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NCT00627497 · ClinicalTrials.gov registry record · Phase 3
DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
A Phase 3 study, sponsored by Medtronic Spinal and Biologics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT00627497: Clinical Trial Phase 3 study, sponsored by Medtronic Spinal and Biologics.
NCT00627497 is a Phase 3 study that was terminated before completion, run by Medtronic Spinal and Biologics. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00627497, a Phase 3 study, was terminated before completion, sponsored by Medtronic Spinal and Biologics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
Primary Outcome
Rate of overall success is reported as the percentage of partipants who met all of the following criteria: 1. Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15); 2. Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated); 3. No serious adverse event classified as
Interventions
- PROCEDURE Single-Level Posterior Decompression
- DEVICE DIAM Spinal Stabilization
- DEVICE Fusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
Why NCT00627497 stopped before completion
NCT00627497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Single-Level Posterior Decompression is the first listed.
NCT00627497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00627497 about?
NCT00627497 is a clinical study titled "DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion". The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
What is the current status of trial NCT00627497?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2008-02. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00627497?
The interventions under investigation include: Single-Level Posterior Decompression (PROCEDURE), DIAM Spinal Stabilization (DEVICE), Fusion (DEVICE).
Who is sponsoring clinical trial NCT00627497?
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 NCT00627497's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 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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