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

Nanjing University

Status: Active, not recruiting

Conditions: Neuromuscular Scoliosis; Pelvic Obliquity; Paralytic Scoliosis; Spinal Cord Injury

Treatments: Procedure: Conventional Posterior Spinal Fusion; Procedure: Posterior Minimally Invasive Correction Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07594574

2024-JS-97

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Posterior Minimally Invasive Correction Surgery

Experimental group

Description:

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.

Treatment:

Procedure: Posterior Minimally Invasive Correction Surgery

Conventional Posterior Spinal Fusion

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Posterior Spinal Fusion