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Completed

NCT Number: NCT01406743

Spine Reference Parameters on EOS Imaging

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Unit 2, University Hospital

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS™ Acquisition

Device

Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

Acronym: EOS-SPINE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 1, 2011
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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