Now Enrolling: ACADIA Facet Replacement System Study for Lumbar Spinal Stenosis

The ACADIA™ Facet Replacement System (AFRS) study is designed to compare two treatment options for lumbar spinal stenosis and is one of many clinical trials in which The Spine Institute is participating. This page is designed to provide more information as to what the study involves and who is eligible to participate. After learning about the study here, if you are interested in participating or would like to receive more information, please contact our research coordinator, Nic Rittenhouse, at 970.669.8881, ext. 229 or complete our contact form.

Pre-Procedure Evaluation

To be eligible for the ACADIA™ study, you must meet specific study criteria that are designed to find the best possible candidates for the study. During your pre-procedure evaluation, your doctor will review your medical history, perform a neurological exam, and take images of your lower spine called radiographs to determine the extent of your stenosis. You will also be asked to complete several questionnaires to help us determine the level of pain or discomfort your stenosis is causing you and how it’s affecting your quality of life.

The Procedure

If you qualify for the study and choose to participate, your doctor will treat your stenosis with one of two procedures: surgical decompression with facet replacement using the ACADIA™ Facet Replacement System or surgical decompression with spinal fusion, which is a current standard of care for treating lumbar spinal stenosis. The decision as to which treatment you will receive is decided at random. As part of the study, two out of every three patients will receive the ACADIA™ Facet Replacement System and one out of every three patients will receive spinal fusion.

Post-Procedure Follow-Up

After your procedure, you will need to attend follow-up visits at six weeks, three months, six months, twelve months, and twenty-four months so your doctor can document your progress.

Frequently Asked Questions

What is the purpose of a clinical study?

A clinical study (also called a clinical trial or a research trial) is to examine treatment options for specific health conditions.  Although there are many types of clinical trials, all must follow the strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical research studies.

Can I receive the ACADIA™ Facet Replacement System without joining the study?

No, the ACADIA™ Facet Replacement System is currently only available to patients through a clinical study.

Are there any costs involved with taking part in the ACADIA™ Clinical Study?

Any study-related tests, procedures, physician fees, or services that are not covered by your insurance will be provided to you at no cost. However, you will be responsible for your insurance co-pays.

How do I know if I’m right for the ACADIA™ study?

In addition to the medical information that your doctor will collect at your pre-procedure evaluation, there are criteria that will make you right for the study (inclusion criteria), and criteria that will automatically exclude you (exclusion criteria). Here is a brief list – the complete list may be found on the ACADIA™ study protocol summary on The Spine Institute website.

Inclusion criteria include:

• 21-85 years of age and skeletally mature
• Undergone at least six cumulative months of conservative treatment prior to surgery including any of the following:

- Medications
- NSAIDs
- Physical therapy
- Bracing
- Chiropractic manipulation
- Modified activities of daily living
- Epidural injections
- Facet block injections

• Persistent leg, thigh, and/or buttock symptoms, including pain, numbness, burning or tingling
• Willing and able to comply with post-operative and routinely scheduled clinical and radiographic evaluations
• Live in the immediate area of The Spine Institute (Loveland, Colorado) and have no plans to relocate to another geographic area before the completion of the study, or live outside the immediate area and are willing to comply with scheduled postoperative visits with a Spine Institute physician.

Exclusion criteria include:

• Previous surgical procedure at the operative or adjacent level, except for micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer
• Previous lumbar fusion or disc replacement procedure
• Osteoporosis
• Certain levels of spondylolisthesis or retrolithesis
• Scoliosis of the lumbar spine
• Discogenic back pain because of torn, herniated, inflamed or irritated disc or other cause that give you axial back pain from degenerative disc disease
• Spinal stenosis at more than three lumbar segments
• Acute trauma to the lumbar spine has occurred within the last 24 months
• Type I Diabetes
• Known allergy to cobalt chromium or titanium
• Pending litigation related to back pain or injury, or are currently receive Worker’s Compensation

These criteria will not automatically include you in or exclude you from in the ACADIA™ Clinical Study, they are merely to give you an idea of what’s involved. The complete list is available on the clinicaltrials.gov website.

For further questions on the study or to schedule a pre-procedure evaluation, please contact The Spine Institute Research Coordinator, Nic Rittenhouse, at 970.669.8881 ext. 229 or complete our contact form.

Spine Institute Home