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Bone Graft Substitute
Prefix 150 for Degenerative Disc Disease
Phase 1 & 2
Waitlist Available
Research Sponsored by BioSurface Engineering Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of DDD requiring single level fusion (L2-S1) with up to Grade I Spondylolisthesis
Have a preoperative screening qualifying VAS and ODI scores
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post surgery
Awards & highlights
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.
Eligible Conditions
- Degenerative Disc Disease
- Spondylolisthesis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Removal/revision or supplemental fixation of the graft material requiring reoperation at the index level, Safety (adverse events), Fusion "success" based on X-rays, Change from baseline in neurological exam scores and ODI scores
Secondary outcome measures
Volume of blood loss/transfused blood during surgery, Blinded independent assessment of fusion by CT and other radiographic assessments, Change from baseline in pain scores using VAS and change from baseline in SF-36 v2™ total and subscale scores
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prefix 150Experimental Treatment1 Intervention
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
Group II: ControlActive Control1 Intervention
Iliac Crest Autograft
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Who is running the clinical trial?
BioSurface Engineering Technologies, IncLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
David M Hooper, PhDStudy DirectorBioSurface Engineering Technologies, Inc
1 Previous Clinical Trials
24 Total Patients Enrolled
Frequently Asked Questions
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