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Study of Nucel for One and Two Level Lumbar Interbody Fusion

Degenerative Disc Disease Clinical Trial

Official title:
A Single-arm, Prospective, Multi-center Study of Nucel® in Patients Receiving Interbody Fusion for One and Two Level Degenerative Disease of the Lumbar Spine

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02808234
Study type Interventional
Source Organogenesis
Contact
Status Active, not recruiting
Phase N/A
Start date December 2015
Completion date December 2022
View Details
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