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Clinical Trials

Dr. Kenneth Pettine in Clinical Trial Spine SurgeryThe foundation of The Spine Institute is research. At the core of that research is our extensive participation in numerous clinical trials for the scientific advancement of cervical and lumbar treatments.

Technology is changing rapidly, and while there are a number of devices in various stages of U.S. Food and Drug Administration (FDA) approval, there are also investigational devices that are gaining full FDA approval on a regular basis. The staff at The Spine Institute will help you understand the current standing of all devices and select the right procedure for your condition.

The Spine Institute is now enrolling candidates for a variety of clinical research trials to examine alternatives to lumbar and cervical spine fusion, including lumbar and cervical artificial disc replacement, and treatments for lumbar stenosis. These trials are a part of an FDA application to gain approval for a number of devices and procedures. Some of these surgical procedures have been performed in Europe for over a decade and are now being subjected to scientific analysis in the United States. You may research all clinical trials at www.clinicaltrials.gov.

The clinical trials are designed to prove the safety and efficacy of devices for treating degenerative disc disease (DDD) and other conditions that are currently surgically treated with a spinal fusion. Each trial has its own requirements. If you are interested in participating, please call our research coordinator, Kira Sniff  Clinical Research Coordinator, (970)-669-8881 x 229 KSniff@rmaortho.com

NOW ENROLLING: Glyder Facet Restoration Device Trial

The Glyder Facet Restoration Device is a novel investigational technology intended to provide relief from lumbar facet joint pain by restoring facet joint function and preserving native anatomy. The Glyder device is comprised of two wafers which are implanted into the facet joint. The outer surface of the wafers are textured to provide fixation to the cartilage of the joint.  The inner surface of the wafers are smooth and allow for an even gliding motion of the wafers across each other. The Glyder device is designed to provide the same motion characteristics as a natural facet joint.

The Glyder device is implanted using a minimally invasive technique and can be performed as an outpatient procedure. Participants with single level facet pain will be enrolled in this research study to evaluate the safety of the Glyder Device.

If you are interested in participating please click here

Cervical: M6-C Overview

The M6 artificial cervical disc offers an innovative option for artificial cervical disc replacement because of its unique design which is based on a natural disc’s qualities. Engineered to replicate your own disc, the M6 is the only artificial disc that incorporates an artificial nucleus (made from polycarbonate urethane) and a woven fiber annulus (made from polyethylene). The M6 artificial nucleus and annulus are designed to provide the same motion characteristics of a natural disc. Together, the M6’s artificial nucleus and annulus provide compressive capabilities along with a controlled range of natural motion in all 6 degrees of freedom along each vertebra. This “natural” motion is designed to provide the freedom to move your neck naturally. The M6 has two titanium outer plates with keels for anchoring the disc into the bone of the vertebral body. These outer plates are coated with a titanium plasma spray that promotes bone growth into the metal plates, providing long term fixation and stability of the disc in the bone.

Artificial Disc Components

Artificial Nucleus

•Viscoelastic polymer designed to simulate native nucleus

•Allows physiologic axial compression

•Retained between endplates & fiber annulus matrix

•Designed to enable physiologic Center Of Rotation

Artificial Annulus

•Ultra High Molecular Polyethylene (UHWMPE) fiber material

•Intended to simulate native annulus & its performance

•Designed to provide controlled physiologic motion in all planes and axes

•Robust fiber matrix with multiple layers similar to native annulus

Sheath

•Designed to minimize tissue in-growth & debris migration

•Allows for full range of motion

Fixation

•Titanium endplates with tri-keel design

•Titanium Plasma Spray (TPS) coated endplate

•Low profile keel height (2mm)

 

Interested in a Clinical Trial? Contact us below..


For Adult Stem Cell trial or information click here:

http://www.orthopedicstemcellinstitute.com/index.php?cID=238

All other clinical trials fill out the form below.

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