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

Not Applicable

Completed

• Conditions: Neuromuscular Scoliosis
• Interventions: Other: Ultrasound elastography (USE)

• Registration Number: NCT04969770
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Study Start: 2022-01-11
• Primary Completion: 2024-07-28
• Study Completion: 2024-07-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Ultrasound elastography (USE)	Minor patients without neuromuscular pathology or scoliosis and followed at Necker Hospital
Neuromuscular pathologies without instrumented scoliosis	Ultrasound elastography (USE)	Minor patients with neuromuscular pathology without instrumented scoliosis and followed at Necker Hospital
Neuromuscular scoliosis	Ultrasound elastography (USE)	Minor patients with neuromuscular scoliosis and followed at Necker Hospital

Primary Outcome Measures

Name	Time	Method
Discal stiffness	2 years	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	2 years	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

Name	Time	Method
Biomechanical characteristics of the construct	2 years	Influence of spinal stiffness on biomechanical characteristics of the construct : distance between the rods and the spine, causing an osteo-inductive process
Parameters influencing the progressive stiffening of the spine	2 years	Research and description of clinical parameters influencing the progressive stiffening of the spine, e.g. , age, etiology, spinal deformity and correction, BMI
Occurrence of rod fracture	2 years	Occurrence or not of a rod fracture on X-rays

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France