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NCT05648474 · ClinicalTrials.gov registry record
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
A clinical trial of Spondylolisthesis and Spinal Deformity, sponsored by Alphatec Spine.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT05648474: Recruiting study of Spondylolisthesis and Spinal Deformity, sponsored by Alphatec Spine.
NCT05648474 is a study of Spondylolisthesis and Spinal Deformity that is actively recruiting participants, run by Alphatec Spine. The registered enrollment target is 400 participants, above the 131-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (205% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05648474, a study of Spondylolisthesis and Spinal Deformity, is actively recruiting participants, sponsored by Alphatec Spine.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
Primary Outcome
This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Somatosensory evoked potential [SSEP] intraoperative monitoring
Study Locations (1)
California
- Alphatec Spine Inc. - Carlsbad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2025-12-31 |
What NCT05648474 shows while recruiting
NCT05648474 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 131-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (205% higher).
The record links to 5 conditions, with Spondylolisthesis appearing as the primary indexed condition, and to 1 intervention - of which Somatosensory evoked potential [SSEP] intraoperative monitoring is the first listed.
NCT05648474 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05648474 about?
NCT05648474 is a clinical study titled "Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure". This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
What is the current status of trial NCT05648474?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2022-07-13. Estimated completion is 2025-12-31.
What conditions does trial NCT05648474 study?
This clinical trial studies the following conditions: Spondylolisthesis, Spinal Deformity, Intervertebral Disc Degeneration, Spinal Instability, Stenosis, Spinal.
What interventions are being tested in trial NCT05648474?
The interventions under investigation include: Somatosensory evoked potential [SSEP] intraoperative monitoring (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05648474?
This trial is sponsored by Alphatec Spine, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05648474 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05648474's enrollment target sits among peer trials
400 2nd of 18 the highest of 18 other Spondylolisthesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spondylolisthesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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