Skip to main content
OpenTrials
Completed

NCT Number: NCT03865524

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Arthropathy of Knee Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Santa Cristina, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty implanted with GPS navigation system

Device

Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment

Total knee arthroplasty implanted with standard guides.

Device

Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides

Primary outcomes

  1. Deviation in a mechanical axis of knees

    Time frame: 12 months

    Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º

Secondary outcomes

  1. Radiological axes (femoral)

    Time frame: 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).

  2. Radiological axes (tibial)

    Time frame: 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).

  3. Surgical procedure time

    Time frame: Week 1

    Surgical time

  4. Admission (hospital) duration

    Time frame: Week 1

    Number of days of the hospital admission

  5. Number of Surgical complications (Intraoperative)

    Time frame: Week 1

    Intraoperative complications

  6. Number of Surgical complications (perioperative)

    Time frame: 1 to 6 weeks

    perioperative complications

  7. Number of Surgical complications (post-operative)

    Time frame: 1-12 months

    postoperative complications

Other outcomes

  1. Knee Society Score Questionaire

    Time frame: 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.

  2. Range of Motion

    Time frame: 6 weeks-12 months

    The maximum extension and flexion

  3. Visual Analogic Scale for pain

    Time frame: 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".

Interested in participating?

Completed

Looking for future studies?

Notify Me

Sponsors and collaborators

Lead sponsor

Pedro-José Torrijos-Garrido

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2019
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.