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NCT05258435 · ClinicalTrials.gov registry record
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
A clinical trial of Degenerative Disc Disease and Cervical Disc Disease, sponsored by NuVasive.
- Active
- Registry status
- 131
- Enrollment target
- 10
- Study locations
NCT05258435: Active study of Degenerative Disc Disease and Cervical Disc Disease, sponsored by NuVasive.
NCT05258435 is a study of Degenerative Disc Disease and Cervical Disc Disease that is active but no longer recruiting, run by NuVasive. The registered enrollment target is 131 participants, below the 166-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (21% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05258435, a study of Degenerative Disc Disease and Cervical Disc Disease, is active but no longer recruiting, sponsored by NuVasive.
- ACTIVE NOT RECRUITING
- Registry status
- 131 participants
- Enrollment target
- 10
- Study locations
Study Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
Primary Outcome
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and 2. No device failures by month 120, and 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.
Conditions Studied
Interventions
- DEVICE NuVasive Simplify Cervical Artificial Disc
Study Locations (10)
California
- Hoag Orthopedics - Orange
- The Spine Institute for Spine Restoration - Santa Monica
Texas
- Texas Spine Consultants - Addison
- Texas Back Institute - Plano
Colorado
- Spine Education and Research - Thornton
Florida
- Kennedy-White Orthopaedic Center - Sarasota
Illinois
- NorthShore University Health System - Evanston
Indiana
- Indiana Spine Group - Carmel
Louisiana
- Spine Institute of Louisiana - Shreveport
North Carolina
- Carolina Neurosurgery and Spine Associates - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2022-02-09 |
| Est. Completion | 2028-04 |
What the registry record for NCT05258435 still lists
NCT05258435 is an observational study that tracks outcomes without assigning an intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 166-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (21% lower).
The record links to 2 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which NuVasive Simplify Cervical Artificial Disc is the first listed.
NCT05258435 lists 10 locations in 8 states (California, Texas, Colorado).
Frequently Asked Questions
What is clinical trial NCT05258435 about?
NCT05258435 is a clinical study titled "Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc". A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
What is the current status of trial NCT05258435?
This trial is currently active not recruiting. The enrollment target is 131 participants. The study started on 2022-02-09. Estimated completion is 2028-04.
What conditions does trial NCT05258435 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Cervical Disc Disease.
What interventions are being tested in trial NCT05258435?
The interventions under investigation include: NuVasive Simplify Cervical Artificial Disc (DEVICE).
Who is sponsoring clinical trial NCT05258435?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05258435 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05258435's enrollment target sits among peer trials
131 16th of 42 higher than 27 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease 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.
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