Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients

Launched by PEDRO-JOSÉ TORRIJOS-GARRIDO · Mar 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how using special navigation technology can help achieve better alignment of the knee joint during total knee replacement surgery in obese patients. Proper alignment is important because it can lead to better outcomes and less pain after the surgery. The trial is specifically looking at patients with knee osteoarthritis who have a body mass index (BMI) of 30 or higher, meaning they are considered obese.

To participate, individuals must be at least 18 years old and provide written consent to join the study. They should have knee osteoarthritis and need a knee replacement based on their doctor’s recommendations. However, some people may not be eligible, such as pregnant women, those who have had recent knee surgeries, or individuals with certain medical conditions that could affect the results. If you qualify and decide to participate, you can expect to receive either the standard knee replacement or the one guided by navigation technology, and researchers will monitor your recovery closely to see how well the surgery works for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • 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.