The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.
Two hundred non-randomized subjects will participate in the study at up to ten clinical sites in the United States. Participants will be between 18 and 75 years of age. All subjects will have been established with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon. The diseases included in the study are spondylosis, degenerative disc disease and spondylolisthesis. All subjects who meet the inclusion criteria and do not meet the exclusion criteria and who elect to participate and sign the informed consent will be included in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.
Allograft derived from human amnion and amniotic fluid
Florida Orthopaedic Insitute
Tampa, Florida, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Carolina Neurosurgery & Spine
Charlotte, North Carolina, United States
Fusion rate using non-contrast CT of the lumbar spine
Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality
Time frame: 2 years
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