Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)
SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry
調査の概要
状態
詳細な説明
Type 1 or dural spinal arteriovenous fistulas (SDAVFs) are the most common spinal vascular malformation but remain frequently underdiagnosed due to their insidious onset and nonspecific clinical presentation. Delayed diagnosis is common and often results in progressive, and sometimes irreversible, myelopathy. Despite advances in imaging and treatment, there remains significant variability in diagnostic timelines, treatment strategies (endovascular, surgical, or combined), and reported outcomes across institutions.
Existing literature is largely limited to single-center retrospective series or small cohorts, often underpowered to evaluate predictors of outcome, recurrence, and the impact of diagnostic delay. Furthermore, direct comparisons between treatment modalities and long-term functional outcomes using standardized clinical scales are limited.
The SPIDER registry is designed to address these gaps by creating the largest international, multicenter dataset of patients with spinal dural AVFs. By pooling de-identified data from high-volume centers worldwide, this study aims to provide robust, generalizable evidence to inform clinical decision-making and optimize patient outcomes.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Pascal Jabbour, MD
- 電話番号:215-955-7000
- メール:pascal.jabbour@jefferson.edu
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19102
- 募集
- Thomas Jefferson University Hospital
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コンタクト:
- Victor Gabriel El-Hajj, MD
- 電話番号:215-955-7000
- メール:victorgabriel.el-hajj2@jefferson.edu
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Type 1 spinal dural arteriovenous fistula, confirmed on imaging
- Surgically or endovascularly treated
- At least 1 available primary outcome
研究計画
研究はどのように設計されていますか?
デザインの詳細
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 |
|---|---|---|
|
Treatment success
時間枠:Recorded at the end of the embolization or surgery.
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Complete surgical/endovascular obliteration of the fistula
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Recorded at the end of the embolization or surgery.
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Recurrence
時間枠:Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Fistula recurrence
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
|
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Status of symptoms at last clinical follow-up
時間枠:Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Improved, unchanged, or worsened pain, sensory, and motor symptoms
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
|
|
Modified Aminoff-Logue Scale
時間枠:Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Gait and bowel/bladder score
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Modified Rankin Scale
時間枠:Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Measure of functional independence
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Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
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Mortality
時間枠:Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
|
Time-to-event Outcome Measures. Estimated period of time over which the event is assessed: on average 1.5 years after surgery.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SPIDER iRISID-2026-0174
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。