AzTrials
AzTrials

Healthy VolunteersEOS-SPINENCT01406743

Spine Reference Parameters on EOS Imaging

A study testing EOS™ Acquisition in people with Healthy Volunteers, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
EOS™ Acquisition
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteFrance
Study dates
May 2011to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Spine Unit 2, University Hospital

    Bordeaux, 33076

Other trials in France

About this study

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

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.

Read more

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.

Read the 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.

Being tested
EOS™ Acquisition
Keywords
Spine and pelvis parameters, Sagittal balance, Database

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EOS™ AcquisitionDevice

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

Study groups in NCT01406743
Study groupRoleWhat they receive
EOS™ AcquisitionExperimentalNot described
Receives: Device: EOS™ Acquisition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the profile spine parameters: apex lumbar position

    Measured: 1 day

  2. the lordosis lower angle, back type according to the ROUSSOULY

    Measured: 1 day

  3. the sagittal balance parameters

    Measured: 1 day

  4. the lordosis upper angle, back type according to the ROUSSOULY

    Measured: 1 day

  5. the pelvis parameters

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01406743
Sponsor's protocol ID
CHUBX 2010/26
Other IDs
2010-A01248-31
Acronym
EOS-SPINE
Status last verified
Jan 2015
First submitted
28 Jul 2011
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • Borenstein D. Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17.

    PubMed 1829622

  • Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

    PubMed 18046031

  • Cats-Baril WL, Frymoyer JW. Identifying patients at risk of becoming disabled because of low-back pain. The Vermont Rehabilitation Engineering Center predictive model. Spine (Phila Pa 1976). 1991 Jun;16(6):605-7. doi: 10.1097/00007632-199106000-00001.

    PubMed 1830688

  • Dubousset J, Charpak G, Dorion I, Skalli W, Lavaste F, Deguise J, Kalifa G, Ferey S. [A new 2D and 3D imaging approach to musculoskeletal physiology and pathology with low-dose radiation and the standing position: the EOS system]. Bull Acad Natl Med. 2005 Feb;189(2):287-97; discussion 297-300. French.

    PubMed 16114859

  • Kalifa G, Charpak Y, Maccia C, Fery-Lemonnier E, Bloch J, Boussard JM, Attal M, Dubousset J, Adamsbaum C. Evaluation of a new low-dose digital x-ray device: first dosimetric and clinical results in children. Pediatr Radiol. 1998 Jul;28(7):557-61. doi: 10.1007/s002470050413.

    PubMed 9662585

  • Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.

    PubMed 11725230

  • Geijer H, Verdonck B, Beckman KW, Andersson T, Persliden J. Digital radiography of scoliosis with a scanning method: radiation dose optimization. Eur Radiol. 2003 Mar;13(3):543-51. doi: 10.1007/s00330-002-1476-1. Epub 2002 Jun 14.

    PubMed 12594558

  • Glassman S, Gornet MF, Branch C, Polly D Jr, Peloza J, Schwender JD, Carreon L. MOS short form 36 and Oswestry Disability Index outcomes in lumbar fusion: a multicenter experience. Spine J. 2006 Jan-Feb;6(1):21-6. doi: 10.1016/j.spinee.2005.09.004.

    PubMed 16413443

  • Hansen J, Jurik AG, Fiirgaard B, Egund N. Optimisation of scoliosis examinations in children. Pediatr Radiol. 2003 Nov;33(11):752-65. doi: 10.1007/s00247-003-1015-5. Epub 2003 Sep 5.

    PubMed 12961040

  • Legaye J, Duval-Beaupere G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103. doi: 10.1007/s005860050038.

    PubMed 9629932

  • Pellise F, Hernandez A, Vidal X, Minguell J, Martinez C, Villanueva C. Radiologic assessment of all unfused lumbar segments 7.5 years after instrumented posterior spinal fusion. Spine (Phila Pa 1976). 2007 Mar 1;32(5):574-9. doi: 10.1097/01.brs.0000256875.17765.e6.

    PubMed 17334293

  • Rossignol M, Suissa S, Abenhaim L. Working disability due to occupational back pain: three-year follow-up of 2,300 compensated workers in Quebec. J Occup Med. 1988 Jun;30(6):502-5.

    PubMed 2969044

  • Roussouly P, Berthonnaud E, Dimnet J. [Geometrical and mechanical analysis of lumbar lordosis in an asymptomatic population: proposed classification]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):632-9. French.

    PubMed 14699309

  • Spengler DM, Bigos SJ, Martin NA, Zeh J, Fisher L, Nachemson A. Back injuries in industry: a retrospective study. I. Overview and cost analysis. Spine (Phila Pa 1976). 1986 Apr;11(3):241-5. doi: 10.1097/00007632-198604000-00010.

    PubMed 2940707

  • Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976). 1987 Sep;12(7 Suppl):S1-59. No abstract available.

    PubMed 2961086

Questions about this trial

What is this clinical trial studying?

A study testing EOS™ Acquisition in people with Healthy Volunteers, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the profile spine parameters: apex lumbar position (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01406743, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Spine Reference Parameters on EOS Imaging | AzTrials