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NCT00401518 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Globus Medical.

Completed
Registry status
NA
Development phase
390
Enrollment target

NCT00401518: Completed NA study, sponsored by Globus Medical.

NCT00401518 is a NA study that has completed, run by Globus Medical. The registered enrollment target is 390 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00401518, a NA study, has completed, sponsored by Globus Medical.

COMPLETED
Registry status
NA
Development phase
390 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

Primary Outcome

Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)

Interventions

  • DEVICE Non-randomized ACADIA® Facet Replacement System
  • DEVICE Randomized ACADIA® Facet Replacement System
  • DEVICE Randomized Instrumented posterolateral fusion (PLF)

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2006-10
Est. Completion 2017-10
Phase NA
Globus Medical

10 total trials

What the finished NCT00401518 record still lists

NCT00401518 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 3 interventions - of which Non-randomized ACADIA® Facet Replacement System is the first listed.

NCT00401518 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00401518 about?

NCT00401518 is a clinical study titled "A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis". The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a ...

What is the current status of trial NCT00401518?

This trial is currently completed. It is a NA study. The enrollment target is 390 participants. The study started on 2006-10. Estimated completion is 2017-10.

What interventions are being tested in trial NCT00401518?

The interventions under investigation include: Non-randomized ACADIA® Facet Replacement System (DEVICE), Randomized ACADIA® Facet Replacement System (DEVICE), Randomized Instrumented posterolateral fusion (PLF) (DEVICE).

Who is sponsoring clinical trial NCT00401518?

This trial is sponsored by Globus Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00401518's enrollment target sits among peer trials

390 269th of 2000 higher than 1,731 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00401518, the US trial registry maintained by the National Library of Medicine. NCT00401518 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.