Last updated on May 2019

Study of Nucel for One and Two Level Lumbar Interbody Fusion

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02808234

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Spine Institute of Louisiana

Shreveport, LA United States
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