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Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

NCT00534235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2020-02-06

Study results available
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Summary

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Conditions

  • Spinal Stenosis

Interventions

PROCEDURE

Decompression

Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

DEVICE

Posterolateral Fusion and Implantation of Pedicle Screws

DEVICE

Implantation of coflex Interlaminar Technology

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Paradigm Spine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

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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 NCT00534235 on ClinicalTrials.gov