Posterior Minimally Invasive Surgery for Treating Paralytic Scoliosis With Pelvic Obliquity in Children Following Spinal Cord Injury
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.
研究概览
地位
主动，不招人
详细说明
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.
研究类型
介入性
注册 (实际的)
39
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Jiangsu
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Nanjing、Jiangsu、中国、210000
- Drum Tower Hospital of Nanjing University Medical School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Posterior Minimally Invasive Correction Surgery
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.
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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.
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有源比较器：Conventional Posterior Spinal Fusion
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.
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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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pelvic Obliquity Angle
大体时间：Baseline, immediately after surgery and 24 months after surgery
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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.
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Baseline, immediately after surgery and 24 months after surgery
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Coronal Cobb Angle
大体时间：Baseline, immediately after surgery and 24 months after surgery
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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.
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Baseline, immediately after surgery and 24 months after surgery
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Coronal Balance
大体时间：Baseline, immediately after surgery and 24 months after surgery
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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.
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Baseline, immediately after surgery and 24 months after surgery
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Surgical Complications
大体时间：From surgery to 24 months after surgery
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Complications including wound infection, pulmonary complications, neurological deterioration, implant malposition, implant loosening or failure, unplanned revision surgery, and other adverse events will be recorded.
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From surgery to 24 months after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operative Time
大体时间：During surgery
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Operative time will be recorded in minutes from skin incision to wound closure.
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During surgery
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Intraoperative Blood Loss
大体时间：During surgery
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Estimated intraoperative blood loss will be recorded in milliliters according to the anesthesia and operative records.
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During surgery
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Intensive Care Unit Admission
大体时间：From the end of surgery to hospital discharge, up to 30 days
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The proportion of participants requiring postoperative admission to the intensive care unit will be recorded.
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From the end of surgery to hospital discharge, up to 30 days
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Length of Hospital Stay
大体时间：From admission to discharge, up to 60 days
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Length of hospital stay will be recorded in days.
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From admission to discharge, up to 60 days
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Total Hospitalization Cost
大体时间：From admission to discharge, up to 60 days
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Total hospitalization cost will be collected from the hospital billing system and recorded in Chinese yuan.
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From admission to discharge, up to 60 days
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Baseline and 24 months after surgery
大体时间：Baseline and 24 months after surgery
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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.
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Baseline and 24 months after surgery
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Reoperation Rate
大体时间：From surgery to 24 months after surgery
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The proportion of participants requiring unplanned reoperation related to the index spinal deformity surgery will be recorded.
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From surgery to 24 months after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dalyan M, Cardenas DD, Gerard B. Upper extremity pain after spinal cord injury. Spinal Cord. 1999 Mar;37(3):191-5. doi: 10.1038/sj.sc.3100802.
- Westerlund LE, Gill SS, Jarosz TS, Abel MF, Blanco JS. Posterior-only unit rod instrumentation and fusion for neuromuscular scoliosis. Spine (Phila Pa 1976). 2001 Sep 15;26(18):1984-9. doi: 10.1097/00007632-200109150-00008.
- 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.
- 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.
- Rong T, Shen J, Wang Y, Li Z, Lin Y, Tan H, Feng E, Jiao Y. The Effect of Traditional Single Growing Rod Technique on the Growth of Unsegmented Levels in Mixed-Type Congenital Scoliosis. Global Spine J. 2022 Jun;12(5):922-930. doi: 10.1177/2192568220972080. Epub 2020 Nov 18.
- Pei B, Lu D, Wu X, Xu Y, Ma C, Wu S. Effects of Growing Rod Technique with Different Surgical Modes and Growth Phases on the Treatment Outcome of Early Onset Scoliosis: A 3-D Finite Element Analysis. Int J Environ Res Public Health. 2022 Feb 12;19(4):2057. doi: 10.3390/ijerph19042057.
- Modi HN, Suh SW, Fernandez H, Yang JH, Song HR. Accuracy and safety of pedicle screw placement in neuromuscular scoliosis with free-hand technique. Eur Spine J. 2008 Dec;17(12):1686-96. doi: 10.1007/s00586-008-0795-6. Epub 2008 Oct 1.
- Wang Y, Zhu F, Zeng L, Wang S, Liu Y, Yang L, Zhao W, Zhou Y, Wu Z, Li M, Feng Y, Shen X, Guo X. Surfer Myelopathy in Children: A Case Series Study. World Neurosurg. 2021 Apr;148:e227-e241. doi: 10.1016/j.wneu.2020.12.135. Epub 2021 Jan 5.
- Tong AN, Zhang JW, Zhou HJ, Tang HH, Bai JZ, Wang FY, Lv Z, Chen SZ, Liu SJ, Liu JS, Hong Y. Ischemic damage may play an important role in spinal cord injury during dancing. Spinal Cord. 2020 Dec;58(12):1310-1316. doi: 10.1038/s41393-020-0503-x. Epub 2020 Jun 19.
- Holt JB, Dolan LA, Weinstein SL. Outcomes of Primary Posterior Spinal Fusion for Scoliosis in Spinal Muscular Atrophy: Clinical, Radiographic, and Pulmonary Outcomes and Complications. J Pediatr Orthop. 2017 Dec;37(8):e505-e511. doi: 10.1097/BPO.0000000000001049.
- Hwang SW, Safain MG, King JJ, Kimball JS, Ames R, Betz RR, Cahill PJ, Samdani AF. Management of spinal cord injury-related scoliosis using pedicle screw-only constructs. J Neurosurg Spine. 2015 Feb;22(2):185-91. doi: 10.3171/2014.10.SPINE14185. Epub 2014 Nov 21.
- Wolff S, Moreau PE, Miladi L, Riouallon G. Is Minimally Invasive Bipolar Technique a Better Alternative to Long Fusion for Adult Neuromuscular Scoliosis? Global Spine J. 2024 Sep;14(7):1909-1919. doi: 10.1177/21925682231159347. Epub 2023 Feb 21.
- Ray WZ, Ravindra VM, Schmidt MH, Dailey AT. Stereotactic navigation with the O-arm for placement of S-2 alar iliac screws in pelvic lumbar fixation. J Neurosurg Spine. 2013 May;18(5):490-5. doi: 10.3171/2013.2.SPINE12813. Epub 2013 Mar 15.
- Gaume M, Vergari C, Khouri N, Skalli W, Glorion C, Miladi L. Minimally Invasive Surgery for Neuromuscular Scoliosis: Results and Complications at a Minimal Follow-up of 5 Years. Spine (Phila Pa 1976). 2021 Dec 15;46(24):1696-1704. doi: 10.1097/BRS.0000000000004082.
- Minimally invasive scoliosis surgery assisted by O-arm navigation for Lenke Type 5C adolescent idiopathic scoliosis: a comparison with standard open approach spinal instrumentation. J Neurosurg Pediatr. 2017 Apr;19(4):472-478. doi: 10.3171/2016.11.PEDS16412. Epub 2017 Feb 10.
- de Bodman C, Miyanji F, Borner B, Zambelli PY, Racloz G, Dayer R. Minimally invasive surgery for adolescent idiopathic scoliosis: correction of deformity and peri-operative morbidity in 70 consecutive patients. Bone Joint J. 2017 Dec;99-B(12):1651-1657. doi: 10.1302/0301-620X.99B12.BJJ-2017-0022.R2.
- Sun X, Xu L, Chen Z, Shi B, Chen X, Li S, Du C, Zhou Q, Qiu Y, Zhu Z. Hybrid Growing Rod Technique of Osteotomy With Short Fusion and Spinal Distraction: An Alternative Solution for Long-Spanned Congenital Scoliosis. Spine (Phila Pa 1976). 2019 May 15;44(10):707-714. doi: 10.1097/BRS.0000000000002933.
- Schottler J, Vogel LC, Sturm P. Spinal cord injuries in young children: a review of children injured at 5 years of age and younger. Dev Med Child Neurol. 2012 Dec;54(12):1138-43. doi: 10.1111/j.1469-8749.2012.04411.x. Epub 2012 Sep 23.
- Hodgkinson I, Berard C, Chotel F, Berard J. [Pelvic obliquity and scoliosis in non-ambulatory patients with cerebral palsy: a descriptive study of 234 patients over 15 years of age]. Rev Chir Orthop Reparatrice Appar Mot. 2002 Jun;88(4):337-41. French.
- Tang Z, Hu Z, Zhu Z, Qiao J, Mao S, Ling C, Qiu Y, Liu Z. The Utilization of Dual Second Sacral Alar-Iliac Screws for Spinopelvic Fixation in Patients with Severe Kyphoscoliosis. Orthop Surg. 2022 Jul;14(7):1457-1468. doi: 10.1111/os.13348. Epub 2022 Jun 13.
- Miladi L, Gaume M, Khouri N, Johnson M, Topouchian V, Glorion C. Minimally Invasive Surgery for Neuromuscular Scoliosis: Results and Complications in a Series of One Hundred Patients. Spine (Phila Pa 1976). 2018 Aug;43(16):E968-E975. doi: 10.1097/BRS.0000000000002588.
- Honeyman C, Davison J. Patients' experience of adolescent idiopathic scoliosis surgery: a phenomenological analysis. Nurs Child Young People. 2016 Sep 12;28(7):29-36. doi: 10.7748/ncyp.2016.e726.
- Tsirikos AI, Markham P, McMaster MJ. Surgical correction of spinal deformities following spinal cord injury occurring in childhood. J Surg Orthop Adv. 2007 Winter;16(4):174-86.
- Gohritz A, Friden J. Management of Spinal Cord Injury-Induced Upper Extremity Spasticity. Hand Clin. 2018 Nov;34(4):555-565. doi: 10.1016/j.hcl.2018.07.001. Epub 2018 Aug 20.
- Canosa-Hermida E, Mora-Boga R, Cabrera-Sarmiento JJ, Ferreiro-Velasco ME, Salvador-de la Barrera S, Rodriguez-Sotillo A, Montoto-Marques A. Epidemiology of traumatic spinal cord injury in childhood and adolescence in Galicia, Spain: report of the last 26-years. J Spinal Cord Med. 2019 Jul;42(4):423-429. doi: 10.1080/10790268.2017.1389836. Epub 2017 Oct 23.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年8月10日
初级完成 (估计的)
2026年8月9日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年5月19日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2024-JS-97
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
IPD 共享时间框架
Beginning 6 months after publication of the main trial results and ending 5 years after publication.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.