CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
P-15 Synthetic osteoconductive bone substitute +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00310440
NCT00310440N/ACompleted
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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

CeraPedics, Inc·interventional·Posted Apr 4, 2006·Updated Mar 12, 2020

In Brief

A clinical study evaluating P-15 Synthetic osteoconductive bone substitute and Autologous bone for Intervertebral Disk Degeneration. Completed, enrolled 319 participants across 12 sites in 2 countries.

Detailed 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..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntervertebral Disk Degeneration
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 4, 2006
Enrollment StartJan 1, 2006
Primary CompletionMay 1, 2014
Study CompletionMay 23, 2019
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.2 years ago

Interventions

P-15 Synthetic osteoconductive bone substitutedevice

Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Autologous boneother

Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring