Actively Recruiting
Efficacy and Safety of NAVIO
Led by Sint-Trudo Hospital · Updated on 2021-03-18
180
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy and Safety of NAVIO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Painful and disabled knee joint caused by osteoarthritis involving one or more compartments confirmed by X-ray
- High need for pain relief and improved function
- 18 years or older
- Able and willing to follow study instructions
- Provided informed consent
You will not qualify if you...
- Active infection in the knee
- Any general infection
- Failure of a previous joint replacement
- Post-operative or post-traumatic misalignment of the knee or leg
- Pregnancy
- Unable or unwilling to have CT scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orthopaedic Association Sint-Trudo Hospital
Sint-Truiden, Limburg, Belgium, 3800
Actively Recruiting
Research Team
P
Peter Bollars, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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