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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Osteoarthritis, Knee; Arthropathy of Knee
• Intervention / Treatment: Device: Total knee arthroplasty implanted with GPS navigation system; Device: Total knee arthroplasty implanted with standard guides.

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.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Jose Torrijos Garrido, MD, PhD; Phone Number: +34 91 191 74 85; Email: pedrojose.torrijos@salud.madrid.org
• Study Contact Backup: Name: Concepción Payares Herrera, MD; Phone Number: +34 91 191 70 70; Email: cpayares@idiphim.org

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Universitario Santa Cristina
    • Contact: Paloma Aragonés Maza, MD; Phone Number: +34 91 191 74 85; Email: paloma.aragones@salud.madrid.org
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro Majadahonda
      • Contact: Pedro Jose Torrijos Garrido, MD, PhD; Phone Number: +34 91 191 74 85; Email: pedrojose.torrijos@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Pedro-José Torrijos-Garrido
• Investigators: Principal Investigator: Pedro José Torrijos Garrido, MD, PhD, Hospital Universitario Puerta de Hierro

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Arthroplasty; Knee replacement; Osteoarthritis, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NAOBE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No