Efficacy and Safety of NAVIO

Recruiting now · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT04230616

Run by

Sint-Trudo Hospital

People needed

180

Starts

2021-02-01

Expected to finish

2030-02-01

Last updated by the study team

2021-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orthopaedic Association Sint-Trudo Hospital — Sint-Truiden, Limburg, Belgium (enrolling)

Full record on ClinicalTrials.gov

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