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

July 28, 2011
November 18, 2013
May 2011
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01406743 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Spine Reference Parameters on EOS Imaging
PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

subject without spine pathology

Healthy Volunteers
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.
EOS™ Acquisition
Intervention: Device: EOS™ Acquisition

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
204
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
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
France
 
NCT01406743
CHUBX 2010/26
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Jean-Charles LE HUEC, PU-PH University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
University Hospital, Bordeaux
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP