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NCT03123549 · ClinicalTrials.gov registry record · NA
Investigation of the Two Level Simplify® Cervical Artificial Disc
A NA study, sponsored by NuVasive.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
NCT03123549: Completed NA study, sponsored by NuVasive.
NCT03123549 is a NA study that has completed, run by NuVasive. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123549, a NA study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
Study Summary
This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.
Primary Outcome
Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with
Interventions
- DEVICE Simplify Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2022-03-24 |
| Phase | NA |
What the finished NCT03123549 record still lists
NCT03123549 is an interventional study that assigns participants to a tested intervention. The registered 182 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 (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Simplify Disc is the first listed.
NCT03123549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03123549 about?
NCT03123549 is a clinical study titled "Investigation of the Two Level Simplify® Cervical Artificial Disc". This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for ...
What is the current status of trial NCT03123549?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2017-04-01. Estimated completion is 2022-03-24.
What interventions are being tested in trial NCT03123549?
The interventions under investigation include: Simplify Disc (DEVICE).
Who is sponsoring clinical trial NCT03123549?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123549's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 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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