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

NCT ID: NCT04969770

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2024-07-28

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.

Conditions

Neuromuscular Scoliosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromuscular scoliosis

Minor patients with neuromuscular scoliosis and followed at Necker Hospital

Group Type: EXPERIMENTAL

Ultrasound elastography (USE)

Intervention Type: 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.

Neuromuscular pathologies without instrumented scoliosis

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

Group Type: OTHER

Ultrasound elastography (USE)

Intervention Type: 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

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

Group Type: OTHER

Ultrasound elastography (USE)

Intervention Type: 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.

Interventions

Ultrasound elastography (USE)

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathilde Gaume, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Lofti Miladi, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37924389 (View on PubMed)

Other Identifiers

ID-RCB 2020-A03598-31

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210752

Identifier Type: -

Identifier Source: org_study_id