Spine Reference Parameters on EOS Imaging (NCT01406743) | Clinical Trial Compass
CompletedNot Applicable
Spine Reference Parameters on EOS Imaging
France161 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used EOS imaging to measure spinal shape and pelvic alignment in healthy volunteers — if I were to have EOS imaging done, how would my own spine measurements compare to the reference values established in a study like this one?
2Since this study focused on classifying back types using the Roussouly classification system, is it worth asking whether my spine falls into one of those categories, and what that might mean for my treatment options?
3This trial is completed and involved only healthy volunteers rather than patients with a spine condition — does that mean the findings are mainly used as a baseline for comparison, and how might my doctor use that kind of reference data when evaluating my spine?
4EOS imaging captures full-body spinal and pelvic alignment in a standing position — is this type of imaging something my care team would consider for me, and would it change how they understand my condition compared to standard X-rays?
5Since this study measured sagittal balance, which refers to how the spine is aligned from front to back when standing, is my own sagittal balance something my doctor has assessed, and could it be relevant to any treatment decisions being considered for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the profile spine parameters: apex lumbar position
Timeframe: 1 day
2
the lordosis lower angle, back type according to the ROUSSOULY
Timeframe: 1 day
3
the sagittal balance parameters
Timeframe: 1 day
4
the lordosis upper angle, back type according to the ROUSSOULY