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Taking people in BelgiumNo phase

Efficacy and Safety of NAVIO

Key facts

Where
Sint-Truiden, BelgiumSee the site

Where in Belgium

  • Orthopaedic Association Sint-Trudo HospitalSint-Truiden, BelgiumContact: Peter Bollars, Dr.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Sint-Trudo Hospital
Trial code
NCT04230616
Record updated
18 March 2021
Original description
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.Read full original descriptionShow less

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

ClinicalTrials.gov NCT04230616