NCT03865524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5.4 years

First QC Date

March 5, 2019

Last Update Submit

November 27, 2023

Conditions

Osteoarthritis, KneeObesityArthropathy of Knee

Keywords

Osteoarthritis, KneeObesityKnee replacementArthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Radiological axes (femoral)

    12 months

  • Radiological axes (tibial)

    12 months

  • Surgical procedure time

    Week 1

  • Admission (hospital) duration

    Week 1

  • Number of Surgical complications (Intraoperative)

    Week 1

  • +2 more secondary outcomes

Other Outcomes (3)

  • Knee Society Score Questionaire

    6 weeks-12 months

  • Range of Motion

    6 weeks-12 months

  • Visual Analogic Scale for pain

    1-12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Total knee arthroplasty implanted with GPS navigation system.

Device: Total knee arthroplasty implanted with GPS navigation system

Control

ACTIVE COMPARATOR

Total knee arthroplasty implanted with standard guides.

Device: Total knee arthroplasty implanted with standard guides.

Interventions

Total knee arthroplasty implanted with GPS navigation systemDEVICE

Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment

Experimental
Total knee arthroplasty implanted with standard guides.DEVICE

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Santa Cristina

Madrid, 28009, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeObesity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro José Torrijos Garrido, MD, PhD

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro José Torrijos Garrido, MD, PhD

CONTACT

+34 91 191 74 85pedrojose.torrijos@salud.madrid.org

Concepción Payares Herrera, MD

CONTACT

+34 91 191 70 70cpayares@idiphim.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Multicenter, prospective trial with a CE-marked medical device
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 7, 2019

Study Start

February 7, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)