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

Not Applicable

Recruiting

• Conditions: Arthropathy of Knee; Osteoarthritis, Knee; Obesity
• Interventions: Device: Total knee arthroplasty implanted with GPS navigation system; Device: Total knee arthroplasty implanted with standard guides.

• Registration Number: NCT03865524
• Lead Sponsor: Pedro-José Torrijos-Garrido

Brief 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.

Study Timeline

• Study Start: 2019-02-07
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Total knee arthroplasty implanted with GPS navigation system	Total knee arthroplasty implanted with GPS navigation system.
Control	Total knee arthroplasty implanted with standard guides.	Total knee arthroplasty implanted with standard guides.

Primary Outcome Measures

Name	Time	Method
Deviation in a mechanical axis of knees	12 months	Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º

Secondary Outcome Measures

Name	Time	Method
Surgical procedure time	Week 1	Surgical time
Number of Surgical complications (post-operative)	1-12 months	postoperative complications
Radiological axes (femoral)	12 months	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).
Radiological axes (tibial)	12 months	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).
Admission (hospital) duration	Week 1	Number of days of the hospital admission
Number of Surgical complications (perioperative)	1 to 6 weeks	perioperative complications
Number of Surgical complications (Intraoperative)	Week 1	Intraoperative complications

Trial Locations

Locations (2)

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario Santa Cristina; 🇪🇸 Madrid, Spain