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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Total knee arthroplasty implanted with GPS navigation system. |
|
| Control | Active Comparator | Total knee arthroplasty implanted with standard guides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty implanted with GPS navigation system | Device | Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score Questionaire | KSS Questionaire, developed by the Knee Society, assesses the function of the knee replacement and the functional capabilities of patients after their implantation. It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro José Torrijos Garrido, MD, PhD | Contact | +34 91 191 74 85 | pedrojose.torrijos@salud.madrid.org | |
| Concepción Payares Herrera, MD | Contact | +34 91 191 70 70 | cpayares@idiphim.org |
| Name | Affiliation | Role |
|---|---|---|
| Pedro José Torrijos Garrido, MD, PhD | Hospital Universitario Puerta de Hierro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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Randomized, Multicenter, prospective trial with a CE-marked medical device
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| Total knee arthroplasty implanted with standard guides. | Device | Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides |
|
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 |
| 6 weeks-12 months |
| Range of Motion | The maximum extension and flexion | 6 weeks-12 months |
| Visual Analogic Scale for pain | VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain". | 1-12 months |
| Hospital Universitario Santa Cristina | Recruiting | Madrid | 28009 | Spain |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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