NCT02808234

Study of Nucel for One and Two Level Lumbar Interbody Fusion

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis
• Spondylosis

Interventions

Type	Name	Description
PROCEDURE	One or two level lumbar interbody fusion surgery	One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.
OTHER	Nucel	Allograft derived from human amnion and amniotic fluid

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-06-21
• Last updated: 2021-05-26

Locations

3 sites across 1 country: United States