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

Pedro-José Torrijos-Garrido

Status: Enrolling

Conditions: Obesity; Arthropathy of Knee; Osteoarthritis, Knee

Treatments: Device: Total knee arthroplasty implanted with GPS navigation system; Device: Total knee arthroplasty implanted with standard guides.

Study type: Interventional

Funder types: Other

Identifiers

NCT03865524

NAOBE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Experimental

Experimental group

Description:

Total knee arthroplasty implanted with GPS navigation system.

Treatment:

Device: Total knee arthroplasty implanted with GPS navigation system

Control

Active Comparator group

Description:

Total knee arthroplasty implanted with standard guides.

Treatment:

Device: Total knee arthroplasty implanted with standard guides.