Spine Reference Parameters on EOS Imaging - Full Text View

Purpose

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.

Condition	Intervention
Healthy Volunteers	Device: EOS™ Acquisition

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

the profile spine parameters: apex lumbar position [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the lordosis lower angle, back type according to the ROUSSOULY [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the sagittal balance parameters [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the lordosis upper angle, back type according to the ROUSSOULY [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the pelvis parameters [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	204
Study Start Date:	May 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
EOS™ Acquisition	Device: 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

subject without spine pathology

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406743

Contacts

Contact: Jean-Charles LE HUEC, PU-PH	+ 335 56 79 55 90	jean-charles.lehuec@chu-bordeaux.fr
Contact: Elodie SERIS	+33 557 1028 95	elodie.seris@chu-bordeaux.fr

Locations

France
Spine Unit 2, University Hospital	Recruiting
Bordeaux, France, 33076
Principal Investigator: Jean-Charles LE HUEC, PU-PH
Sub-Investigator: Frederic SIBILLA, MD
Sub-Investigator: Stéphane AUNOBLE, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:	Jean-Charles LE HUEC, PU-PH	University Hospital, Bordeaux
Study Chair:	Antoine BENARD, MD	University Hospital, Bordeaux

More Information

Publications:

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

Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review. 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.

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. Review. 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.

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. 2001 Dec 1;26(23):2521-32; discussion 2532-4.

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. 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.

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

Legaye J, Duval-Beaupère 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.

Pellisé F, Hernández A, Vidal X, Minguell J, Martínez 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.

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.

[No authors listed] 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. Review. 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. Epub 2006 Sep 8.

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT01406743 History of Changes
Other Study ID Numbers:	CHUBX 2010/26
Study First Received:	July 28, 2011
Last Updated:	May 17, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

Spine and pelvis parameters
Sagittal balance
Database

ClinicalTrials.gov processed this record on May 23, 2013

Spine Reference Parameters on EOS Imaging (EOS-SPINE)