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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
Hospital Universitario Santa Cristina
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Deviation in a mechanical axis of knees
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º
Time frame: 12 months
Radiological axes (femoral)
Position angle of the femoral component: angle formed between the anatomical axis of the femur and the articular surface of the femoral component of the TKA (α).
Time frame: 12 months
Radiological axes (tibial)
Position angle of the tibial component: angle formed between the anatomical axis of the tibia and the proximal surface of the tibial component of the TKA (β).
Time frame: 12 months
Surgical procedure time
Surgical time
Time frame: Week 1
Admission (hospital) duration
Number of days of the hospital admission
Time frame: Week 1
Number of Surgical complications (Intraoperative)
Intraoperative complications
Time frame: Week 1
Number of Surgical complications (perioperative)
perioperative complications
Time frame: 1 to 6 weeks
Number of Surgical complications (post-operative)
postoperative complications
Time frame: 1-12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.