NCT00534235View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

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

Lead Sponsor

Paradigm Spine
All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

Paradigm Spine

INDUSTRY