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The Outcome of Injured Cervical Spinal Cord With Uncontrolled Swelling Under Duraplasty

2026年9月22日 更新者:Chang Gung Memorial Hospital

Overall Objective: To assess whether incorporating duraplasty alongside bony decompression enhances motor function outcomes in individuals following Traumatic Spinal Cord Injury (TSCI).

Rationale for Research:

In a systematic review, individuals suffering from cervical Traumatic Spinal Cord Injuries (TSCIs) identified specific priorities for improvement in their quality of life. These priorities encompassed enhanced arm and hand function, improved bladder and bowel control, sexual function, and the nurturing of personal relationships with their families and friends.

In this context, the investigators posit that augmenting standard treatment with expansion duraplasty has the potential to address several critical aspects of TSCI. Our hypothesis centers on the idea that the incorporation of duraplasty into the treatment regimen can lead to a reduction in spinal cord compression, an enhancement in Spinal Cord Perfusion Pressure (SCPP), an amelioration in spinal cord metabolism, and a mitigation of inflammation at the injury site. The investigatorsanticipate that these physiological and metabolic enhancements will contribute to increased neuronal survival, ultimately resulting in improved motor outcomes. These improved motor outcomes, in turn, are expected to translate into enhanced limb function, superior bladder and bowel control, and an overall improvement in the quality of life for the patients.

Our investigative focus encompasses a comprehensive examination of the impact of duraplasty on various facets of spinal cord physiology, metabolism, inflammation, motor and sensory performance, and Health-Related Quality of Life (HRQoL) measures. These HRQoL measures encompass aspects such as hand function, ambulation, bladder and bowel function, as well as the mental, emotional, and social well-being of the patients.

In the north area of R.O.C, individuals with TSCI are initially admitted to Linkou Chang Guan Memorial Hospital, where they typically undergo surgery involving spinal instrumentation (e.g., screws and rods) to address deformities and instability. Bony decompression, typically carried out through laminectomy, is a common surgical intervention aimed at addressing the adverse effects of bony compression on the spinal cord. It is worth noting that a significant majority of surgeons (ranging from 85% to 96%) advocate for bony decompression as a primary treatment for TSCI, as recommended by the National Institute for Health and Care Excellence (NICE) guidelines in 2016. However, the effectiveness of bony decompression in improving outcomes following TSCI remains a topic of debate and uncertainty, largely due to the absence of robust evidence from randomized controlled trials (RCTs).

Our proposal suggests that bony decompression in isolation may offer only partial relief to the swollen and injured spinal cord, which continues to experience compression against the dura. This may explain the persisting uncertainty surrounding the benefits of bony decompression in TSCI treatment. Achieving adequate cord decompression through surgical intervention assumes particular importance in this context, given the lack of pharmaceutical treatments proven to enhance outcomes in individuals with acute and severe TSCI. While the administration of methylprednisolone initially showed promise, subsequent trials, observational studies, and meta-analyses have cast doubt on its efficacy and raised concerns about potential harm.

The management of TSCI in the R.O.C is characterized by considerable variation among major trauma centers, encompassing diverse practices related to factors such as target blood pressure, choice of anesthetic agents, extent of monitoring (including the use of arterial and central lines), and timing of surgery. To circumvent these controversies and differences in practice, the "The outcome of Injured cervical Spinal Cord with Uncontrolled Swelling under Duraplasty" trial has been meticulously designed in a single major trauma center to allow participating surgeon can follow the same protocol about time to surgery and medically management.

The "The outcome of Injured cervical Spinal Cord with Uncontrolled Swelling under Duraplasty" trial was conceived with the aim of addressing these critical questions surrounding TSCI management, ultimately seeking to improve the outcomes and quality of life for individuals grappling with this challenging condition.

調査の概要

研究の種類

介入

入学 (推定)

104

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。

研究連絡先

研究場所

    • Taiwan
      • Taoyuan、Taiwan、台湾、333
        • 募集
        • Ying-Ching Li

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age ≥18 years
  • Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)
  • Deemed to require and be suitable for surgery that includes laminectomy or diskectomy by local surgeon
  • Surgery within 72 hours of traumatic spinal cord injury
  • Able to provide informed consent or consultee declaration or proxy consent

Exclusion Criteria:

  • Life-limiting or rehabilitation-restricting co-morbidities
  • Thoracic or lumbar traumatic spinal cord injury
  • Probable dural tear due to injury
  • Other central nervous system disease

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
実験的:Laminectomy with Duroplasty

Duroplasty

The investigators open the dura from midline and repaired with fish mouth for dura augmentation

介入なし:Laminectomy only

laminectomy without duroplasty

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
Delta-AMS
時間枠:6 months post-randomisation minus pre-operative baseline

The change in American Spinal Injury Association Impairment Scale (AIS) motor score. We also call it Delta-AMS, and the maximum is 100 and the minimum is 0. If the Delta-AMS is higher then it mean the patient has better recovery of the muscle power regained and vice versa.

6 months post-randomisation minus pre-operative baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
CUE-Q
時間枠:3, 6 and 12 month

Capabilities of Upper Extremity Test (CUE-Q) [Maximum= 128, Minimum: 0, Higher the better]

3, 6 and 12 month
WISCI-II
時間枠:3, 6 and 12 month

Walking Index for Spinal Cord Injury (WISCI-II) [Level 0--20, the higher level the better outcome]

3, 6 and 12 month
SCIM-II
時間枠:3, 6 and 12 month

Spinal Cord Independence Measure (SCIM-II) [Maximum: 100, Minimum:0, the higher score the better outcome] [weight in kilograms, height in meters]

3, 6 and 12 month
SF-36
時間枠:3, 6 and 12 months.

life quality the evaluation scale is not the simple meaning of score, there are eight category of the scale, and each has it's specific score sum of the scale .

for example the [Physical functioning, PF] is the sum of the question 3, and the maximum and minimum are 30 and 10 respectively.

3, 6 and 12 months.

協力者と研究者

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出版物と役立つリンク

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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5月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2024年7月16日

QC基準を満たした最初の提出物

2024年8月12日

最初の投稿 (実際)

2024年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月22日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

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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