INFUSEĀ®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacrā¦ (NCT01415908) | Clinical Trial Compass
TerminatedPhase 3
INFUSEĀ®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
Stopped: Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique
United States15 participantsStarted 2011-07
Plain-language summary
This investigation will provide safety and effectiveness information on the use of INFUSEĀ® Bone Graft with the CAPSTONEĀ® Spinal System and CD HORIZONĀ® 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.
Who can participate
Age range18 Years
SexALL
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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 ā„30.
* Has preoperative back pain score of ā„ 6 based on the Preoperative Back and Leg Pain Questionnaire (pain intensity + pain frequency).
* Has preoperative leg pain score of ā„ 6 based on the Preoperative Back and Leg ā¦