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Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

NCT02070484 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-28

Study results available
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Summary

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

Conditions

  • Lumbar Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis
  • Spondylosis
  • Intervertebral Disk Displacement
  • Intervertebral Disk Degeneration
  • Spinal Diseases
  • Bone Diseases
  • Musculoskeletal Diseases
  • Spondylolysis

Interventions

BIOLOGICAL

NuCel

BIOLOGICAL

Demineralized Bone Matrix

Sponsors & Collaborators

  • NuTech Medical, Inc

    collaborator INDUSTRY

  • OhioHealth

    lead OTHER

Principal Investigators

  • Joseph Shehadi, MD · OhioHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-03-24
Completion
2017-03-24

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 NCT02070484 on ClinicalTrials.gov