Efficacy and Safety of NAVIO
Comparison of Clinical Outcome and Alignment of NAVIO Total Knee Arthroplasty and Conventional Total Knee Arthroplasty A Prospective, Randomized, Controlled, Single Blind Study
Sint-Trudo Hospital
180 participants
Feb 1, 2021
INTERVENTIONAL
Conditions
Summary
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 Criteria5
- 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 Criteria6
- 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
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Interventions
total knee arthroplasty
The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04230616