Spine Reference Parameters on EOS Imaging (EOS-SPINE)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™|
- 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 ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406743
|Contact: Jean-Charles LE HUEC, PU-PH||+ 335 56 79 55 firstname.lastname@example.org|
|Contact: Elodie SERIS||+33 557 1028 email@example.com|
|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|
|Principal Investigator:||Jean-Charles LE HUEC, PU-PH||University Hospital, Bordeaux|
|Study Chair:||Antoine BENARD, MD||University Hospital, Bordeaux|