Study Results
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Basic Information
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COMPLETED
161 participants
OBSERVATIONAL
2011-05-31
2013-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EOS™ Acquisition
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Jean-Charles LE HUEC, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Antoine BENARD, MD
Role: STUDY_CHAIR
University Hospital, Bordeaux
Locations
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Spine Unit 2, University Hospital
Bordeaux, , France
Countries
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References
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Borenstein D. Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tournier C, Aunoble S, Le Huec JC, Lemaire JP, Tropiano P, Lafage V, Skalli W. Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. Eur Spine J. 2007 Mar;16(3):411-21. doi: 10.1007/s00586-006-0208-7. Epub 2006 Sep 8.
Other Identifiers
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CHUBX 2010/26
Identifier Type: -
Identifier Source: org_study_id
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