Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Study Overview
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Brief Summary
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Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Detailed Description
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Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.

Official Title
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Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: KneeAlign 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only) Subjects willing to return for follow-up evaluations Exclusion Criteria: Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis) Severe OA deformation (FTA: >185 degrees or <175 degrees) Active Infection (or within 6 weeks after infection) Sepsis Osteomyelitis Any type of implant is inserted in the affected side of lower extremity Hip disease on the affected side Uncooperative patient or patient with neurologic disorders who are incapable of following directions diagnosed Osteoporosis or Osteomalacia Metabolic disorders which may impair bone formation Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy or neuromuscular disease.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vanguard with KneeAlign 2<br>Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2. | Device: KneeAlign 2<br>* 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.<br>* Other names: KneeAlign2;|
| No Intervention: Vanguard without KneeAlign 2<br>Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups. | Postoperative 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees) | Postoperative 6 months | 
| Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees) | Postoperative 6 months | 
| Number of Participants With Adverse Events and/or Adverse Device Effects | Number of participants, who experience adverse events and/or adverse device effects | Intra-operative and Post-operative 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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navigation system, palm-sized, total knee arthroplasty