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Spine Reference Parameters on EOS Imaging (EOS-SPINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406743
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

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

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.

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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. the profile spine parameters: apex lumbar position [ Time Frame: 1 day ]
  2. the lordosis lower angle, back type according to the ROUSSOULY [ Time Frame: 1 day ]
  3. the sagittal balance parameters [ Time Frame: 1 day ]
  4. the lordosis upper angle, back type according to the ROUSSOULY [ Time Frame: 1 day ]
  5. the pelvis parameters [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subject without spine pathology

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01406743

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Spine Unit 2, University Hospital
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Jean-Charles LE HUEC, PU-PH University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux Identifier: NCT01406743    
Other Study ID Numbers: CHUBX 2010/26
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by University Hospital, Bordeaux:
Spine and pelvis parameters
Sagittal balance