Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around
Principal Investigator
by Michael Oh

Description

Summary

This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively.

Overall a maximum of 1017 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.

Official Title

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

Keywords

Degenerative Disease of the Lumbosacral Spine, Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems

Eligibility

Locations

  • University of California Irvine accepting new patients
    Irvine California 92617 United States
  • Memorial Health Services terminated
    Laguna Hills California 92653 United States
  • Cedars Sinai Spine Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UC Irvine

  • Michael Oh
    Clinical Professor, Neurosurgery, School of Medicine. Authored (or co-authored) 97 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Spinal and Biologics
ID
NCT04073563
Study Type
Interventional
Participants
Expecting 1017 study participants
Last Updated