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A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
NCT03118505 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, 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 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 35 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 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. 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: NCT03118505 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Colorado, Florida, Indiana. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03118505?
The interventions under investigation include: Infuse Bone Graft (DEVICE), Medtronic DBM (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03118505?
This trial is sponsored by Medtronic Spinal and Biologics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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