Efficacy and Safety of NAVIO
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.