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NCT00667459 · ClinicalTrials.gov registry record · Phase 3
Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD
A Phase 3 study, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT00667459: Completed Phase 3 study, sponsored by Medtronic Spinal and Biologics.
NCT00667459 is a Phase 3 study that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 280 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667459, a Phase 3 study, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
Primary Outcome
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; 2. Maintenance or improvement in neurological status; 3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of "Postoperative Height - 6 Week Postoperative Height ≥ -2mm"; 4. No serious adverse event classified as implant associated
Interventions
- DEVICE PRESTIGE® LP Cervical Disc
- DEVICE ATLANTIS Anterior Cervical Plate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2005-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00667459 record still lists
NCT00667459 is an interventional study that assigns participants to a tested intervention. The registered 280 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which PRESTIGE® LP Cervical Disc is the first listed.
NCT00667459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00667459 about?
NCT00667459 is a clinical study titled "Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD". The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
What is the current status of trial NCT00667459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2005-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00667459?
The interventions under investigation include: PRESTIGE® LP Cervical Disc (DEVICE), ATLANTIS Anterior Cervical Plate (DEVICE).
Who is sponsoring clinical trial NCT00667459?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00667459's enrollment target sits among peer trials
280 1195th of 2000 higher than 802 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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