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Sponsored by: |
BioSurface Engineering Technologies, Inc |
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Information provided by: | BioSurface Engineering Technologies, Inc |
ClinicalTrials.gov Identifier: | NCT00798239 |
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.
Condition | Intervention | Phase |
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Degenerative Disc Disease Spondylolisthesis |
Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules Other: Iliac crest autograft |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator
The control arm is Iliac Crest Autograft
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Other: Iliac crest autograft
autograft
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Prefix 150: Experimental
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
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Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
150 micorgrams/cc BVF
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Prefix 750: Experimental
Prefix (AMPLEX) B2A Enhanced Ceramic Granules
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Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
750 micrograms/cc BVF
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Not available
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brent Atkinson, PhD | 301-795-6000 |
Canada, Alberta | |
Confidential | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, Ontario | |
Confidential | Recruiting |
Ottawa, Ontario, Canada, K1Y 4E9 | |
Canada, Quebec | |
Confidential | Recruiting |
Montreal, Quebec, Canada, H3G 1A4 |
Study Director: | Brent Atkinson, PhD | BioSurface Engineering Technologies, Inc |
Responsible Party: | BioSET ( BioSurface Engineering Technologies, Inc. (BioSET) ) |
Study ID Numbers: | PFX-101 |
Study First Received: | November 24, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00798239 History of Changes |
Health Authority: | Canada: Health Canada |
DDD Spondylolisthesis Spine Fusion Lumbar Spine Bone Graft |
Spinal Diseases Musculoskeletal Diseases Spondylolisthesis Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Spondylolisthesis Bone Diseases |