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

Degenerative Disc Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00798902
Study type Interventional
Source BioSurface Engineering Technologies, Inc
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 2008
Completion date October 2012
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