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

NCT00401518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2020-09-10

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

Non-randomized ACADIA® Facet Replacement System

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

DEVICE

Randomized ACADIA® Facet Replacement System

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

DEVICE

Randomized Instrumented posterolateral fusion (PLF)

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

Sponsors & Collaborators

  • Globus Medical Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2017-08-31
Completion
2017-10-31

Countries

  • United States
  • Puerto Rico

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 NCT00401518 on ClinicalTrials.gov