Knee Joint Diseases
Conditions
Interventions
Persona TKA with iASSIST Knee as the Investigational group
Persona TKA with conventional instrumentation and without iASSIST Knee as the Control group
Sponsors
Zimmer Biomet G. K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Knee Osteoarthritis (varus deformity only) - Subjects willing to return for follow-up evaluations
Exclusion criteria
Exclusion criteria: - Severe OA deformation (FTA:>190 deg/ <175 deg) - Active Infection (or within 6 weeks after infection) - Sepsis - Osteomyelitis - Any type of implant is inserted in the affected side of lower extremity - Hip and lower limb diseases 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 |
|---|---|
| The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group. | — |
Countries
Japan
Contacts
Public ContactFumiya Ohmasa
Zimmer Biomet G. K. Clinical Affairs
Outcome results
None listed