PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- the profile spine parameters: apex lumbar position
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
EOS™ Acquisition
Intervention: EOS™ Acquisition (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported