Neuromuscular Scoliosis Clinical Trial
— ELASTOOfficial title:
Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct
Verified date | March 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker-Enfants Malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Primary | 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. |
2 years | |
Secondary | 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 | 2 years | |
Secondary | 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 | 2 years | |
Secondary | Occurrence of rod fracture | Occurrence or not of a rod fracture on X-rays | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06023043 -
Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients
|
Phase 4 | |
Completed |
NCT04021784 -
Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis
|
N/A | |
Recruiting |
NCT04764812 -
Determination of Risk Factors and Awareness Associated With Development of Neuromuscular Scoliosis
|
||
Completed |
NCT01645111 -
An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06367933 -
Mini-invasive Spine Surgery for Neuromuscolar Scoliosis
|
N/A | |
Completed |
NCT03000010 -
Wound Vac Bandage Comparison After Spinal Fusion
|
N/A | |
Completed |
NCT03863496 -
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
|
N/A | |
Recruiting |
NCT06042699 -
Scoliosis Iron Supplementation Study
|
N/A | |
Recruiting |
NCT05281757 -
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
|
||
Recruiting |
NCT05071144 -
Spine Procedures Assisted With RoboTics And Navigation
|
||
Completed |
NCT04012112 -
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
|
N/A | |
Terminated |
NCT02670798 -
Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery
|
N/A | |
Completed |
NCT03862625 -
Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
|
N/A |