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Baxter: Actifuse SHAPE vs DBX in ACC

NCT02005081 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-09

No results posted yet for this study

Summary

The purpose of this single-center, prospective, randomized study is to determine the fusion rates along with the clinical outcomes of commercially available bone graft substitutes Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in patients experiencing cervical spondylotic myelopathy (CSM).

Conditions

  • Cervical Spine Degenerative Disease Nos
  • Cervical Spondylosis With Myelopathy

Interventions

DEVICE

Actifuse SHAPE

Actifuse Synthetic Bone Graft substitutes mixed with bone marrow aspirate in cervical spine fusion. Actifuse is a synthetic, porous, silicate-substituted hydroxyapatite and has shown that this maximizes a favorable bony response.

DEVICE

Autograft with Demineralized Bone Matrix

autograft mixed with demineralized bone matrix in cervical spine fusion.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Hazem Eltahawy, MD · Wayne State University, DMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-10-31

Countries

  • United States

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 NCT02005081 on ClinicalTrials.gov