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Bone Graft

Prefix 150 for Spondylolisthesis

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
Be older than 18 years old
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
  • Spondylolisthesis
  • Degenerative Disc Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone Transplantation
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Prefix 750Experimental Treatment1 Intervention
Prefix (AMPLEX) B2A Enhanced Ceramic Granules
Group II: Prefix 150Experimental Treatment1 Intervention
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
Group III: ControlActive Control1 Intervention
The control arm is Iliac Crest Autograft

Find a Location

Who is running the clinical trial?

BioSurface Engineering Technologies, IncLead Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Spondylolisthesis
22 Patients Enrolled for Spondylolisthesis
Brent Atkinson, PhDStudy DirectorBioSurface Engineering Technologies, Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
2008. "Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00798239.
All > Degenerative Disc Disease
~1 spots leftby Apr 2025
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