CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 390 enrolled
Drug / intervention
Non-randomized ACADIA® Facet Replacement System +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00401518
NCT00401518N/ACompleted
CompareCT.gov

The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System

Globus Medical Inc·interventional·Posted Nov 20, 2006·Updated Sep 10, 2020

In Brief

A clinical study evaluating Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, and 1 other intervention for Lumbar Spinal Stenosis. Completed, enrolled 390 participants across 29 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis
CountriesPuerto Rico, United States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 19.6 years ago

Interventions

Non-randomized ACADIA® Facet Replacement Systemdevice

Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Randomized ACADIA® Facet Replacement Systemdevice

Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Randomized Instrumented posterolateral fusion (PLF)device

Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis