Vanguard TKA With KneeAlign 2 and Without KneeAlign 2
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT02695329
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
- Subjects willing to return for follow-up evaluations
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold Postoperative 6 months Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold Postoperative 6 months Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)
Number of Participants With Adverse Events and/or Adverse Device Effects Intra-operative and Post-operative 6 months Number of participants, who experience adverse events and/or adverse device effects
Trial Locations
- Locations (1)
Osaka City University
🇯🇵Osaka, Japan
Osaka City University🇯🇵Osaka, Japan