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 Trea

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Degenerative Disease Of Lumbosacral Spine
  • Age: Between 18 - 85 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who has degenerative disease of the lumbosacral spine
    2. Participants with a history of radiating leg or buttock pain, paresthesia, numbness or weakness
    3. Those with a history of neurogenic claudication
    4. Participants who have a history of low back pain
    5. Those with radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease
    6. Has preoperative Oswestry Disability Index score = 40.
    7. Has preoperative back pain score of = 4 based on the Preoperative Back and Leg Pain Questionnaire.
    8. Has preoperative leg pain score of = 4
    9. At least 18 years of age and skeletally mature at the time of surgery.
    10. Participants have not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS)
    11. Participants who will comply to the study procedures and provide written signed informed consent

You may not be eligible for this study if the following are true:

    1. Participants with prior surgical procedure at the involved or adjacent spinal levels
    2. Significant lumbar instability
    3. Participants who plan to use of an internal or external bone growth stimulator
    4. Lumbar scoliosis >30 degrees.
    5. Participants who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below
    6. Morbidly obese, as defined by a Body Mass Index (BMI) >40.
    7. Participants with active malignancy or prior history of malignancy
    8. Overt or active bacterial infection
    9. Participants who use corticosteroid, anti-neoplastic, immunostimulating, or immunosuppressive agents, or medications known to interfere with the healing of bone or soft tissue



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