Spine Reference Parameters on EOS Imaging

NCT01406743 | Completed

• 1 other identifier: CHUBX 2010/26
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Spine and pelvis parameters; Sagittal balance; Database

Outcome Measures

Primary Outcomes (5)

• the profile spine parameters: apex lumbar position

  1 day

• the lordosis lower angle, back type according to the ROUSSOULY

  1 day

• the sagittal balance parameters

  1 day

• the lordosis upper angle, back type according to the ROUSSOULY

  1 day

• the pelvis parameters

  1 day

Study Arms (1)

EOS™ Acquisition

Device: EOS™ Acquisition

Interventions

EOS™ Acquisition DEVICE

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

EOS™ Acquisition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subject without spine pathology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Spine Unit 2, University Hospital

Bordeaux, 33076, France

Location

Related Publications (16)

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  PMID: 1829622 BACKGROUND

• 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.

  PMID: 18046031 BACKGROUND

• 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.

  PMID: 1830688 BACKGROUND

• 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.

  PMID: 16114859 BACKGROUND

• 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.

  PMID: 9662585 BACKGROUND

• 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.

  PMID: 11725230 BACKGROUND

• 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.

  PMID: 12594558 BACKGROUND

• 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.

  PMID: 16413443 BACKGROUND

• 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.

  PMID: 12961040 BACKGROUND

• 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.

  PMID: 9629932 BACKGROUND

• 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.

  PMID: 17334293 BACKGROUND

• 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.

  PMID: 2969044 BACKGROUND

• 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.

  PMID: 14699309 BACKGROUND

• 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.

  PMID: 2940707 BACKGROUND

• 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.

  PMID: 2961086 BACKGROUND

• 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.

  PMID: 16960704 BACKGROUND

Study Officials

• Jean-Charles LE HUEC, PU-PH

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 1, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

FR (1)