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Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion

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

  • Clinical Trial Information

    Trial Contact: Carlo, Charlene S

    Trial Phone: 3218411324

  • IRB No: 20.007.01

    Protocol Abbrev: TLIF

    Principal Investigator: Virgilio Matheus, MD

    Phase: Device: Category B

    Age Group: Adult

    Secondary Protocol No: MDT17074SD1706

    Treatment: Transforaminal Lumbar Interbody Fusion (TLIF) with Infuse will be used as treatment for symptomatic degenerative disease of the lumbosacral spine at one or two adjacent lumbar levels from L2-S1.

    Therapies Involved: Surgery

    ClinicalTrials.gov ID: NCT04073563

  • Objective

    Evaluate the safety and effectiveness of the investigational treatment (Infuse) as compared to control group and to obtain approval for Infuse to be used in level one and two TLIF procedures.

  • Key Eligibility

    Subject must have degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression.