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Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

NCT00637312 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-03-27

Study results available
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Summary

The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

Cervical Artificial Disc (Advent™ Cervical Disc)

Advent™ Cervical Disc

DEVICE

Hallmark™ Anterior Cervical Plate System

Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Scott L Blumenthal, M.D. · Texas Back Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-07-31
Completion
2013-02-28

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 NCT00637312 on ClinicalTrials.gov