Transforaminal Lumbar Interbody Fusion (TLIF) (TLIF)

  • STATUS
    Recruiting
  • End date
    Jun 24, 2025
  • participants needed
    1017
  • sponsor
    Medtronic Spinal and Biologics
Updated on 24 July 2022
Investigator
Lindsey Mitchell, MS
Primary Contact
Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson (6.2 mi away) Contact
+32 other location

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.

Details
Condition Degenerative Disease of the Lumbosacral Spine
Treatment Infuse™ Bone Graft (Infuse™), Capstone™ Spinal System and Medtronic posterior Fixation Systems
Clinical Study IdentifierNCT04073563
SponsorMedtronic Spinal and Biologics
Last Modified on24 July 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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