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Study of Nucel for One and Two Level Lumbar Interbody Fusion

NCT02808234 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-05-26

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Spondylosis

Interventions

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

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Pierce Nunley, MD · Spine Institute of Louisiana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808234 on ClinicalTrials.gov