INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
Condition: Lumbar Spine Degeneration
Intervention: INFUSE Bone Graft; Iliac Crest Bone Graft
Intervention description: Subjects enrolled in the investigational treatment group will receive surgical treatment with INFUSE® Bone Graft, the CAPSTONE® Spinal System, and posterior supplemental fixation (in this study the CD HORIZON® Spinal System). The investigational treatment will be implanted using a TLIF surgical approach.; Subjects enrolled in the control group will receive the same surgical treatment as the investigational group, including the CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System), except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. A TLIF surgical approach will also be used for implanting the control treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced degenerative disease of the lumbosacral spine; lumbosacral spine; radiculopathy; degenerative instability; spondylolisthesis; retrolisthesis; lateral listhesis; spinal stenosis; disc herniation; INFUSE Bone Graft; CD HORIZON Spinal System; CAPSTONE Spinal System

Summary:

      This investigation will provide safety and effectiveness information on the use of INFUSE®
      Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a
      Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels
      from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has advanced degenerative disease of the lumbosacral spine (L2 to S1) that results in
             radiculopathy secondary to nerve root compression, manifested by, History of radiating
             leg or buttock pain, paresthesias, numbness or weakness, or History of neurogenic
             claudication.

          -  Has a history of low back pain

          -  Has radiographic evidence of advanced degenerative lumbosacral disease, such as
             decreased disc height; herniated nucleus pulposus; hypertrophy or thickening of the
             ligamentum flavum, annulus fibrosis, or facet joint capsule; hypertrophied facet
             joints, facet joint space narrowing, or facet periarticular osteophyte formation;
             trefoil canal shape; or lateral(subarticular) stenosis; or vertebral endplate
             osteophyte formation; and at least one of the following:

        Sagittal plane translation (slippage) of the superior (cranial) vertebral body anterior or
        posterior to the inferior (caudal) vertebral body greater than 3mm, or Coronal plane
        translation (slippage) of the superior (cranial) vertebral body lateral to the inferior
        (caudal) vertebral body greater than 3mm, or Narrowing (stenosis) of the lumbar spinal
        canal and/or intervertebral foramen

          -  Has single-level or adjacent two-level involvement from L2 to S1.

          -  Has preoperative Oswestry score ≥30.

          -  Has preoperative back pain score of ≥ 6 based on the Preoperative Back and Leg Pain
             Questionnaire (pain intensity + pain frequency).

          -  Has preoperative leg pain score of ≥ 6 based on the Preoperative Back and Leg Pain
             Questionnaire (pain intensity + pain frequency).

          -  Is at least 18 years of age and skeletally mature at the time of surgery.

          -  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.

          -  Is willing and able to comply with the study plan and able to understand and sign the
             Subject Informed Consent Form.

        Exclusion Criteria:

          -  Requires spinal fusion at more than two lumbar levels or at two non-adjacent levels.

          -  Has had a prior lumbar surgical fusion procedure at the involved or adjacent spinal
             levels.

          -  Has significant lumbar instability, defined as sagittal or coronal plane listhesis
             greater than Grade 2 spondylolisthesis utilizing Meyerding's Classification
             (Meyerding, HW, 1932).

          -  Has scoliosis greater than 30 degrees.

          -  Has had a previous diagnosis of osteoporosis, osteopenia, or osteomalacia.

          -  In addition, if the subject has any of the following risk factors, a DEXA scan should
             be performed to determine eligibility:

        History of a non-traumatic hip or spine fracture. Female who is postmenopausal. Female over
        the age of 65. Male over the age of 70. If the DEXA T-score is -2.5 or lower, OR a T-score
        of -1.5 or lower WITH a history of a vertebral compression fracture, the subject is
        excluded.

          -  Is morbidly obese, as defined as a Body Mass Index (BMI) > 40.

          -  Has an active malignancy or prior history of malignancy (except for basal cell
             carcinoma of the skin).

          -  Has an overt or active bacterial infection, either local or systemic.

          -  Has undergone systemic administration of any type of corticosteroid, anti-neoplastic,
             immunostimulating, or immunosuppressive agents within 30 days prior to implantation of
             the assigned treatment.

          -  Has a history of clinically significant cardiac or hematologic disease.

          -  Has a history of autoimmune disease known to affect bone metabolism or the spine.
             Examples include spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease,
             and ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Grave's disease,
             and Hashimoto's thyroiditis.

          -  Has a medical disease or condition that would preclude accurate clinical evaluation of
             the safety and effectiveness of the treatments in this study, such as motor weakness,
             sensory loss, or painful conditions that inhibit normal ambulation or other activities
             of daily living.

          -  Has a history of any endocrine or metabolic disorder known to affect osteogenesis
             (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis
             imperfecta).

          -  Has chronic or acute renal and/or hepatic failure or prior history of renal and/or
             hepatic parenchymal disease.

          -  Has a history of exposure to injectable collagen.

          -  Has received any previous exposure to any/all BMPs of either human or animal
             extraction.

          -  Has a history of hypersensitivity to collagen or protein pharmaceuticals (e.g.,
             monoclonal antibodies or gamma globulins).

          -  Has a history of any allergy resulting in anaphylaxis.

          -  Has a history of allergy to bovine products.

          -  Has a documented allergy or intolerance to titanium, titanium alloy, tantalum,
             tantalum alloy, or polyetheretherketone (PEEK).

          -  Has any condition in which MRI scans are contraindicated (e.g., cardiac pacemaker,
             brain aneurysm clips).

          -  Has any condition in which a gadolinium-contrast MRI is contraindicated (e.g., sickle
             cell anemia, renal failure).

          -  Is mentally incompetent. If questionable, obtain psychiatric consult.

          -  Has a 'Waddell Signs of Inorganic Behavior' score of 3 or greater.

          -  Is a prisoner.

          -  Is a tobacco user who does not agree to suspend tobacco use prior to surgery.

          -  Is an alcohol and/or drug abuser as defined by currently undergoing treatment for
             alcohol and/or drug abuse.

          -  Has received treatment with an investigational therapy (drug, device and/or biologic)
             within 28 days prior to implantation surgery or such treatment is planned during the
             24-month period following the study surgery.

          -  Is pregnant or nursing. Female of child-bearing potential must agree not to become
             pregnant for one year following surgery.

          -  Is a Worker's Compensation case or is involved in spinal litigation.