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

Primary Purpose

Osteoarthritis, Knee, Obesity, Arthropathy of Knee

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Total knee arthroplasty implanted with GPS navigation system

Total knee arthroplasty implanted with standard guides.

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Hospital Universitario Santa CristinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Total knee arthroplasty implanted with GPS navigation system.

Total knee arthroplasty implanted with standard guides.

Outcomes

Primary Outcome Measures

Deviation in a mechanical axis of knees

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

Secondary Outcome Measures

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).

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).

Surgical procedure time

Surgical time

Admission (hospital) duration

Number of days of the hospital admission

Number of Surgical complications (Intraoperative)

Intraoperative complications

Number of Surgical complications (perioperative)

perioperative complications

Number of Surgical complications (post-operative)

postoperative complications

Full Information

NCT ID

NCT03865524

First Posted

March 5, 2019

Last Updated

April 19, 2022

Sponsor

Pedro-José Torrijos-Garrido

1. Study Identification

Unique Protocol Identification Number

NCT03865524

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pedro-José Torrijos-Garrido

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Obesity, Arthropathy of Knee

Keywords

Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, Multicenter, prospective trial with a CE-marked medical device

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Total knee arthroplasty implanted with GPS navigation system.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Total knee arthroplasty implanted with standard guides.

Intervention Type

Device

Intervention Name(s)

Total knee arthroplasty implanted with GPS navigation system

Intervention Description

Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment

Intervention Type

Device

Intervention Name(s)

Total knee arthroplasty implanted with standard guides.

Intervention Description

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

Primary Outcome Measure Information:

Title

Deviation in a mechanical axis of knees

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Radiological axes (femoral)

Description

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).

Time Frame

12 months

Title

Radiological axes (tibial)

Description

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).

Time Frame

12 months

Title

Surgical procedure time

Description

Surgical time

Time Frame

Week 1

Title

Admission (hospital) duration

Description

Number of days of the hospital admission

Time Frame

Week 1

Title

Number of Surgical complications (Intraoperative)

Description

Intraoperative complications

Time Frame

Week 1

Title

Number of Surgical complications (perioperative)

Description

perioperative complications

Time Frame

1 to 6 weeks

Title

Number of Surgical complications (post-operative)

Description

postoperative complications

Time Frame

1-12 months

Other Pre-specified Outcome Measures:

Title

Knee Society Score Questionaire

Description

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.

Time Frame

6 weeks-12 months

Title

Range of Motion

Description

The maximum extension and flexion

Time Frame

6 weeks-12 months

Title

Visual Analogic Scale for pain

Description

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".

Time Frame

1-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro José Torrijos Garrido, MD, PhD

Phone

+34 91 191 74 85

pedrojose.torrijos@salud.madrid.org

First Name & Middle Initial & Last Name or Official Title & Degree

Concepción Payares Herrera, MD

Phone

+34 91 191 70 70

cpayares@idiphim.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro José Torrijos Garrido, MD, PhD

Organizational Affiliation

Hospital Universitario Puerta de Hierro

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Puerta de Hierro Majadahonda

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro José Torrijos Garrido, MD, PhD

Phone

+34 91 191 74 85

pedrojose.torrijos@salud.madrid.org

Facility Name

Hospital Universitario Santa Cristina

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paloma Aragonés Maza, MD

Phone

+34 91 191 74 85

paloma.aragones@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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