Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
NCT ID: NCT03865524
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
158 participants
INTERVENTIONAL
2019-02-07
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
Total knee arthroplasty implanted with GPS navigation system.
Total knee arthroplasty implanted with GPS navigation system
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
Control
Total knee arthroplasty implanted with standard guides.
Total knee arthroplasty implanted with standard guides.
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total knee arthroplasty implanted with GPS navigation system
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
Total knee arthroplasty implanted with standard guides.
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pedro-José Torrijos-Garrido
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pedro-José Torrijos-Garrido
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pedro José Torrijos Garrido, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Santa Cristina
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NAOBE
Identifier Type: -
Identifier Source: org_study_id