NCT03865524

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Pedro-José Torrijos-Garrido · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomized, open and prospective clinical trial. 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

• Osteoarthritis, Knee
• Obesity
• Arthropathy of Knee

Interventions

Type	Name	Description
DEVICE	Total knee arthroplasty implanted with GPS navigation system	Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
DEVICE	Total knee arthroplasty implanted with standard guides.	Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides

Timeline

• Start date: 2019-02-07
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2019-03-07
• Last updated: 2023-11-28

Locations

2 sites across 1 country: Spain