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Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery

NCT00798239 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-03-09

No results posted yet for this study

Summary

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis

Interventions

DEVICE

Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

150 micorgrams/cc BVF

OTHER

Iliac crest autograft

autograft

DEVICE

Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

750 micrograms/cc BVF

Sponsors & Collaborators

  • BioSurface Engineering Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Brent Atkinson, PhD · BioSurface Engineering Technologies, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Canada

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 NCT00798239 on ClinicalTrials.gov