NCT03865524Completed
Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 159 (actual)
- First submitted
- 5 Mar 2019
- Start date
- 7 Feb 2019
- Primary completion date
- 6 Nov 2024
- Lead sponsor
- Pedro-José Torrijos-Garrido
- Diseases
- Obesity
- NCT number
- NCT03865524
What you commit to
- Study type: Interventional
- Participants enrolled: 159
- From 7 Feb 2019 to the primary completion date, 6 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- 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
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Santa Cristina Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.