Status:
UNKNOWN
Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
Lead Sponsor:
Pedro-José Torrijos-Garrido
Conditions:
Osteoarthritis, Knee
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
Detailed Description
Randomized, open and prospective clinical trial. Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal ...
Eligibility Criteria
Inclusion
- Men and women over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Exclusion
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03865524
Start Date
February 7 2019
End Date
June 30 2024
Last Update
November 28 2023
Active Locations (2)
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1
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
2
Hospital Universitario Santa Cristina
Madrid, Spain, 28009