Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.