Clinical Trial

A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions

Active, Not Recruiting
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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.
Protocol Amendment History 42 amendments
This ClinicalTrials.gov record has been amended 42 times since 2017-04-17; most recent amendment 2026-06-04.
Status change: Recruiting → Active, Not Recruiting 2024-06-04
Status change: Active, Not Recruiting → Recruiting 2020-05-15
Status change: Recruiting → Active, Not Recruiting 2020-04-17
Status change: Not Yet Recruiting → Recruiting 2017-04-27
Trial Details
NCT Number NCT03118505
Lead Sponsor Medtronic Spinal and Biologics
Conditions Multi-Level Degenerative Lumbosacral Spinal Conditions
Enrollment 100 participants
Start Date 2017-06-29
Primary Completion 2025-07-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-25