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NCT01905930 · ClinicalTrials.gov registry record · Phase 3
Post-Approval Clinical Trial of the PCM® Cervical Disc
A Phase 3 study, sponsored by NuVasive.
- Completed
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT01905930: Completed Phase 3 study, sponsored by NuVasive.
NCT01905930 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
NCT01905930, a Phase 3 study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
Primary Outcome
* Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline * No device failures requiring revision, reoperation, removal or supplemental fixation * No major complications such as vascular or neurological injury * Radiographic success
Interventions
- DEVICE Anterior Cervical Discectomy and Fusion (ACDF)
- DEVICE PCM Cervical Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01905930 record still lists
NCT01905930 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.
NCT01905930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01905930 about?
NCT01905930 is a clinical study titled "Post-Approval Clinical Trial of the PCM® Cervical Disc". On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculop...
What is the current status of trial NCT01905930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2013-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01905930?
The interventions under investigation include: Anterior Cervical Discectomy and Fusion (ACDF) (DEVICE), PCM Cervical Disc (DEVICE).
Who is sponsoring clinical trial NCT01905930?
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 NCT01905930'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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