Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

NCT01294007 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-11-02

Study results available
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Summary

The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

BIOLOGICAL

PureGen Osteoprogenitor Cell Allograft

PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.

PROCEDURE

Autograft bone

Iliac Crest and Local Autograft Bone

Sponsors & Collaborators

  • Alphatec Spine, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01294007 on ClinicalTrials.gov