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

11 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

39

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Procedura: 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.
Aktywny komparator: 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.
Procedura: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pelvic Obliquity Angle
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Operative Time
Ramy czasowe: During surgery
Operative time will be recorded in minutes from skin incision to wound closure.
During surgery
Intraoperative Blood Loss
Ramy czasowe: During surgery
Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records.
During surgery
Intensive Care Unit Admission
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 sierpnia 2024

Zakończenie podstawowe (Szacowany)

9 sierpnia 2026

Ukończenie studiów (Szacowany)

1 września 2026

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024-JS-97

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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