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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: Active NA study of Multi-Level Degenerative Lumbosacral Spinal Conditions, sponsored by Medtronic Spinal and Biologics.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Fusion at each treated level is defined as radiological fusion assessed by radiograph and CT. A subject will be considered a fusion success when the following criteria are met for each treated level: * Bilateral bridging bone (superior transverse process to the inferior transverse process) at each treated level (CT); * No more than 3mm translational motion and less than 5 degrees in angular motion at each treated level (flexion/extension radiographs); and * Absence of cracking, as evidenced by

Conditions Studied

Multi-Level Degenerative Lumbosacral Spinal Conditions

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
Medtronic Spinal and Biologics

26 total trials

What the registry record for NCT03118505 still lists

NCT03118505 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

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 lists 17 locations in 11 states (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.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT03118505's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03118505, the US trial registry maintained by the National Library of Medicine. NCT03118505 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.