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Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion

NCT01018771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-05

No results posted yet for this study

Summary

This is a prospective randomised study.

Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion.

Secondary objectives: Assess clinical outcome measurements.

Conditions

  • Degenerative Disc Disease

Interventions

PROCEDURE

Actifuse ABX

bone graft to be used in posterolateral instrumented lumbar fusion

PROCEDURE

INFUSE, plus Mastergraft granules

bone graft to be used in posterolateral instrumented lumbar fusion

Sponsors & Collaborators

  • Apatech, Inc.

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Australia

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 NCT01018771 on ClinicalTrials.gov