Spine Reference Parameters on EOS Imaging (EOS-SPINE)
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|ClinicalTrials.gov Identifier: NCT01406743|
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : January 14, 2015
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 or disease||Intervention/treatment|
|Healthy Volunteers||Device: EOS™ Acquisition|
|Study Type :||Observational|
|Actual Enrollment :||161 participants|
|Official Title:||PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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 profile spine parameters: apex lumbar position [ Time Frame: 1 day ]
- the lordosis lower angle, back type according to the ROUSSOULY [ Time Frame: 1 day ]
- the sagittal balance parameters [ Time Frame: 1 day ]
- the lordosis upper angle, back type according to the ROUSSOULY [ Time Frame: 1 day ]
- the pelvis parameters [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406743
|Spine Unit 2, University Hospital|
|Bordeaux, France, 33076|
|Principal Investigator:||Jean-Charles LE HUEC, PU-PH||University Hospital, Bordeaux|
|Study Chair:||Antoine BENARD, MD||University Hospital, Bordeaux|