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.
調査の概要
状態
積極的、募集していない
詳細な説明
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.
研究の種類
介入
入学 (実際)
39
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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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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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pelvic Obliquity Angle
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Operative Time
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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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- 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.
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- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年8月10日
一次修了 (推定)
2026年8月9日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2024-JS-97
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 6 months after publication of the main trial results and ending 5 years after publication.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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