Neuromuscular Scoliosis, Paralytic Scoliosis, Pelvic Obliquity, Spinal Cord Injury
Conditions
Keywords
Posterior minimally invasive surgery, Posterior spinal fusion, Second sacral alar-iliac screw, S2AI screw, Pediatric spinal deformity, Spinal cord injury
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.
Detailed description
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.
Interventions
PROCEDUREPosterior 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.
PROCEDUREConventional 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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants will be randomized in a 1:1 ratio to either posterior minimally invasive correction surgery or conventional posterior spinal fusion.
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | During surgery | Operative time will be recorded in minutes from skin incision to wound closure. |
| Intraoperative Blood Loss | During surgery | Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records. |
| Intensive Care Unit Admission | 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. |
| Length of Hospital Stay | From admission to discharge, up to 60 days | Length of hospital stay will be recorded in days. |
| Total Hospitalization Cost | From admission to discharge, up to 60 days | Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan. |
| Baseline and 24 months after surgery | 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. |
| Reoperation Rate | From surgery to 24 months after surgery | The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded. |
Countries
China
Outcome results
None listed