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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

May 31, 2012

Study Completion Date

July 31, 2012

Conditions
Degenerative Disc DiseaseSpondylolisthesis
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

Trial Locations (5)

T2N 2T9

Confidential, Calgary

B3H 3A7

Confidential, Halifax

K1Y 4E9

Confidential, Ottawa

M4N 3M5

Confidential, Toronto

H3G 1A4

Confidential, Montreal

All Listed Sponsors
lead

BioSurface Engineering Technologies, Inc

INDUSTRY