Using navigation technology to improve knee surgery outcomes in obese patients

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

This study is testing if using GPS navigation during knee surgery can help obese patients with knee osteoarthritis recover better and feel less pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Puerta de Hierro University Hospital (other)
• Locations: 2 sites (Majadahonda, Madrid and 1 other locations)
• Trial ID: NCT03865524 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a GPS navigation system in achieving proper alignment during total knee arthroplasty in obese patients with knee osteoarthritis. Participants will be randomly assigned to either a control group receiving standard surgical guides or an experimental group using the navigation system. The study will follow patients for up to 12 months post-surgery, collecting data on physical and radiological outcomes, pain levels, and overall functionality. The goal is to determine if navigation technology can enhance surgical precision and improve recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates are obese adults over 18 years old with symptomatic knee osteoarthritis requiring total knee arthroplasty.

Not a fit: Patients who are pregnant, unable to provide informed consent, or have had recent knee surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better surgical outcomes and improved quality of life for obese patients undergoing knee replacement.

How similar studies have performed: Previous studies have shown promising results with navigation systems in orthopedic surgeries, suggesting potential for success in this approach.

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.

Where this trial is running

Majadahonda, Madrid and 1 other locations

• Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Madrid, Spain (RECRUITING)
• Hospital Universitario Santa Cristina — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Pedro José Torrijos Garrido, MD, PhD — Hospital Universitario Puerta de Hierro
• Study coordinator: Pedro José Torrijos Garrido, MD, PhD

Conditions: Osteoarthritis, Knee, Obesity, Arthropathy of Knee, Knee replacement, Arthroplasty