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NCT01549366 · ClinicalTrials.gov registry record · NA

Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion

A NA study, sponsored by Zimmer Biomet.

Completed
Registry status
NA
Development phase
64
Enrollment target

NCT01549366 is a NA study that has completed, run by Zimmer Biomet. The registered enrollment target is 64 participants.

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The verdict

NCT01549366, a NA study, has completed, sponsored by Zimmer Biomet.

COMPLETED
Registry status
NA
Development phase
64 participants
Enrollment target

Study Summary

The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of fusion.

Interventions

  • DEVICE Aspen Spinous Process Fixation Device
  • DEVICE Pedicle Screws

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2012-02
Est. Completion 2016-01
Phase NA

Sponsor

Zimmer Biomet

115 total trials

What the Registry Record Tells You About NCT01549366

The ClinicalTrials.gov registry entry for NCT01549366 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 115 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Aspen Spinous Process Fixation Device is the first listed.

NCT01549366 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01549366 about?

NCT01549366 is a clinical study titled "Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion". The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to pedicle screw instrumentation in Os...

What is the current status of trial NCT01549366?

This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2012-02. Estimated completion is 2016-01.

What interventions are being tested in trial NCT01549366?

The interventions under investigation include: Aspen Spinous Process Fixation Device (DEVICE), Pedicle Screws (DEVICE).

Who is sponsoring clinical trial NCT01549366?

This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.