In the past, those suffering from spinal stenosis were limited to the surgical treatment option of spinal fusion. Today, surgeons can implant a device to preserve natural motion, balance and stability in the lower back.
The coflex® implant study involves lumbar decompression followed by a coflex® interlaminar implant versus pedicle screw posterolateral fusion for treatment of degenerative stenosis. Kenneth A. Pettine, M.D. is the principal investigator for this FDA IDE study.
The study involves comparing the clinical results of treating lumbar stenosis with a decompression followed by either a pedicle screw fusion or the coflex® interlaminar implant. This is a 2-to-1 randomization with two patients receiving the coflex® implant for every one patient receiving the pedicle screw fusion procedure.
Lumbar stenosis is a common condition in which the nerves exiting the lumbar spine become compressed as we age, resulting in leg pain and back pain. Oftentimes, these symptoms are aggravated by standing and walking. This is usually caused by a hypertrophy of the facet joints and the area of the spine where the nerves exit out the foramen.
The coflex® interlaminar implant was developed in Germany and has been implanted in more than 70,000 people outside the U.S. It provides stabilization of the spine without eliminating motion. It results in a controlled and restricted motion. It off-loads forces from the facets and the posterior disc while still maintaining spinal balance. It does allow for flexion and some stabilization in rotation.
The results of this study are being collated among approximately 25 sites across the U.S. and will be reported to the FDA. Preliminary results from four FDA IDE sites are included in the following graphs and these results are extremely encouraging. The implant itself has a long history of use in human beings outside the United States. Kenneth A. Pettine, M.D., performed the first two-level coflex® implant in the U.S. in August 2007. This study is currently closed, having enrolled 345 patients.
More information on the coflex interlaminar implant.
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The ACADIA™ facet replacement system is a chrome cobalt pedicle screw-based replacement for the facet joints in the lumbar spine. The device is designed to allow complete decompression of the spinal cord and nerve roots while potentially allowing the spine to return to normal physiologic motion. A potential advantage to replacing the facet joints with the ACADIA™ device is avoiding a fusion procedure, which may cause a permanent loss of motion in the spine.
ACADIA™ is quite unique; no other implant reproduces the anatomic design of the normal facet joints. The ACADIA™ facet replacement comes in numerous sizes, which allows the spine surgeon to customize the implant to mimic the normal facet joint in the patient. It is attached to the bone through pedicle screws, which have been used extensively in hundreds of thousands of patients since the mid-1980s.
Kenneth A. Pettine, M.D., is a principal investigator for this FDA study, which is currently enrolling patients. If you are interested in participating, please call our research coordinator, Nic Rittenhouse, at 970.669.8881 ext. 229 or email her.
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