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NCT00437190 · ClinicalTrials.gov registry record · NA
Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
A NA study, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- NA
- Development phase
- 494
- Enrollment target
NCT00437190: Completed NA study, sponsored by Medtronic Spinal and Biologics.
NCT00437190 is a NA study that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 494 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00437190, a NA study, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- NA
- Development phase
- 494 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.
Primary Outcome
The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
Interventions
- DEVICE ATLANTIS™ Cervical Plate System and allograft
- DEVICE BRYAN Cervical Disc Prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2003-06 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT00437190 record still lists
NCT00437190 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which ATLANTIS™ Cervical Plate System and allograft is the first listed.
NCT00437190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00437190 about?
NCT00437190 is a clinical study titled "Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF". The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.
What is the current status of trial NCT00437190?
This trial is currently completed. It is a NA study. The enrollment target is 494 participants. The study started on 2003-06. Estimated completion is 2016-05.
What interventions are being tested in trial NCT00437190?
The interventions under investigation include: ATLANTIS™ Cervical Plate System and allograft (DEVICE), BRYAN Cervical Disc Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT00437190?
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 NCT00437190's enrollment target sits among peer trials
494 213th of 2000 higher than 1,788 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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