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Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury

11 mai 2026 mis à jour par: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
This randomized controlled trial compares posterior minimally invasive correction surgery with conventional posterior spinal fusion for children with paralytic scoliosis and severe pelvic obliquity following spinal cord injury. Conventional posterior spinal fusion is widely used for severe neuromuscular or paralytic scoliosis but is associated with substantial surgical trauma, blood loss, transfusion requirements, and perioperative morbidity. The minimally invasive approach uses limited posterior incisions, posterior instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The study will evaluate whether minimally invasive surgery provides comparable correction of pelvic obliquity and spinal deformity while reducing perioperative surgical burden, complications, hospital stay, and medical costs.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Paralytic scoliosis following spinal cord injury in childhood is a specific subtype of neuromuscular scoliosis. Patients are often nonambulatory and may develop progressive long C-shaped thoracolumbar or lumbar curves, severe pelvic obliquity, impaired sitting balance, pain, hip dysplasia or subluxation, and functional limitation of the upper limbs due to the need for hand support while sitting. Surgical treatment aims to restore sitting balance, level the pelvis, improve trunk alignment, reduce pain caused by imbalance, and preserve or improve functional independence.

Conventional posterior spinal fusion can correct spinal deformity and pelvic obliquity but usually requires extensive posterior exposure and long-segment fusion, which may increase operative time, blood loss, transfusion volume, wound complications, intensive care unit admission, and hospitalization costs. A posterior minimally invasive correction technique using limited incisions and spinopelvic fixation may reduce surgical trauma while maintaining adequate deformity correction.

This is a prospective, single-center, randomized, parallel-group controlled trial. Eligible participants will be randomized in a 1:1 ratio to receive either posterior minimally invasive correction surgery or conventional posterior spinal fusion. Radiographic outcomes, including pelvic obliquity angle, coronal Cobb angle, regional kyphosis, and coronal balance, will be assessed preoperatively, postoperatively, and during follow-up. Perioperative outcomes, complications, reoperations, health-related quality of life, and medical costs will also be recorded.

The study protocol was approved by the institutional ethics committee before participant enrollment. The trial was registered after enrollment had begun because of an administrative oversight. No interim efficacy analysis was performed before trial registration.

Type d'étude

Interventionnel

Inscription (Réel)

39

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210000
        • Drum Tower Hospital of Nanjing University Medical School

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 6 to 20 years at the time of enrollment.
  • Diagnosis of paralytic scoliosis secondary to spinal cord injury during childhood.
  • Severe pelvic obliquity, defined as pelvic obliquity angle greater than 15 degrees on sitting full-spine anteroposterior radiographs.
  • Major coronal scoliosis curve with Cobb angle greater than 40 degrees, or progressive deformity considered to require surgical correction by the treating spine deformity team.
  • Nonambulatory status or severe lower-limb motor dysfunction after spinal cord injury.
  • Planned surgical correction requiring spinopelvic fixation.
  • Ability to undergo sitting full-spine radiographic assessment before surgery and during follow-up.
  • Written informed consent provided by the parent or legal guardian, with participant assent when applicable.

Exclusion Criteria:

  • Idiopathic scoliosis, congenital scoliosis, syndromic scoliosis, or spinal deformity caused by etiologies other than spinal cord injury.
  • Neuromuscular scoliosis caused by cerebral palsy, spinal muscular atrophy, muscular dystrophy, myelomeningocele, poliomyelitis, or other primary neuromuscular diseases.
  • Previous spinal deformity correction surgery or previous long-segment spinal fusion.
  • Active systemic infection or uncontrolled local infection at the planned surgical site.
  • Severe pressure ulcer, osteomyelitis, or soft tissue condition that precludes safe posterior spinal surgery.
  • Severe cardiopulmonary, hematologic, hepatic, renal, or other systemic disease that makes the participant unsuitable for major spinal surgery.
  • Coagulation disorder or other condition associated with unacceptable bleeding risk.
  • Inability to complete the planned follow-up schedule.
  • Participation in another interventional trial that may affect the outcomes of this study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Posterior Minimally Invasive Correction Surgery
Participants randomized to this arm will undergo posterior minimally invasive correction surgery using limited posterior incisions, posterior spinal instrumentation, and spinopelvic fixation with second sacral alar-iliac screws. The technique aims to correct scoliosis and pelvic obliquity while reducing soft tissue dissection and perioperative surgical trauma.
Procédure: Posterior Minimally Invasive Correction Surgery
The posterior minimally invasive correction procedure is performed under general anesthesia with intraoperative neuromonitoring. Limited posterior incisions are made at the proximal thoracic region and the distal lumbosacral region. Proximal pedicle screw fixation and distal lumbosacral and pelvic fixation with second sacral alar-iliac screws are performed according to the planned construct. Precontoured rods are inserted through the incisions and passed subcutaneously or through a minimally invasive soft tissue tunnel, with connectors used as required. Deformity correction is performed to improve spinal alignment and pelvic obliquity. Limited fusion or bone grafting is performed at planned fixation areas according to the surgical protocol.
Comparateur actif: Conventional Posterior Spinal Fusion
Participants randomized to this arm will undergo conventional open posterior spinal fusion with long-segment posterior exposure, posterior spinal instrumentation, deformity correction, bone grafting, and spinopelvic fixation with second sacral alar-iliac screws according to standard surgical practice.
Procédure: Conventional Posterior Spinal Fusion
The conventional posterior spinal fusion procedure is performed under general anesthesia with intraoperative neuromonitoring. A standard long posterior midline incision is used to expose the planned instrumented segments. Pedicle screws and second sacral alar-iliac screws are inserted according to the surgical plan. Posterior release, deformity correction, rod placement, and bone grafting are performed according to standard open posterior spinal fusion techniques

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pelvic Obliquity Angle
Délai: Baseline, immediately after surgery and 24 months after surgery
Pelvic obliquity angle will be measured on sitting full-spine anteroposterior radiographs. The angle is defined as the angle between the line connecting the bilateral anterior superior iliac spines and the horizontal reference line. The primary outcome is the change in pelvic obliquity angle from baseline to 24 months after surgery.
Baseline, immediately after surgery and 24 months after surgery
Coronal Cobb Angle
Délai: Baseline, immediately after surgery and 24 months after surgery
The major coronal curve Cobb angle will be measured on sitting full-spine anteroposterior radiographs. The outcome is the change in Cobb angle from baseline to 24 months after surgery.
Baseline, immediately after surgery and 24 months after surgery
Coronal Balance
Délai: Baseline, immediately after surgery and 24 months after surgery
Coronal balance will be assessed as the horizontal distance between the C7 plumb line and the center sacral vertical line on sitting full-spine anteroposterior radiographs.
Baseline, immediately after surgery and 24 months after surgery
Surgical Complications
Délai: From surgery to 24 months after surgery
Complications including wound infection, pulmonary complications, neurological deterioration, implant malposition, implant loosening or failure, unplanned revision surgery, and other adverse events will be recorded.
From surgery to 24 months after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Operative Time
Délai: During surgery
Operative time will be recorded in minutes from skin incision to wound closure.
During surgery
Intraoperative Blood Loss
Délai: During surgery
Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records.
During surgery
Intensive Care Unit Admission
Délai: From the end of surgery to hospital discharge, up to 30 days
The proportion of participants requiring postoperative admission to the intensive care unit will be recorded.
From the end of surgery to hospital discharge, up to 30 days
Length of Hospital Stay
Délai: From admission to discharge, up to 60 days
Length of hospital stay will be recorded in days.
From admission to discharge, up to 60 days
Total Hospitalization Cost
Délai: From admission to discharge, up to 60 days
Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan.
From admission to discharge, up to 60 days
Baseline and 24 months after surgery
Délai: Baseline and 24 months after surgery
Health-related quality of life will be assessed using the Chinese version of the Scoliosis Research Society-22 questionnaire. Domain scores and total score will be analyzed.
Baseline and 24 months after surgery
Reoperation Rate
Délai: From surgery to 24 months after surgery
The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded.
From surgery to 24 months after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 août 2024

Achèvement primaire (Estimé)

9 août 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

11 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

19 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024-JS-97

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the results reported in the final publication may be shared upon reasonable request after publication. Shared data may include baseline characteristics, radiographic measurements, perioperative outcomes, complications, and patient-reported outcome scores. Data will be de-identified to protect participant privacy, particularly because the study involves pediatric participants with a rare condition.

Délai de partage IPD

Beginning 6 months after publication of the main trial results and ending 5 years after publication.

Critères d'accès au partage IPD

Data may be shared with qualified researchers who submit a methodologically sound proposal, obtain approval from an independent ethics committee when required, and sign a data use agreement. Data will be used only for approved scientific purposes and may not be used to identify individual participants.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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