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NCT01305343 · ClinicalTrials.gov registry record
Neurologic Complications in Spinal Deformity Surgery
A clinical trial, sponsored by AO Foundation, AO Spine.
- Completed
- Registry status
- 273
- Enrollment target
NCT01305343: Completed study, sponsored by AO Foundation, AO Spine.
NCT01305343 is a clinical trial that has completed, run by AO Foundation, AO Spine. The registered enrollment target is 273 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305343 has completed, sponsored by AO Foundation, AO Spine.
- COMPLETED
- Registry status
- 273 participants
- Enrollment target
Study Summary
240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention. Regression analyses will be 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.
Primary Outcome
* Spinal Cord Deficit * Cauda Equina Deficit * Nerve Root Deficit * Motor Deficit * Sensory Deficit * Radiculopathy
Interventions
- PROCEDURE Routinely performed surgical correction of spinal deformity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-03 |
What the finished NCT01305343 record still lists
NCT01305343 is an observational study that tracks outcomes without assigning an intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Routinely performed surgical correction of spinal deformity is the first listed.
NCT01305343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01305343 about?
NCT01305343 is a clinical study titled "Neurologic Complications in Spinal Deformity Surgery". 240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic c...
What is the current status of trial NCT01305343?
This trial is currently completed. The enrollment target is 273 participants. The study started on 2011-08. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01305343?
The interventions under investigation include: Routinely performed surgical correction of spinal deformity (PROCEDURE).
Who is sponsoring clinical trial NCT01305343?
This trial is sponsored by AO Foundation, AO Spine, which has 9 total clinical trials registered on ClinicalTrials.gov.
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