Arthropathy of Knee, Obesity, Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty
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.
Interventions
DEVICETotal knee arthroplasty implanted with GPS navigation system
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
DEVICETotal knee arthroplasty implanted with standard guides.
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
Sponsors
Pedro-José Torrijos-Garrido
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Multicenter, prospective trial with a CE-marked medical device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical procedure time | Week 1 | Surgical time |
| Number of Surgical complications (Intraoperative) | Week 1 | Intraoperative complications |
| Number of Surgical complications (perioperative) | 1 to 6 weeks | perioperative complications |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogic Scale for pain | 1-12 months | 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. |
| Knee Society Score Questionaire | 6 weeks-12 months | 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. |
| Range of Motion | 6 weeks-12 months | The maximum extension and flexion |
Countries
Spain
Contacts
Primary ContactPedro José Torrijos Garrido, MD, PhD
Backup ContactConcepción Payares Herrera, MD
Outcome results
None listed