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NCT03118505 · ClinicalTrials.gov registry record · NA
A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
A NA study of Multi-Level Degenerative Lumbosacral Spinal Conditions, sponsored by Medtronic Spinal and Biologics.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT03118505 is a NA study of Multi-Level Degenerative Lumbosacral Spinal Conditions that is active but no longer recruiting, run by Medtronic Spinal and Biologics. The registered enrollment target is 100 participants. The trial reports 17 study locations across 11 states.
The verdict
NCT03118505, a NA study of Multi-Level Degenerative Lumbosacral Spinal Conditions, is active but no longer recruiting, sponsored by Medtronic Spinal and Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
Conditions Studied
Interventions
- DEVICE Infuse Bone Graft
- DEVICE Medtronic DBM
Study Locations (17)
Colorado
- Spine Colorado - Durango
- The Steadman Clinic - Vail
Florida
- The Spine Health Institute - Altamonte Springs
- Foundation for Orthopedic Research and Education - Tampa
Indiana
- Indiana Spine Group - Carmel
- Fort Wayne Orthopedics - Fort Wayne
New York
- Upstate Orthopedics - East Syracuse
- New York-Presbyterian Hospital/Columbia University - New York
Texas
- Seton Spine & Scoliosis Center - Austin
- American Neurospine Institute PLLC - Plano
Virginia
- University of Virginia Health System - Charlottesville
- University of Virginia - Charlottesville
California
- University of California, Davis - Sacramento
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03118505
The ClinicalTrials.gov registry entry for NCT03118505 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multi-Level Degenerative Lumbosacral Spinal Conditions appearing as the primary indexed condition, and to 2 interventions - of which Infuse Bone Graft is the first listed.
NCT03118505 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Colorado, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT03118505 about?
NCT03118505 is a clinical study titled "A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions". The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
What is the current status of trial NCT03118505?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2017-06-29. Estimated completion is 2026-12.
What conditions does trial NCT03118505 study?
This clinical trial studies the following conditions: Multi-Level Degenerative Lumbosacral Spinal Conditions.
What interventions are being tested in trial NCT03118505?
The interventions under investigation include: Infuse Bone Graft (DEVICE), Medtronic DBM (DEVICE).
Who is sponsoring clinical trial NCT03118505?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03118505 being conducted?
This trial has 17 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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