Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct (ELASTO)
Primary Purpose
Neuromuscular Scoliosis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound elastography (USE)
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Scoliosis focused on measuring Neuromuscular scoliosis, Innovative fusionless surgery, Bipolar spine construct, Minimally invasive approach, Ultrasound elastography (USE)
Eligibility Criteria
Inclusion Criteria:
- Minor patients between 10 and <18 years old, presenting a neuromuscular pathology, with progressive scoliosis, to undergo for their clinical care a fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach
- Minor patients between 10 and <18 years old, presenting a neuromuscular pathology such as encephalopathy / infantile spinal amyotrophy / myopathy, without progressive scoliosis
- Minor patients between 10 and <18 years old, healthy controls, followed in orthopedics for a pathology other than neuromuscular or spinal deformity
- Written informed consent
Exclusion Criteria:
- No social insurance
- Severe mental retardation or severe dystonia making data acquisition impossible or requiring sedation
- Patients with gastrostomy or tracheostomy
Sites / Locations
- Hôpital Necker-Enfants Malades
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Neuromuscular scoliosis
Neuromuscular pathologies without instrumented scoliosis
Controls
Arm Description
Minor patients with neuromuscular scoliosis and followed at Necker Hospital
Minor patients with neuromuscular pathology without instrumented scoliosis and followed at Necker Hospital
Minor patients without neuromuscular pathology or scoliosis and followed at Necker Hospital
Outcomes
Primary Outcome Measures
Discal stiffness
Ultrasound elastography (USE) Measurements performed in the transverse plane of L3-L4 intervertebral disc. A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e., 30 images) is recorded. The average of these measurements is reported.
Paravertebral muscular stiffness
Ultrasound elastography (USE) Measurement performed in the longitudinal plane, in the axis of muscular fibers and in the middle of multifidus muscle.
A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e. 30 images) is recorded. The average of these measurements is reported in rest and passive stretching position, on the right side and on the left side.
Secondary Outcome Measures
Parameters influencing the progressive stiffening of the spine
Research and description of clinical parameters influencing the progressive stiffening of the spine, e.g. , age, etiology, spinal deformity and correction, BMI
Biomechanical characteristics of the construct
Influence of spinal stiffness on biomechanical characteristics of the construct : distance between the rods and the spine, causing an osteo-inductive process
Occurrence of rod fracture
Occurrence or not of a rod fracture on X-rays
Full Information
NCT ID
NCT04969770
First Posted
June 25, 2021
Last Updated
August 29, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04969770
Brief Title
Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct
Acronym
ELASTO
Official Title
Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neuromuscular scoliosis are caused by a disorder of the brain, spinal cord or muscular system and often progressive at early age. Conservative treatment is not sufficient to maintain trunk and pelvic balance, and surgical treatment is frequently required. Early definitive spine fusion has the disadvantage of cessation of trunk growth with concomitant effects on lung development. Growth preserving spine surgeries are increasingly used but with high complication rates.
The orthopaedic team at Necker Hospital Enfants maladies, Paris, France has developed an innovative fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach. The first 100 patients operated on with this technique had an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence, was necessary thanks to the stability of the correction of the deformities even after skeletal maturation.
The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.
Detailed Description
Neuromuscular scoliosis is related to muscle tone abnormalities with a prognosis worsen by damage to the axial and respiratory muscles.
The classic treatment for these scoliosis consists of conservative treatment (physiotherapy, bracing), followed by arthrodesis in adolescence. Arthrodesis consists of a global posterior spinal fusion, with a high risk of septic and hemorrhagic complications.
In cases of early and rapidly progressive deformities, fusionless techniques allow the preservation of growth while waiting for arthrodesis. However, these techniques have a high rate of complications, particularly of mechanical and infectious origin, which led the orthopedic team at Necker Hospital, Paris, France to develop an innovative technique. This technique is based on bipolar construct, performed by a minimally invasive approach. The first 100 patients operated on have an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence for these patients, was necessary, thanks to the stability of the correction even after skeletal maturation.
The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Scoliosis
Keywords
Neuromuscular scoliosis, Innovative fusionless surgery, Bipolar spine construct, Minimally invasive approach, Ultrasound elastography (USE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular scoliosis
Arm Type
Experimental
Arm Description
Minor patients with neuromuscular scoliosis and followed at Necker Hospital
Arm Title
Neuromuscular pathologies without instrumented scoliosis
Arm Type
Other
Arm Description
Minor patients with neuromuscular pathology without instrumented scoliosis and followed at Necker Hospital
Arm Title
Controls
Arm Type
Other
Arm Description
Minor patients without neuromuscular pathology or scoliosis and followed at Necker Hospital
Intervention Type
Other
Intervention Name(s)
Ultrasound elastography (USE)
Intervention Description
Visualization of the vertebral disc and the para-vertebral muscles.
Intra and inter observer reproducibility analysis carried out for each of the measurements made, by two operators.
Patients with instrumented neuromuscular scoliosis: 5 elastographies : preoperatively, then during the usual follow-up consultations with the surgeon every 6 months for 2 years.
Patients with neuromuscular pathologies without instrumented scoliosis: 4 elastographies during the usual follow-up consultations with the surgeon every 6 months for 2 years.
Healthy control patients without neuromuscular pathology or scoliosis :
1 elastography during an usual consultation.
Primary Outcome Measure Information:
Title
Discal stiffness
Description
Ultrasound elastography (USE) Measurements performed in the transverse plane of L3-L4 intervertebral disc. A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e., 30 images) is recorded. The average of these measurements is reported.
Time Frame
2 years
Title
Paravertebral muscular stiffness
Description
Ultrasound elastography (USE) Measurement performed in the longitudinal plane, in the axis of muscular fibers and in the middle of multifidus muscle.
A rectangular strip is selected and a series of 3 clips of 10 seconds (i.e. 30 images) is recorded. The average of these measurements is reported in rest and passive stretching position, on the right side and on the left side.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Parameters influencing the progressive stiffening of the spine
Description
Research and description of clinical parameters influencing the progressive stiffening of the spine, e.g. , age, etiology, spinal deformity and correction, BMI
Time Frame
2 years
Title
Biomechanical characteristics of the construct
Description
Influence of spinal stiffness on biomechanical characteristics of the construct : distance between the rods and the spine, causing an osteo-inductive process
Time Frame
2 years
Title
Occurrence of rod fracture
Description
Occurrence or not of a rod fracture on X-rays
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minor patients between 10 and <18 years old, presenting a neuromuscular pathology, with progressive scoliosis, to undergo for their clinical care a fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach
Minor patients between 10 and <18 years old, presenting a neuromuscular pathology such as encephalopathy / infantile spinal amyotrophy / myopathy, without progressive scoliosis
Minor patients between 10 and <18 years old, healthy controls, followed in orthopedics for a pathology other than neuromuscular or spinal deformity
Written informed consent
Exclusion Criteria:
No social insurance
Severe mental retardation or severe dystonia making data acquisition impossible or requiring sedation
Patients with gastrostomy or tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde Gaume, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lofti Miladi, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct
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