Normative Dynamic & Magnetic Spine (NDMS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers; Gait; Paraspinal Muscles; Dynamic Stability Margin
• Intervention / Treatment: Other: EOS full-spine, MRI, gait analysis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Garches, Ile De France, France, 92380
      • APHP Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy volunteers; EOS full-spine, MRI, gait analysis	Other: EOS full-spine, MRI, gait analysis; full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of rotatores muscles	counting every rotatore muscle (from MRI data), no unit	2 hours
volume of back muscles	from segmentation of each muscle group, unit = voxel	2 hours

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2017
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A01825-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No