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NCT Number: NCT07594574

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior Minimally Invasive Correction Surgery

Procedure

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.

Conventional Posterior Spinal Fusion

Procedure

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

Primary outcomes

  1. Pelvic Obliquity Angle

    Time frame: 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.

  2. Coronal Cobb Angle

    Time frame: 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.

  3. Coronal Balance

    Time frame: 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.

  4. Surgical Complications

    Time frame: 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.

Secondary outcomes

  1. Operative Time

    Time frame: During surgery

    Operative time will be recorded in minutes from skin incision to wound closure.

  2. Intraoperative Blood Loss

    Time frame: During surgery

    Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records.

  3. Intensive Care Unit Admission

    Time frame: 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.

  4. Length of Hospital Stay

    Time frame: From admission to discharge, up to 60 days

    Length of hospital stay will be recorded in days.

  5. Total Hospitalization Cost

    Time frame: From admission to discharge, up to 60 days

    Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan.

  6. Baseline and 24 months after surgery

    Time frame: 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.

  7. Reoperation Rate

    Time frame: From surgery to 24 months after surgery

    The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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