Efficacy of Using Solum IV and BMC With GFC in TLIF (NCT03223701) | Clinical Trial Compass
WithdrawnPhase 4
Efficacy of Using Solum IV and BMC With GFC in TLIF
Stopped: Study was never initiated due to contracting issues
United States0Started 2017-09-30
Plain-language summary
The purpose of this study is to examine the efficacy of using Solum IV and bone marrow concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is skeletally mature and older than 18 years of age
✓. One and contiguous 2 or 3 level primary lumbar fusions.
✓. L1 to S1 with a primary diagnosis of one or more of the following:
✓. Degenerative disc disease,
✓. Isthmic-lytic spondylolisthesis,
✓. Degenerative spondylolisthesis
✓. Spinal stenosis.
✓. Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive
Exclusion criteria
✕. Previous bilateral Iliac Crest Bone Graft (ICBG) harvest
✕. Previous instrumented fusion at the same or adjacent level
✕. Active systemic infection, infection localized to the site of implantation or at aspiration site