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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: Completed NA study, sponsored by NuVasive.

NCT00478088 is a NA study that has completed, run by NuVasive. The registered enrollment target is 488 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 488 participants
Start Date 2006-09
Est. Completion 2012-03
Phase NA
NuVasive

28 total trials

What the finished NCT00478088 record still lists

NCT00478088 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which NeoDisc is the first listed.

NCT00478088 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00478088's enrollment target sits among peer trials

488 215th of 2000 higher than 1,785 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00478088, the US trial registry maintained by the National Library of Medicine. NCT00478088 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.