Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

NCT04969770 | Completed

• 2 other identifiers: APHP210752ID-RCB 2020-A03598-31
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Scoliosis

Keywords

Neuromuscular scoliosis; Innovative fusionless surgery; Bipolar spine construct; Minimally invasive approach; Ultrasound elastography (USE)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Parameters influencing the progressive stiffening of the spine

  2 years

• Biomechanical characteristics of the construct

  2 years

• Occurrence of rod fracture

  2 years

Study Arms (3)

Neuromuscular scoliosis

EXPERIMENTAL

Minor patients with neuromuscular scoliosis and followed at Necker Hospital

Other: Ultrasound elastography (USE)

Neuromuscular pathologies without instrumented scoliosis

OTHER

Minor patients with neuromuscular pathology without instrumented scoliosis and followed at Necker Hospital

Other: Ultrasound elastography (USE)

Controls

OTHER

Minor patients without neuromuscular pathology or scoliosis and followed at Necker Hospital

Other: Ultrasound elastography (USE)

Interventions

Ultrasound elastography (USE) OTHER

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.

Controls; Neuromuscular pathologies without instrumented scoliosis; Neuromuscular scoliosis

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• No social insurance
• Severe mental retardation or severe dystonia making data acquisition impossible or requiring sedation
• Patients with gastrostomy or tracheostomy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• Gaume M, Loiselet K, Chekir H, Langlais T, Boddaert N, Stricker S, Pannier S, Skalli W, Miladi L, Vergari C. Evidence of spinal stiffening following fusionless bipolar fixation for neuromuscular scoliosis: a shear wave elastography assessment of lumbar annulus fibrosus. Eur Spine J. 2024 Apr;33(4):1617-1623. doi: 10.1007/s00586-023-08013-8. Epub 2023 Nov 4.

  PMID: 37924389 BACKGROUND

Study Officials

• Mathilde Gaume, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Lofti Miladi, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 21, 2021
• Study Start: January 11, 2022
• Primary Completion: July 28, 2024
• Study Completion: July 28, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)