Spine Reference Parameters on EOS Imaging (EOS-SPINE)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 28, 2011 | ||||||||
| Last Updated Date | May 17, 2013 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01406743 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Spine Reference Parameters on EOS Imaging | ||||||||
| Official Title ICMJE | PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™ | ||||||||
| 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. |
||||||||
| 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. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | subject without spine pathology |
||||||||
| Condition ICMJE | Healthy Volunteers | ||||||||
| Intervention ICMJE | 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. |
||||||||
| Study Group/Cohort (s) | EOS™ Acquisition
Intervention: Device: EOS™ Acquisition |
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 204 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01406743 | ||||||||
| Other Study ID Numbers ICMJE | CHUBX 2010/26 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | May 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||