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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Operative time will be recorded in minutes from skin incision to wound closure. | During surgery |
| Intraoperative Blood Loss | Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35454335 | Background | Ishihara M, Taniguchi S, Kawashima K, Adachi T, Paku M, Tani Y, Ando M, Saito T. Bone Fusion Morphology after Circumferential Minimally Invasive Spine Surgery Using Lateral Lumbar Interbody Fusion and Percutaneous Pedicle Screws without Bone Grafting in the Thoracic Spine: A Retrospective Study. Medicina (Kaunas). 2022 Mar 30;58(4):496. doi: 10.3390/medicina58040496. | |
| 20683383 |
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De-identified individual participant data underlying the results reported in the final publication may be shared upon reasonable request after publication. Shared data may include baseline characteristics, radiographic measurements, perioperative outcomes, complications, and patient-reported outcome scores. Data will be de-identified to protect participant privacy, particularly because the study involves pediatric participants with a rare condition.
Beginning 6 months after publication of the main trial results and ending 5 years after publication.
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.
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Participants will be randomized in a 1:1 ratio to either posterior minimally invasive correction surgery or conventional posterior spinal fusion.
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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.
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| 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 |
|
| During surgery |
| Intensive Care Unit Admission | The proportion of participants requiring postoperative admission to the intensive care unit will be recorded. | From the end of surgery to hospital discharge, up to 30 days |
| Length of Hospital Stay | Length of hospital stay will be recorded in days. | From admission to discharge, up to 60 days |
| Total Hospitalization Cost | Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan. | From admission to discharge, up to 60 days |
| 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. | Baseline and 24 months after surgery |
| Reoperation Rate | The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded. | From surgery to 24 months after surgery |
| Background |
| Cahill PJ, Marvil S, Cuddihy L, Schutt C, Idema J, Clements DH, Antonacci MD, Asghar J, Samdani AF, Betz RR. Autofusion in the immature spine treated with growing rods. Spine (Phila Pa 1976). 2010 Oct 15;35(22):E1199-203. doi: 10.1097/BRS.0b013e3181e21b50. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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