Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2017-06-29
Est. Completion 2026-12
Phase NA

Sponsor

Medtronic Spinal and Biologics

35 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. 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.

Related

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