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ACTIVE NOT RECRUITING

Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

NCT05258435 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 131 participants
Start Date 2022-02-09
Est. Completion 2028-04

Sponsor

NuVasive

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05258435

The ClinicalTrials.gov registry entry for NCT05258435 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuVasive, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05258435 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05258435?

The interventions under investigation include: NuVasive Simplify Cervical Artificial Disc (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05258435?

This trial is sponsored by NuVasive, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial