Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
NCT07594574 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2026-05-19
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.
Conditions
- Paralytic Scoliosis
- Pelvic Obliquity
- Spinal Cord Injury
- Neuromuscular Scoliosis
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
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
Sponsors & Collaborators
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-10
- Primary Completion
- 2026-08-09
- Completion
- 2026-09-01
Countries
- China
Study Locations
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