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Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03865524
Study type Interventional
Source Puerta de Hierro University Hospital
Contact Pedro José Torrijos Garrido, MD, PhD
Phone +34 91 191 74 85
Status Recruiting
Phase N/A
Start date February 7, 2019
Completion date December 31, 2021

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