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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Obesity, Arthropathy of Knee

Intervention / Treatment
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* Device: Total knee arthroplasty implanted with GPS navigation system
* Device: Total knee arthroplasty implanted with standard guides.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Multicenter, prospective trial with a CE-marked medical device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Total knee arthroplasty implanted with GPS navigation system. | Device: Total knee arthroplasty implanted with GPS navigation system<br>* Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment<br>|
| Active Comparator: Control<br>Total knee arthroplasty implanted with standard guides. | Device: Total knee arthroplasty implanted with standard guides.<br>* Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation in a mechanical axis of knees | Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 12 months | 
| Surgical procedure time | Surgical time | Week 1 | 
| Admission (hospital) duration | Number of days of the hospital admission | Week 1 | 
| Number of Surgical complications (Intraoperative) | Intraoperative complications | Week 1 | 
| Number of Surgical complications (perioperative) | perioperative complications | 1 to 6 weeks | 
| Number of Surgical complications (post-operative) | postoperative complications | 1-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty