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NCT04823858 · ClinicalTrials.gov registry record
3Spine Lumbar Fusion Real World Evidence Study
A clinical trial of Lumbar Spine Degeneration, sponsored by 3Spine.
- Active
- Registry status
- 176
- Enrollment target
- 20
- Study locations
NCT04823858: Active study of Lumbar Spine Degeneration, sponsored by 3Spine.
NCT04823858 is a study of Lumbar Spine Degeneration that is active but no longer recruiting, run by 3Spine. The registered enrollment target is 176 participants, below the 619-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04823858, a study of Lumbar Spine Degeneration, is active but no longer recruiting, sponsored by 3Spine.
- ACTIVE NOT RECRUITING
- Registry status
- 176 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.
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 |
What the registry record for NCT04823858 still lists
NCT04823858 is an observational study that tracks outcomes without assigning an intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 619-participant average among 7 other Lumbar Spine Degeneration trials with a reported enrollment target (72% lower).
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.
NCT04823858 names 20 study sites across 14 states, led by Colorado, Florida, Louisiana.
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.
What interventions are being tested in trial NCT04823858?
The interventions under investigation include: Lumbar Interbody Fusion (PROCEDURE).
Who is sponsoring clinical trial NCT04823858?
This trial is sponsored by 3Spine, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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