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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pelvic Obliquity Angle — 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.
• Coronal Cobb Angle — 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.
• Coronal Balance — 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.
• Surgical Complications — 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.

Trial sites (1)

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

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