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NCT00310440 · ClinicalTrials.gov registry record · NA
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
A NA study, sponsored by CeraPedics.
- Completed
- Registry status
- NA
- Development phase
- 319
- Enrollment target
NCT00310440: Completed NA study, sponsored by CeraPedics.
NCT00310440 is a NA study that has completed, run by CeraPedics. The registered enrollment target is 319 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00310440, a NA study, has completed, sponsored by CeraPedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 319 participants
- Enrollment target
Study Summary
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..
Primary Outcome
Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion \<3mm, and angular motion \<5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and
Interventions
- DEVICE P-15 Synthetic osteoconductive bone substitute
- OTHER Autologous bone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2006-01 |
| Est. Completion | 2019-05-23 |
| Phase | NA |
What the finished NCT00310440 record still lists
NCT00310440 is an interventional study that assigns participants to a tested intervention. The registered 319 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 (77% lower).
The record links to 0 conditions, and to 2 interventions - of which P-15 Synthetic osteoconductive bone substitute is the first listed.
NCT00310440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00310440 about?
NCT00310440 is a clinical study titled "An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation". The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with ...
What is the current status of trial NCT00310440?
This trial is currently completed. It is a NA study. The enrollment target is 319 participants. The study started on 2006-01. Estimated completion is 2019-05-23.
What interventions are being tested in trial NCT00310440?
The interventions under investigation include: P-15 Synthetic osteoconductive bone substitute (DEVICE), Autologous bone (OTHER).
Who is sponsoring clinical trial NCT00310440?
This trial is sponsored by CeraPedics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00310440's enrollment target sits among peer trials
319 321st of 2000 higher than 1,680 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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