Efficacy and Safety of NAVIO

Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

Inclusion Criteria:

• Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
• High need to obtain pain relief and improve function
• Above 18 years old
• Able and willing to follow instructions
• Informed consent

Exclusion Criteria:

• Active infection in knee
• General infection
• Failure of previous joint replacement
• Post-operative or post traumatic malalignment of the knee/leg
• Pregnancy
• Not able or willing to undergo CT-scan