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
Details
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively.
Eligibility
You can join if...
Inclusion Criteria: (A subject must meet all of the following inclusion criteria to participate in this study)
Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by: History of radiating leg or buttock pain, paresthesia, numbness or weakness, or History of neurogenic claudication.
Has a history of low back pain.
Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or Recurrent disc herniation.
Has preoperative Oswestry Disability Index score greater than or equal to 35.
Has to meet either inclusion criteria 5 or 6 to qualify for the study:
Has preoperative back and leg pain scores of (back pain greater than or equal to 4 and leg pain greater than or equal to 1) based on the Preoperative Back and Leg Pain Questionnaire.
Has preoperative back and leg pain scores of (back pain greater than or equal to 1 and leg pain greater than or equal to 4) based on the Preoperative Back and Leg Pain Questionnaire.
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.
For exclusion criteria, please refer to treating center for more information.