NCT00798239

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

A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety and Preliminary Effectiveness Of Prefix Compared To Iliac Crest Bone In Subjects With DDD Undergoing Transforaminal Lumbar Interbody Fusion

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: BioSurface Engineering Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2008-11-26
• Last updated: 2012-03-09

Locations

5 sites across 1 country: Canada