Efficacy and Safety of NAVIO
Recruiting · NCT04230616 · Interventional (participants receive a specific treatment) · Lead sponsor: Sint-Trudo Hospital
View the official record on ClinicalTrials.gov →Interventions studied
CT scantotal knee arthroplasty
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Orthopaedic Association Sint-Trudo Hospital - Sint-Truiden, Limburg, Belgium