Postural Balance of the Adult

NCT ID: NCT00926432

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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Description of the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural troubles

Detailed Description

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In clinical routine, 3D analysis of postural balance is only made using clinical examination. When dealing with specific pathologies, in particular spine disorders, a better understanding of the balance could help better treat and prevent late complications. This prospective study aims at describing the pathologies of the musculoskeletal system using 3D reconstruction of the spine, the pelvis and the inferior limbs with regard to gravity line by patients suffering from postural trouble and defining new parameters to assess postural balance

Conditions

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Postural Balance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Small group of aged healthy volunteers

Group Type OTHER

EOS™ Acquisition

Intervention Type DEVICE

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

Patients

Patients consulting for spine disorders that may or may not have postural troubles

Group Type OTHER

EOS™ Acquisition

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Affiliated to social insurance
* Informed of the benefits, the risks and the conduction of the study and have given their free informed consent.

For Patients

* Medical prescription for an EOS™ exam, or for Frontal AND Lateral full-spine radiographs or for a pangonogram.

For Healthy Volunteers

* 50 years old

Exclusion Criteria

For Patients

* Patients that neither need any EOS™ exam, nor Face \& Lateral full-spine radiographs, nor pangonogram.

For Healthy Volunteers

* Children or young adults (\<50)
* Psychiatric or neurologic deficit.
* Anterior Surgery of Spine or inferior Member
* Chronic back pain
* Recent acute back Pain
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EOS imaging Inc.

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Marc VITAL, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospital University, Bordeaux

Wafa SKALLI, PhD, Pr

Role: STUDY_DIRECTOR

Laboratoire de Biomécanique Arts et Metiers ParisTech-CNRS UMR 8005

Locations

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Unité de Pathologie Rachidienne Tripode CHU Pellegrin, Place Amélie Raba-Léon

Bordeaux, , France

Site Status

Countries

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France

References

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Dubousset J, Charpak G, Skalli W, Kalifa G, Lazennec JY. [EOS stereo-radiography system: whole-body simultaneous anteroposterior and lateral radiographs with very low radiation dose]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Oct;93(6 Suppl):141-3. doi: 10.1016/s0035-1040(07)92729-4. No abstract available. French.

Reference Type BACKGROUND
PMID: 18033112 (View on PubMed)

Schwab F, Lafage V, Boyce R, Skalli W, Farcy JP. Gravity line analysis in adult volunteers: age-related correlation with spinal parameters, pelvic parameters, and foot position. Spine (Phila Pa 1976). 2006 Dec 1;31(25):E959-67. doi: 10.1097/01.brs.0000248126.96737.0f.

Reference Type BACKGROUND
PMID: 17139212 (View on PubMed)

Skalli W, Zeller RD, Miladi L, Bourcereau G, Savidan M, Lavaste F, Dubousset J. Importance of pelvic compensation in posture and motion after posterior spinal fusion using CD instrumentation for idiopathic scoliosis. Spine (Phila Pa 1976). 2006 May 20;31(12):E359-66. doi: 10.1097/01.brs.0000219402.01636.87.

Reference Type BACKGROUND
PMID: 16721280 (View on PubMed)

El Fegoun AB, Schwab F, Gamez L, Champain N, Skalli W, Farcy JP. Center of gravity and radiographic posture analysis: a preliminary review of adult volunteers and adult patients affected by scoliosis. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1535-40. doi: 10.1097/01.brs.0000167534.49069.e9.

Reference Type BACKGROUND
PMID: 15990669 (View on PubMed)

Rillardon L, Campana S, Mitton D, Skalli W, Feydy A. [Evaluation of the intervertebral disc spaces with a low dose radiographic system]. J Radiol. 2005 Mar;86(3):311-9. doi: 10.1016/s0221-0363(05)81360-5. French.

Reference Type BACKGROUND
PMID: 15908871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16114859 (View on PubMed)

Vialle R, Levassor N, Rillardon L, Templier A, Skalli W, Guigui P. Radiographic analysis of the sagittal alignment and balance of the spine in asymptomatic subjects. J Bone Joint Surg Am. 2005 Feb;87(2):260-7. doi: 10.2106/JBJS.D.02043.

Reference Type BACKGROUND
PMID: 15687145 (View on PubMed)

Parent S, Labelle H, Skalli W, de Guise J. Vertebral wedging characteristic changes in scoliotic spines. Spine (Phila Pa 1976). 2004 Oct 15;29(20):E455-62. doi: 10.1097/01.brs.0000142430.65463.3a.

Reference Type BACKGROUND
PMID: 15480123 (View on PubMed)

Faro FD, Marks MC, Pawelek J, Newton PO. Evaluation of a functional position for lateral radiograph acquisition in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2284-9. doi: 10.1097/01.brs.0000142224.46796.a7.

Reference Type BACKGROUND
PMID: 15480143 (View on PubMed)

Steib JP, Dumas R, Mitton D, Skalli W. Surgical correction of scoliosis by in situ contouring: a detorsion analysis. Spine (Phila Pa 1976). 2004 Jan 15;29(2):193-9. doi: 10.1097/01.BRS.0000107233.99835.A4.

Reference Type BACKGROUND
PMID: 14722414 (View on PubMed)

Gangnet N, Pomero V, Dumas R, Skalli W, Vital JM. Variability of the spine and pelvis location with respect to the gravity line: a three-dimensional stereoradiographic study using a force platform. Surg Radiol Anat. 2003 Nov-Dec;25(5-6):424-33. doi: 10.1007/s00276-003-0154-6. Epub 2003 Sep 16.

Reference Type BACKGROUND
PMID: 13680185 (View on PubMed)

Dumas R, Steib JP, Mitton D, Lavaste F, Skalli W. Three-dimensional quantitative segmental analysis of scoliosis corrected by the in situ contouring technique. Spine (Phila Pa 1976). 2003 Jun 1;28(11):1158-62. doi: 10.1097/01.BRS.0000068242.29809.D0.

Reference Type BACKGROUND
PMID: 12782985 (View on PubMed)

Rajnics P, Templier A, Skalli W, Lavaste F, Illes T. The association of sagittal spinal and pelvic parameters in asymptomatic persons and patients with isthmic spondylolisthesis. J Spinal Disord Tech. 2002 Feb;15(1):24-30. doi: 10.1097/00024720-200202000-00004.

Reference Type BACKGROUND
PMID: 11891447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9629932 (View on PubMed)

Jackson RP, Peterson MD, McManus AC, Hales C. Compensatory spinopelvic balance over the hip axis and better reliability in measuring lordosis to the pelvic radius on standing lateral radiographs of adult volunteers and patients. Spine (Phila Pa 1976). 1998 Aug 15;23(16):1750-67. doi: 10.1097/00007632-199808150-00008.

Reference Type BACKGROUND
PMID: 9728376 (View on PubMed)

Gelb DE, Lenke LG, Bridwell KH, Blanke K, McEnery KW. An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1351-8.

Reference Type BACKGROUND
PMID: 7676332 (View on PubMed)

Mitton D, Zhao K, Bertrand S, Zhao C, Laporte S, Yang C, An KN, Skalli W. 3D reconstruction of the ribs from lateral and frontal X-rays in comparison to 3D CT-scan reconstruction. J Biomech. 2008;41(3):706-10. doi: 10.1016/j.jbiomech.2007.09.034. Epub 2007 Nov 5.

Reference Type BACKGROUND
PMID: 17981286 (View on PubMed)

Rousseau MA, Laporte S, Chavary-Bernier E, Lazennec JY, Skalli W. Reproducibility of measuring the shape and three-dimensional position of cervical vertebrae in upright position using the EOS stereoradiography system. Spine (Phila Pa 1976). 2007 Nov 1;32(23):2569-72. doi: 10.1097/BRS.0b013e318158cba2.

Reference Type BACKGROUND
PMID: 17978655 (View on PubMed)

Gille O, Champain N, Benchikh-El-Fegoun A, Vital JM, Skalli W. Reliability of 3D reconstruction of the spine of mild scoliotic patients. Spine (Phila Pa 1976). 2007 Mar 1;32(5):568-73. doi: 10.1097/01.brs.0000256866.25747.b3.

Reference Type BACKGROUND
PMID: 17334292 (View on PubMed)

Hemophilia: state of the art in 1982. Vox Sang. 1983;45(1):93-5. doi: 10.1159/000466070. No abstract available.

Reference Type BACKGROUND
PMID: 6880151 (View on PubMed)

Dumas R, Aissaoui R, Mitton D, Skalli W, de Guise JA. Personalized body segment parameters from biplanar low-dose radiography. IEEE Trans Biomed Eng. 2005 Oct;52(10):1756-63. doi: 10.1109/TBME.2005.855711.

Reference Type BACKGROUND
PMID: 16235661 (View on PubMed)

Le Bras A, Laporte S, Bousson V, Mitton D, De Guise JA, Laredo JD, Skalli W. 3D reconstruction of the proximal femur with low-dose digital stereoradiography. Comput Aided Surg. 2004;9(3):51-7. doi: 10.3109/10929080400018122.

Reference Type BACKGROUND
PMID: 15792937 (View on PubMed)

Pomero V, Mitton D, Laporte S, de Guise JA, Skalli W. Fast accurate stereoradiographic 3D-reconstruction of the spine using a combined geometric and statistic model. Clin Biomech (Bristol). 2004 Mar;19(3):240-7. doi: 10.1016/j.clinbiomech.2003.11.014.

Reference Type BACKGROUND
PMID: 15003338 (View on PubMed)

Parent S, Labelle H, Skalli W, de Guise J. Thoracic pedicle morphometry in vertebrae from scoliotic spines. Spine (Phila Pa 1976). 2004 Feb 1;29(3):239-48. doi: 10.1097/01.brs.0000109995.64028.fe.

Reference Type BACKGROUND
PMID: 14752344 (View on PubMed)

Dumas R, Le Bras A, Champain N, Savidan M, Mitton D, Kalifa G, Steib JP, de Guise JA, Skalli W. Validation of the relative 3D orientation of vertebrae reconstructed by bi-planar radiography. Med Eng Phys. 2004 Jun;26(5):415-22. doi: 10.1016/j.medengphy.2004.02.004.

Reference Type BACKGROUND
PMID: 15147749 (View on PubMed)

Le Bras A, Laporte S, Mitton D, de Guise JA, Skalli W. 3D detailed reconstruction of vertebrae with low dose digital stereoradiography. Stud Health Technol Inform. 2002;91:286-90.

Reference Type BACKGROUND
PMID: 15457739 (View on PubMed)

Laporte S, Skalli W, de Guise JA, Lavaste F, Mitton D. A biplanar reconstruction method based on 2D and 3D contours: application to the distal femur. Comput Methods Biomech Biomed Engin. 2003 Feb;6(1):1-6. doi: 10.1080/1025584031000065956.

Reference Type BACKGROUND
PMID: 12623432 (View on PubMed)

Mitulescu A, Skalli W, Mitton D, De Guise JA. Three-dimensional surface rendering reconstruction of scoliotic vertebrae using a non stereo-corresponding points technique. Eur Spine J. 2002 Aug;11(4):344-52. doi: 10.1007/s00586-002-0432-8. Epub 2002 Jun 26.

Reference Type BACKGROUND
PMID: 12193996 (View on PubMed)

Mitulescu A, Semaan I, De Guise JA, Leborgne P, Adamsbaum C, Skalli W. Validation of the non-stereo corresponding points stereoradiographic 3D reconstruction technique. Med Biol Eng Comput. 2001 Mar;39(2):152-8. doi: 10.1007/BF02344797.

Reference Type BACKGROUND
PMID: 11361240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9662585 (View on PubMed)

Other Identifiers

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CHUBX 2008/32

Identifier Type: -

Identifier Source: org_study_id

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