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NCT02949245 · ClinicalTrials.gov registry record
Neurologic Complications in Spinal Deformity Surgery - Extension
A clinical trial, sponsored by AO Foundation, AO Spine.
- Completed
- Registry status
- 77
- Enrollment target
NCT02949245 is a clinical trial that has completed, run by AO Foundation, AO Spine. The registered enrollment target is 77 participants.
The verdict
NCT02949245 has completed, sponsored by AO Foundation, AO Spine.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study Summary
272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits. Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery. All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.
Interventions
- PROCEDURE Interventions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2019-12-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02949245
The ClinicalTrials.gov registry entry for NCT02949245 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AO Foundation, AO Spine, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interventions is the first listed.
NCT02949245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02949245 about?
NCT02949245 is a clinical study titled "Neurologic Complications in Spinal Deformity Surgery - Extension". 272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion ...
What is the current status of trial NCT02949245?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2017-08-17. Estimated completion is 2019-12-28.
What interventions are being tested in trial NCT02949245?
The interventions under investigation include: Interventions (PROCEDURE).
Who is sponsoring clinical trial NCT02949245?
This trial is sponsored by AO Foundation, AO Spine, which has 9 total clinical trials registered on ClinicalTrials.gov.
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