Spine Reference Parameters on EOS Imaging (EOS-SPINE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01406743
First received: July 28, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001).

The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.

However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population.

So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.


Condition Intervention
Healthy Volunteers
Device: EOS™ Acquisition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • the profile spine parameters: apex lumbar position [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • the lordosis lower angle, back type according to the ROUSSOULY [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • the sagittal balance parameters [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • the lordosis upper angle, back type according to the ROUSSOULY [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • the pelvis parameters [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EOS™ Acquisition Device: EOS™ Acquisition
Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.

Detailed Description:

The main objective of this study is to describe thoraco-lumbar spine characteristics, obtained by EOS ™technology, in a reference population, not presenting spine pathology. It's a monocentric transverse descriptive study. This study allows creating a database of the spine, pelvis and sagittal balance parameters to asymptomatic subjects according to age brackets.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

subject without spine pathology

Criteria

Inclusion Criteria:

  • Subjects of more than 18 years old
  • Both genders
  • Woman under efficient contraception (if not menopause)
  • EVA < 2 for the rachis (lumbar vertebra and radiculaire),
  • Score ODI ≤ 20 %
  • Given informed consent
  • Subject with French health system

Exclusion Criteria:

  • Pregnant or feeding women
  • Subject having a follow-up of the back or a regular back pain,
  • Subject presenting lower limbs pathology which can have an echo on the rachis such as a length disparity or a flexum
  • Subject with spine and pelvis surgery antecedents.
  • Person placed under protection of justice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406743

Contacts
Contact: Jean-Charles LE HUEC, PU-PH + 335 56 79 55 90 jean-charles.lehuec@chu-bordeaux.fr
Contact: Elodie SERIS +33 557 1028 95 elodie.seris@chu-bordeaux.fr

Locations
France
Spine Unit 2, University Hospital Recruiting
Bordeaux, France, 33076
Principal Investigator: Jean-Charles LE HUEC, PU-PH         
Sub-Investigator: Frederic SIBILLA, MD         
Sub-Investigator: Stéphane AUNOBLE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-Charles LE HUEC, PU-PH University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01406743     History of Changes
Other Study ID Numbers: CHUBX 2010/26
Study First Received: July 28, 2011
Last Updated: November 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Spine and pelvis parameters
Sagittal balance
Database

ClinicalTrials.gov processed this record on October 29, 2014