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Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)

NCT01016314 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-23

No results posted yet for this study

Summary

This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

Aspen Spinous Process System

Aspen Spinous Process System is an interspinous process fixation device

DEVICE

Pedicle Screw Fixation

Pedicle Screws are used for the fixation of the spine

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Kee Kim, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT01016314 on ClinicalTrials.gov