Has a history of clinically significant cardiac or hematologic disease. 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 an overt or active bacterial infection, either local or systemic. Has an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). Is morbidly obese, as defined as a Body Mass Index (BMI) > 40. 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. 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. Has had a previous diagnosis of osteoporosis, osteopenia, or osteomalacia. Has significant lumbar instability, defined as sagittal or coronal plane listhesis greater than Grade 2 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932). Has had a prior lumbar surgical fusion procedure at the involved or adjacent spinal levels. Exclusion Criteria: - Requires spinal fusion at more than two lumbar levels or at two non-adjacent levels. Is willing and able to comply with the study plan and able to understand and sign the Subject Informed Consent Form. 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 at least 18 years of age and skeletally mature at the time of surgery. Has preoperative leg pain score of ≥ 6 based on the Preoperative Back and Leg Pain Questionnaire (pain intensity + pain frequency). Has preoperative back pain score of ≥ 6 based on the Preoperative Back and Leg Pain Questionnaire (pain intensity + pain frequency). 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. 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. A TLIF surgical approach will also be used for implanting the control treatment. 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. The investigational treatment will be implanted using a TLIF surgical approach. 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).
Infuse bone skin#
Operative time was recorded from skin incision to wound closureĭuring the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group Percent of Subjects Who Had Additional Surgical Procedures/Interventions Success Rate of Oswestry Disability Index All sites will follow a common Clinical Investigational Plan (CIP) that consists of the protocol and accompanying case report forms, risk analysis, investigator's agreement, subject informed consent, institutional review board (IRB) certification, labeling, and monitoring information. Control group subjects will receive the same surgical treatment except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. The study is a prospective, multi-national study that compares INFUSE® Bone Graft (investigational group) to autogenous bone graft (control group).
0 kommentar(er)
