Status: This trial is now full.
UPDATE: FDA Approved!
Dr. Anthony Yeung, Principal Investigator in the study, along with investigators Dr. Christopher Yeung and Dr. Justin Field, participated in this clinical trial that led to this FDA approval. DISC, the only site in Arizona involved in this trial, was in the top 5 sites whose data was used for papers presented to national and international meetings authored by Josh Auerbach.
For more information, go to:
"COFLEX® INTERLAMINAR TECHNOLOGY RECEIVES FDA APPROVAL!" »
or Read on PubMed »
The Coflex® Dynamic Interspinous Stabilization Device Clinical Trial is designed to compare the safety and effectiveness of a new way to treat spinal stenosis. This trial is a multi-center, prospective, randomized controlled study that will evaluate the safety and effectiveness of lumbar laminotomy decompression augmented with the implantation of the coflex device as compared to the most common treatment of spinal stenosis; lumbar laminotomy decompression, augmented with pedicle screw fixation and fusion.
Spinal Stenosis is the narrowing of the spinal canal. Some common factors contributing to the development of spinal stenosis:
- The process of aging leads to degeneration in the spine that may create bony spurs and outgrowths on spinal vertebrae. These osteophytes can extend in the direction of the spinal canal and place pressure on neural elements.
- Stress and degeneration of the spinal ligaments over a lifetime may lead to thickening of these ligaments. The spinal canal can also be narrowed this way.
- As we age, changes in the stability of the spine cause the posterior joints (facet joints) to become loosened with stress. This stress on the facet joints can cause hypertrophy (overgrowth) of the joints and surrounding capsules, which in turn further narrows the spinal canal and can place pressure on central and exiting neural elements.
Symptoms of Spinal Stenosis
The most common symptoms of spinal stenosis are pain, weakness, tingling or numbness in the lower extremities experienced after walking or exercise. Patients commonly experience associated pain in the low back and buttocks. This pain can radiate down one or both legs. Often the pain shortens the stride, inhibiting walking or even immobilizing the patient. These symptoms are known as neurogenic claudication.
Many patients find their symptoms are worst when standing or walking, and find some relief from sitting, lying down or bending forward, all of which movements widen the spinal canal.
Up to twenty-five clinical sites will participate. Total enrollment of 460 or more patients is expected.
Patients will be randomized to receive either decompression and coflex for stabilization, or decompression and pedicle screw fixation and fusion for stabilization.
Patients will be followed at 6 weeks, 3 months, 6 months, 1 year, 2 years and annually up to 5 years.
Who qualifies to enroll in this trial?
Before any trial procedures can begin, anyone who participates in this study must properly sign and date the Informed Consent Form (ICF). Your doctor will explain to you the trial procedures, and the possible risks and benefits of your participation. As part of the informed consent process, your doctor will also explain to you what personal information of yours is to be collected, including medical records.
Although your doctor can explain the full details, here is a partial list of some of the criteria for participation in this study:
- 40-80 years old
- Appropriate candidate for surgery
- At least moderate lumbar stenosis
- No more than 2 levels should require surgery (those levels must be consecutive)
- No prior lumbar fusion
- No lumbar disc herniation requiring concurrent surgery
- No pregnancy or planned pregnancy
- Must have had at least 6 months prior care and failed non-operative treatment
Why is this Trial being conducted?
Over 25,000 people outside the U.S. have been implanted with the coflex® investigational device. An article in the professional journal Medical News Today reports on some of the positive early clinical results for the coflex,® investigational device. These results include:
- Of a group of 200 patients implanted with the coflex device in Damp, Germany, 86% reported relief in low back pain that allowed them to significantly increase their walking distance.
- Based on a 12-month follow-up with 46 patients (with an average age of 63) treated with the coflex device in Straubing and Bogen, Germany, results showed reduced post-operative disability and pain scores as compared with pre-operative scoress
At this time, the sponsor company, Paradigm Spine, LLC, has received approval by the US FDA to conduct this Clinical Trial in the US. The company is seeking approval to market the coflex device in the US after all regulatory requirements have been fulfilled.
To learn more about the coflex Study, please use: www.coflexspinestudy.com or contact Jennifer Camoriano, Research Coordinator at: 602-944-2900 ext. 124