Randomized controlled study comparing iASSIST Knee system versus conventional instrumentation

UMIN ID: UMIN000027545

Registered date:30/05/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Knee Joint Diseases
• Date of first enrollment: 2017/06/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Persona TKA with iASSIST Knee as the Investigational group
Persona TKA with conventional instrumentation and without iASSIST Knee as the Control group

Outcome(s)

• Primary Outcome: The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.
• Secondary Outcome: Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Zimmer Biomet G. K.
• Source(s) of Monetary Support: Zimmer Biomet G. K.