NCT00926432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

1.4 years

First QC Date

June 18, 2009

Last Update Submit

May 6, 2013

Conditions

Postural Balance

Keywords

BalanceSpine disordersequilibrium

Outcome Measures

Primary Outcomes (1)

  • To assess the three-dimensional geometrical configuration of the skeleton with respect to the gravity line on a large population of patient presenting a broad spectrum of pathologies inducing postural imbalance.

    1 day

Secondary Outcomes (5)

  • 3D Position of the middle of acoustic meati, of each vertebral body, of the center of both acetabula and the barycentre of the four condyles with respect to the gravity line.

    1 day

  • Morphologic and positioning parameters of the pelvis (pelvic incidence, pelvic version, sacral slope & pelvic radius)

    1 day

  • Kyphosis, lordosis and sinopelvic balance

    1 day

  • To validate the measure of femoral and tibial torsion using EOS™ images

    1 day

  • influence of position change on the evaluation of changes in postural balance following surgery

    After surgery

Study Arms (2)

Healthy volunteers

OTHER

Small group of aged healthy volunteers

Device: EOS™ Acquisition

Patients

OTHER

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

Device: EOS™ Acquisition

Interventions

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.

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bordeaux, 33076, France

Location

Related Publications (30)

  • 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.

    PMID: 18033112BACKGROUND

  • 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.

    PMID: 17139212BACKGROUND

  • 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.

    PMID: 16721280BACKGROUND

  • 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.

    PMID: 15990669BACKGROUND

  • 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.

    PMID: 15908871BACKGROUND

  • 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: 16114859BACKGROUND

  • 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.

    PMID: 15687145BACKGROUND

  • 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.

    PMID: 15480123BACKGROUND

  • 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.

    PMID: 15480143BACKGROUND

  • 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.

    PMID: 14722414BACKGROUND

  • 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.

    PMID: 13680185BACKGROUND

  • 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.

    PMID: 12782985BACKGROUND

  • 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.

    PMID: 11891447BACKGROUND

  • 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: 9629932BACKGROUND

  • 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.

    PMID: 9728376BACKGROUND

  • 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.

    PMID: 7676332BACKGROUND

  • 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.

    PMID: 17981286BACKGROUND

  • 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.

    PMID: 17978655BACKGROUND

  • 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.

    PMID: 17334292BACKGROUND

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

    PMID: 6880151BACKGROUND

  • 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.

    PMID: 16235661BACKGROUND

  • 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.

    PMID: 15792937BACKGROUND

  • 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.

    PMID: 15003338BACKGROUND

  • 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.

    PMID: 14752344BACKGROUND

  • 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.

    PMID: 15147749BACKGROUND

  • 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.

    PMID: 15457739BACKGROUND

  • 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.

    PMID: 12623432BACKGROUND

  • 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.

    PMID: 12193996BACKGROUND

  • 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.

    PMID: 11361240BACKGROUND

  • 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: 9662585BACKGROUND

Study Officials

  • Jean-Marc VITAL, Professor

    Hospital University, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Wafa SKALLI, PhD, Pr

    Laboratoire de Biomécanique Arts et Metiers ParisTech-CNRS UMR 8005

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 23, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

FR(1)