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

NCT07594574 | Active Not Recruiting DMC

• 1 other identifier: 2024-JS-97
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Posterior minimally invasive surgery; Posterior spinal fusion; Second sacral alar-iliac screw; S2AI screw; Pediatric spinal deformity; Spinal cord injury

Outcome Measures

Primary Outcomes (4)

• Pelvic Obliquity Angle

  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

  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

  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

  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

Secondary Outcomes (7)

• Operative Time

  During surgery

• Intraoperative Blood Loss

  During surgery

• Intensive Care Unit Admission

  From the end of surgery to hospital discharge, up to 30 days

• Length of Hospital Stay

  From admission to discharge, up to 60 days

• Total Hospitalization Cost

  From admission to discharge, up to 60 days

Study Arms (2)

Posterior Minimally Invasive Correction Surgery

EXPERIMENTAL

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.

Procedure: Posterior Minimally Invasive Correction Surgery

Conventional Posterior Spinal Fusion

ACTIVE COMPARATOR

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.

Procedure: Conventional Posterior Spinal Fusion

Interventions

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.

Posterior Minimally Invasive Correction Surgery

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

Conventional Posterior Spinal Fusion

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

Related Publications (25)

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the surgical interventions, participants, surgeons, and clinical care providers cannot be blinded. Radiographic measurements will be performed using standardized methods by assessors not involved in the index surgery whenever feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to either posterior minimally invasive correction surgery or conventional posterior spinal fusion.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: August 10, 2024
• Primary Completion (Estimated): August 9, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the main trial results and ending 5 years after publication.
• Access Criteria: 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.

Locations

CN (1)