Knee Joint Diseases
Conditions
Interventions
Vanguard with KneeAlign 2 as investigational group.
Vanguard with conventional instrumentation and without KneeAlign 2 as control group.
Sponsors
Zimmer Biomet G. K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only) - Subjects willing to return for follow-up evaluations
Exclusion criteria
Exclusion criteria: - Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis) - Severe OA deformation (FTA:> 185 degrees / < 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects that have alignment within 2 degrees from neutral on tibia at postoperative 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery time, Tibial posterior slope alignment, Femoral varus/valgus angle, frequency to perform re-osteotomy for angle correction with KneeAlign2, and collection of adverse events/ adverse device effects | — |
Countries
Japan
Contacts
Public ContactTakahito Nakai
Zimmer Biomet G. K. Clinical Affairs
Outcome results
None listed