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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.
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 or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments: Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study. After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Santa Cristina
Madrid, Spain
Start Date
February 7, 2019
Primary Completion Date
June 30, 2024
Completion Date
June 30, 2024
Last Updated
November 28, 2023
158
ESTIMATED participants
Total knee arthroplasty implanted with GPS navigation system
DEVICE
Total knee arthroplasty implanted with standard guides.
DEVICE
Lead Sponsor
Pedro-José Torrijos-Garrido
NCT07472881
NCT01143454
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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