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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03125434
Other study ID # 2016-A01825-46
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 27, 2017
Est. completion date October 23, 2020

Study information

Verified date January 2021
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and young adults by using static and dynamic measures. Static informations are obtained from full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI for muscular data. Dynamics stability is calculated from 3D gait analysis.


Description:

Spinal diseases and deformities in adults (degenerative or traumatic) and children (scoliosis and kyphosis) are major public health issues. Postural imbalance due to spinal deformity is usually measured on static radiographs, using standard X-rays. However, bipedal walk is characteristic from human being and the trunk is the main stabilizer. Pathogenesis of spinal deformities remains undefined. To understand the different mechanisms involved in the pathological field, normal musculoskeletal performances of the spine, in static and dynamic conditions must be identified. Ultra-low doses stereoradiography using the EOS system allows the acquisition of full-spine images in standing position. Furthermore, 3D reconstruction can also be create from both anteroom-posterior and lateral side view. Stereoradiography is used in clinical routine especially in children spinal deformities. High resolution muscular MRI is the only device that can provide a detailed muscular analysis, with detection of abnormalities at an early stage. No mapping of normal paraspinal muscles has been yet realized, particularly regarding to rotatores muscles. Motion analysis is the reference exam to analyse dynamic stability during gait. Several parameters reflecting stability during gait can be collected in different conditions. Recently, the "Dynamic Stability Margin" has been developed but no standard values especially in healthy children has been published.


Recruitment information / eligibility

Status Terminated
Enrollment 48
Est. completion date October 23, 2020
Est. primary completion date October 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 40 Years
Eligibility Inclusion Criteria: - Informed consent signed by adult or by the holders of parental authority for the children and adolescents - Child or teenager, male or female, aged from 8 years to 17 years inclusive - Adult, male or female, aged from 18 years to 40 years inclusive - Realization of a preliminary medical examination Exclusion Criteria: - Refuse to participate to the study - Patient under guardianship or curatorship - Inability to cooperate - Pregnant woman - Non affiliation to social security - Subject with spinal and/or lower limbs affection - Subject with antecedent of spinal and/or lower limbs surgery - Subject with contraindication to MRI - Refusal of the parent or the subject to be informed about a fortuitous discovery during the examinations of the exams

Study Design


Intervention

Other:
EOS full-spine, MRI, gait analysis
full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed

Locations

Country Name City State
France APHP Hopital raymond Poincaré Garches Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Normal dynamic stability margin (DSM) in children and adults DSM= xCoM (extrapolated center of mass)- BoS (Base of Support). Unit = meters Normalized on body height (m) 2 hours
Secondary number of rotatores muscles counting every rotatore muscle (from MRI data), no unit 2 hours
Secondary volume of back muscles from segmentation of each muscle group, unit = voxel 2 hours
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