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Transforaminal Lumbar Interbody Fusion (TLIF) IDE

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Prospective, Randomized, Controlled, Blinded Pivotal 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.

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This research study is led by Dennis Oh, MD.

Contact: Jessica Vegerano, 413-794-3097

Participation Details:

Active Date: August 27, 2021

IRB Number: 1536407

Condition/Disease: Neurosurgery

Location: Baystate Medical Center

Purpose:
The purpose of this study is to evaluate the safety and effectiveness of the Investigational treatment as compared to the control and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.

Eligibility:

Inclusion:

  • Has radiographic evidence (i.e. CT or MRI within 12 months of enrollment*) of degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to root compression, manifested by:
    • History of radiating le or buttock pain, paresthesia, numbness, or weakness, or
    • History of neurogenic claudication.
  • Has a history of low back
  • Has preoperative Oswestry Disability Index score ≥ 35.
  • Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.

Exclusion:

  • Prior surgical procedure at the involved or adjacent spinal levels (e.g. bony decompression, fusion, arthroplasty, and/or other non-fusion procedures).Prior discectomy and/or laminectomy at the target or adjacent levels is allowed.
  • Planned use of an internal or external bone growth stimulator.
  • Lumbar scoliosis > 30 degrees.
  • Morbidly obese, as defined by a Body Mass Index (BMI >40.
  • Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).

Time Commitment: Expected to be 60 months.

Status: Active

Current Trial Type: Neurosurgery

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