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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865524
• Other study ID #: NAOBE
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Puerta de Hierro University Hospital
• Contact: Pedro José Torrijos Garrido, MD, PhD
• Phone: +34 91 191 74 85
• Email: pedrojose.torrijos[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total knee arthroplasty implanted with GPS navigation system
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
• Total knee arthroplasty implanted with standard guides.
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides

Locations

Country	Name	City	State
Spain	Hospital Universitario Santa Cristina	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pedro-José Torrijos-Garrido

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Range of Motion	The maximum extension and flexion	6 weeks-12 months
Other	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
Primary	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	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 (a).	12 months
Secondary	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 (ß).	12 months
Secondary	Surgical procedure time	Surgical time	Week 1
Secondary	Admission (hospital) duration	Number of days of the hospital admission	Week 1
Secondary	Number of Surgical complications (Intraoperative)	Intraoperative complications	Week 1
Secondary	Number of Surgical complications (perioperative)	perioperative complications	1 to 6 weeks
Secondary	Number of Surgical complications (post-operative)	postoperative complications	1-12 months