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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 is a Phase 3 study that has completed, run by NuVasive. The registered enrollment target is 494 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578812
The ClinicalTrials.gov registry entry for NCT00578812 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 494 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 Anterior Cervical Discectomy and Fusion (ACDF) is the first listed.
NCT00578812 reports 0 study locations.
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.
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