Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry (SPIDER)
SPIDER - Spinal Dural Arteriovenous Fistula International Data and Outcomes Registry
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Pascal Jabbour, MD
- Telefonnummer: 215-955-7000
- E-post: pascal.jabbour@jefferson.edu
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19102
- Rekrytering
- Thomas Jefferson University Hospital
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Kontakt:
- Victor Gabriel El-Hajj, MD
- Telefonnummer: 215-955-7000
- E-post: victorgabriel.el-hajj2@jefferson.edu
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Type 1 spinal dural arteriovenous fistula, confirmed on imaging
- Surgically or endovascularly treated
- At least 1 available primary outcome
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Treatment success
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Modified Aminoff-Logue Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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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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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- SPIDER iRISID-2026-0174
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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