Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Hospital Universitario Santa Cristina
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Contact Information
Primary
Pedro José Torrijos Garrido, MD, PhD
pedrojose.torrijos@salud.madrid.org
+34 91 191 74 85
Backup
Concepción Payares Herrera, MD
cpayares@idiphim.org
+34 91 191 70 70
Time Frame
Start Date: 2019-02-07
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 158
Treatments
Experimental: Experimental
Total knee arthroplasty implanted with GPS navigation system.
Active_comparator: Control
Total knee arthroplasty implanted with standard guides.
Related Therapeutic Areas
Sponsors
Leads: Pedro-José Torrijos-Garrido