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Home > Research > Spinal Stenosis > Paradigm Spine Coflex™ Study

Spinal Stenosis

Paradigm Spine Coflex™ Study

We are looking for volunteers who have been diagnosed with low back pain associated with a problem called spinal stenosis at 1 or 2 levels in the spine that has not responded to non-surgical treatment. 

The Coflex™ medical device is in the new generation of dynamic stabilization implants designed to reduce nerve compression and create spinal stability while working to return your spine to a state that more closely resembles its normal physiology.   This study is currently enrolling patients to determine the safety and effectiveness of the Coflex™ dynamic stabilization implant as compared to pedicle screw fixation for spinal stenosis.

A partial list of the criteria is:

• You must be between 40 and 80 years of age,
• Have moderate to severe spinal stenosis in the lumbar area, have undergone at least six months of prior conservative care, including one epidural injection without adequate and sustained symptom relief,
• You must not have had a spinal fusion in the past.

This is a clinical trial looking for effectiveness and safety of the Coflex™ investigational device. An investigational device is one the U.S. Food and Drug Administration (FDA) has not determined to be safe and effective. The coflexTM procedure involves removing the problem bone and tissue pressing on spinal nerves, then implanting the study device through the lower back in the space between the affected vertebrae.  No bone will be placed between the vertebrae.  The Coflex™ is designed to stabilize the vertebra while potentially still allowing some motion in that part of the spine.  It is hoped that stabilizing the vertebra will decrease or eliminate the cause of pain.