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Efficacy and Safety of NAVIO

Efficacy and Safety of NAVIO

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Osteoarthritis
    Knee

NCT04230616

Sint-Trudo Hospital

28 January 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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