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NCT00456378 · ClinicalTrials.gov registry record · NA
Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care
A NA study, sponsored by Medtronic Spinal and Biologics.
- Terminated
- Registry status
- NA
- Development phase
- 311
- Enrollment target
NCT00456378: Clinical Trial NA study, sponsored by Medtronic Spinal and Biologics.
NCT00456378 is a NA study that was terminated before completion, run by Medtronic Spinal and Biologics. The registered enrollment target is 311 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00456378, a NA study, was terminated before completion, sponsored by Medtronic Spinal and Biologics.
- TERMINATED
- Registry status
- NA
- Development phase
- 311 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.
Primary Outcome
A patient will be considered an overall success if all of the following conditions are met: 1. Pain/disability (Oswestry) success; 2. No serious adverse event classified as "implant associated", "implant-/surgical procedure associated", or "nonoperative treatment associated"; and 3. For patients in the investigational group, no additional surgical procedure at the involved level classified as a failure. For patients in the control group, no "treatment surgery" at the involved level that was the
Interventions
- DEVICE DIAM™ Spinal Stabilization System
- PROCEDURE Conservative care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2006-12 |
| Est. Completion | 2018-11-20 |
| Phase | NA |
Why NCT00456378 stopped before completion
NCT00456378 is an interventional study that assigns participants to a tested intervention. The registered 311 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which DIAM™ Spinal Stabilization System is the first listed.
NCT00456378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00456378 about?
NCT00456378 is a clinical study titled "Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care". The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.
What is the current status of trial NCT00456378?
This trial is currently terminated. It is a NA study. The enrollment target is 311 participants. The study started on 2006-12. Estimated completion is 2018-11-20.
What interventions are being tested in trial NCT00456378?
The interventions under investigation include: DIAM™ Spinal Stabilization System (DEVICE), Conservative care (PROCEDURE).
Who is sponsoring clinical trial NCT00456378?
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 NCT00456378's enrollment target sits among peer trials
311 323rd of 2000 higher than 1,678 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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