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NCT00578812 · ClinicalTrials.gov registry record · Phase 3
PCM Cervical Disc System
A Phase 3 study, sponsored by NuVasive.
- Completed
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT00578812: Completed Phase 3 study, sponsored by NuVasive.
NCT00578812 is a Phase 3 study that has completed, run by NuVasive. The registered enrollment target is 494 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578812, a Phase 3 study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.
Primary Outcome
Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.
Interventions
- DEVICE Anterior Cervical Discectomy and Fusion (ACDF)
- DEVICE PCM Cervical Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2005-01 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT00578812 record still lists
NCT00578812 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Anterior Cervical Discectomy and Fusion (ACDF) is the first listed.
NCT00578812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00578812 about?
NCT00578812 is a clinical study titled "PCM Cervical Disc System". The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy an...
What is the current status of trial NCT00578812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2005-01. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00578812?
The interventions under investigation include: Anterior Cervical Discectomy and Fusion (ACDF) (DEVICE), PCM Cervical Disc (DEVICE).
Who is sponsoring clinical trial NCT00578812?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00578812's enrollment target sits among peer trials
494 779th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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