MedTrace Logo

An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

NCT00310440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2020-03-12

Study results available
· View outcomes & findings →

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..

Conditions

  • Intervertebral Disk Degeneration

Interventions

DEVICE

P-15 Synthetic osteoconductive bone substitute

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

OTHER

Autologous bone

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

Sponsors & Collaborators

  • CeraPedics, Inc

    lead INDUSTRY

Principal Investigators

  • Michael Janssen, MD / DO · Spine Education Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2014-05-31
Completion
2019-05-23

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310440 on ClinicalTrials.gov