Clinical trial NCT03865524: Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
Official title: Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Obesity
Arthropathy of Knee
Keywords: Osteoarthritis, Knee
Obesity
Knee replacement
Arthroplasty
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Multicenter, prospective trial with a CE-marked medical device
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deviation in a mechanical axis of knees
timeFrame: 12 months
Secondary outcomes:
measure: Radiological axes (femoral)
timeFrame: 12 months
measure: Radiological axes (tibial)
timeFrame: 12 months
measure: Surgical procedure time
timeFrame: Week 1
measure: Admission (hospital) duration
timeFrame: Week 1
measure: Number of Surgical complications (Intraoperative)
timeFrame: Week 1
measure: Number of Surgical complications (perioperative)
timeFrame: 1 to 6 weeks
measure: Number of Surgical complications (post-operative)
timeFrame: 1-12 months
Other outcomes:
measure: Knee Society Score Questionaire
timeFrame: 6 weeks-12 months
measure: Range of Motion
timeFrame: 6 weeks-12 months
measure: Visual Analogic Scale for pain
timeFrame: 1-12 months
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Santa Cristina
Study officials:
affiliation: Hospital Universitario Puerta de Hierro
name: Pedro José Torrijos Garrido, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: