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NCT02108249 · ClinicalTrials.gov registry record
Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
A clinical trial of Degenerative Disc Disease and Adjacent Level Disease, sponsored by Spine Wave.
- Completed
- Registry status
- 35
- Enrollment target
- 1
- Study location
NCT02108249 is a study of Degenerative Disc Disease and Adjacent Level Disease that has completed, run by Spine Wave. The registered enrollment target is 35 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02108249, a study of Degenerative Disc Disease and Adjacent Level Disease, has completed, sponsored by Spine Wave.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
Conditions Studied
Interventions
- DEVICE Annex™ Adjacent Level System
Study Locations (1)
North Carolina
- Carolinas Neurosurgery and Spine - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-04 |
| Est. Completion | 2019-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108249
The ClinicalTrials.gov registry entry for NCT02108249 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (79% lower). The listed sponsor is Spine Wave, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Annex™ Adjacent Level System is the first listed.
NCT02108249 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02108249 about?
NCT02108249 is a clinical study titled "Annex™ Adjacent Level System for Treatment of Adjacent Level Disease". The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available...
What is the current status of trial NCT02108249?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2014-04. Estimated completion is 2019-12.
What conditions does trial NCT02108249 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Adjacent Level Disease.
What interventions are being tested in trial NCT02108249?
The interventions under investigation include: Annex™ Adjacent Level System (DEVICE).
Who is sponsoring clinical trial NCT02108249?
This trial is sponsored by Spine Wave, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02108249 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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