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NCT00478088 · ClinicalTrials.gov registry record · NA
Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease
A NA study, sponsored by NuVasive.
- Completed
- Registry status
- NA
- Development phase
- 488
- Enrollment target
NCT00478088 is a NA study that has completed, run by NuVasive. The registered enrollment target is 488 participants.
The verdict
NCT00478088, a NA study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- NA
- Development phase
- 488 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
Interventions
- DEVICE NeoDisc
- DEVICE Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00478088
The ClinicalTrials.gov registry entry for NCT00478088 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuVasive, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NeoDisc is the first listed.
NCT00478088 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00478088 about?
NCT00478088 is a clinical study titled "Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease". The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1)...
What is the current status of trial NCT00478088?
This trial is currently completed. It is a NA study. The enrollment target is 488 participants. The study started on 2006-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00478088?
The interventions under investigation include: NeoDisc (DEVICE), Instrumented Anterior Cervical Discectomy and Fusion (ACDF) (DEVICE).
Who is sponsoring clinical trial NCT00478088?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
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