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Synthetic Bone Substitute

Bone graft substitute for Degenerative Disc Disease

N/A
Waitlist Available
Led By Michael Janssen, MD / DO
Research Sponsored by CeraPedics, 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
Awards & highlights
No Placebo-Only Group

Summary

The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..

Eligible Conditions
  • Degenerative Disc Disease

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in of the Overall Neck Disability Index (NDI) Score From Baseline.
Complications
Neurologic Success
+1 more
Secondary study objectives
Kyphosis
Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
Mean Change in Pain at Neck Visual Analog Scale (VAS).
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bone graft substituteExperimental Treatment1 Intervention
Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
Group II: Autologous BoneActive Control1 Intervention
Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
P-15 Synthetic osteoconductive bone substitute
2006
N/A
~320

Find a Location

Who is running the clinical trial?

CeraPedics, IncLead Sponsor
5 Previous Clinical Trials
1,040 Total Patients Enrolled
Michael Janssen, MD / DOPrincipal InvestigatorSpine Education Research Institute
~16 spots leftby Nov 2025
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