|ClinicalTrials.gov Identifier: NCT02695329|
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: KneeAlign 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional|
|Actual Study Start Date :||May 24, 2016|
|Actual Primary Completion Date :||October 3, 2018|
|Actual Study Completion Date :||October 26, 2018|
Active Comparator: Vanguard with KneeAlign 2
Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
Device: KneeAlign 2
Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Other Name: KneeAlign2
No Intervention: Vanguard without KneeAlign 2
Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.
- Proportion of subjects that have alignment within 2 degrees from neutral on tibia [ Time Frame: Postoperative 6 months ]Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.
- Tibial posterior slope alignment [ Time Frame: Postoperative 6 months ]Deviation of tibial posterior slope angle from preoperative planned angle
- Femoral varus/valgus angle [ Time Frame: Postoperative 6 months ]Deviation of femoral valus/valgus angle from preoperative planned angle
- Collection of adverse events and adverse device effects [ Time Frame: Intra-operative and Post-operative 6 months ]Collection of adverse events and adverse device effects observed
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695329
|Osaka City University|
|Osaka, Japan, 558-0022|
|Principal Investigator:||Yukihide Minoda||Osaka City University|