Clinical trial

A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

NCT00401518 · Globus Medical Inc, Industry · Completed

Key facts

NCT number NCT00401518
Title A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Official title The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
Lead sponsor Globus Medical Inc, Industry
Status Completed
Study type Interventional
Conditions Lumbar Spinal Stenosis
Intervention type Device
Interventions Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, Randomized Instrumented posterolateral fusion (PLF)
Enrollment 390
Start date Oct 1, 2006
Primary completion Aug 1, 2017
Completion Oct 1, 2017
First posted Nov 20, 2006
Last update posted Sep 10, 2020
Countries Puerto Rico, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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