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Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion

NCT01013389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-05

No results posted yet for this study

Summary

The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion.

The secondary objective of this clinical trial is to assess clinical outcome measurements.

Conditions

  • Degenerative Disc Disease

Interventions

PROCEDURE

Actifuse ABX

bone substitute used for posterolateral instrumented lumbar fusion with interbody fusion

PROCEDURE

INFUSE, plus master granules (MGG)

bone substitute in posterolateral instrumented lumbar fusion with interbody fusion

Sponsors & Collaborators

  • Apatech, Inc.

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Huub Kreuwel, Ph.D · Director, Medical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Australia
  • Netherlands

Study Locations

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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 NCT01013389 on ClinicalTrials.gov