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3Spine Lumbar Fusion Real World Evidence Study
NCT04823858 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).
Conditions Studied
Interventions
- PROCEDURE Lumbar Interbody Fusion
Study Locations (20)
Colorado
- University of Colorado — Aurora
- Steamboat Orthopedics and Spine Institute (SOSI) — Steamboat Springs
Florida
- Spine & Orthopedic Center — Deerfield Beach
- Florida Orthopaedic Institute — Temple Terrace
Louisiana
- The Spine Center of Louisiana — Baton Rouge
- Spine Institute of Louisiana — Shreveport
New York
- Upstate Orthopedics — East Syracuse
- NYU Langone, Spine Research Center — New York
North Carolina
- Carolina Neurosurgery and Spine Associates — Charlotte
- Pinehurst Surgical Clinic — Pinehurst
Ohio
- Vertrae — Miamisburg
- OrthoNeuro — New Albany
California
- Todd Lanman MD, Inc. — Beverly Hills
Kentucky
- Strenge Spine Institute — Paducah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2029-11-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04823858
The ClinicalTrials.gov registry entry for NCT04823858 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 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 3Spine, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lumbar Spine Degeneration appearing as the primary indexed condition, and to 1 intervention — of which Lumbar Interbody Fusion 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: NCT04823858 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Colorado, Florida, Louisiana. 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 NCT04823858 about?
NCT04823858 is a clinical study titled "3Spine Lumbar Fusion Real World Evidence Study". This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinica...
What is the current status of trial NCT04823858?
This trial is currently active not recruiting. The enrollment target is 176 participants. The study started on 2021-05-25. Estimated completion is 2029-11-15.
What conditions does trial NCT04823858 study?
This clinical trial studies the following conditions: Lumbar Spine Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04823858?
The interventions under investigation include: Lumbar Interbody Fusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04823858?
This trial is sponsored by 3Spine, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04823858 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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