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NCT00637156 · ClinicalTrials.gov registry record · NA
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
A NA study, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- NA
- Development phase
- 397
- Enrollment target
NCT00637156: Completed NA study, sponsored by Medtronic Spinal and Biologics.
NCT00637156 is a NA study that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 397 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00637156, a NA study, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- NA
- Development phase
- 397 participants
- Enrollment target
Study Summary
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
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 (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."
Interventions
- DEVICE PRESTIGE LP device at two adjacent levels
- DEVICE Bi-level fusion with ATLANTIS Cervical Plate System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2006-06 |
| Est. Completion | 2018-02-01 |
| Phase | NA |
What the finished NCT00637156 record still lists
NCT00637156 is an interventional study that assigns participants to a tested intervention. The registered 397 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which PRESTIGE LP device at two adjacent levels is the first listed.
NCT00637156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00637156 about?
NCT00637156 is a clinical study titled "Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels". The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical t...
What is the current status of trial NCT00637156?
This trial is currently completed. It is a NA study. The enrollment target is 397 participants. The study started on 2006-06. Estimated completion is 2018-02-01.
What interventions are being tested in trial NCT00637156?
The interventions under investigation include: PRESTIGE LP device at two adjacent levels (DEVICE), Bi-level fusion with ATLANTIS Cervical Plate System (DEVICE).
Who is sponsoring clinical trial NCT00637156?
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 NCT00637156's enrollment target sits among peer trials
397 267th of 2000 higher than 1,733 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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