Normative Dynamic & Magnetic Spine

Healthy Volunteers Clinical Trial

— NDMS  

Official title:

Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03125434
• Other study ID #: 2016-A01825-46
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dynamic Stability Margin
• Gait
• Healthy Volunteers
• Paraspinal Muscles

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