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What is the purpose of a clinical study?
The purpose of a clinical study (also called a “clinical trial” or “research trial”) is to examine treatment options for specific health conditions. Although there are many types of clinical trials, all must conform to 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. |
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What will I need to do if I take part in the ACADIA Facet Replacement Clinical Study?
If you choose to take part in the ACADIA Clinical Study, you will be asked to:
• Read and sign the Informed Consent form
•Undergo surgical treatment for your Lumbar Spinal Stenosis
• Schedule and attend follow-up visits
• Complete specific questionnaires and tests to document your progress
• Quickly report any problems to your physician
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How come some patients in this study will undergo the ACADIA Facet Replacement procedure while others will undergo a spinal fusion procedure?
This study is intended to compare two approaches for treating Lumbar Spinal Stenosis: Surgical Decompression with Facet Replacement (using the investigational ACADIA Facet Replacement System)
and Surgical Decompression with Spinal Fusion (a current standard of care for treating Lumbar Spinal Stenosis). As part of the study, 2 out of every 3 patients will receive the ACADIA Facet Replacement System, while 1 out of every 3 patients will receive standard spinal fusion. |
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What happens during my follow-up visits?
Following your treatment, you will be asked to visit your study doctor’s office a total of 5 times over a 2-year period. During these visits, your doctor will evaluate your progress. Depending on the specific visit, you may be asked to fill out questionnaires about your symptoms or use of medications, you may receive an x-ray, or you may receive a neurological exam. |
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What if I miss a follow-up visit?
If you can not make a follow-up appointment, please notify your physician’s office to reschedule as soon as possible. It is required that each of your follow-up visits is completed within a certain window of time. |
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Are there any costs involved 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. |
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Where is the ACADIA Clinical Study being conducted?
The ACADIA Clinical Study is being conducted at spine centers throughout the U.S. To see if the ACADIA Clinical Study is being offered in your area, please take a moment to visit the pre-screening questionnaire. The questionnaire will ask for your zip code and then search for ACADIA study locations in your area. |
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When will I know if I am eligible?
If you pass the initial pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent to the local ACADIA study location in your area. Your local site will then contact you to review your responses and help determine your eligibility. |
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How is my health information protected?
The Health Information Portability and Accountability act (HIPAA) of 1996 was developed by the U.S. Congress to protect the confidentiality of an individual’s personal medical information. It sets boundaries on the use and release of health records and establishes safeguards to protect the privacy of health information. The ACADIA Facet Replacement Study is in compliance with all HIPAA Regulations. |
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Who is the company responsible for the ACADIA Clinical Study?
The company sponsoring this study is Facet Solutions, Inc., headquartered in Hopkinton, MA. Facet Solutions, Inc. is a medical device company focused on commercializing facet replacement technology. |
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What if I have other questions about the ACADIA Clinical Study that are not addressed on this website?
To see if you might qualify for the ACADIA Clinical Study, and to be referred
to a spine center in your area, please take a moment to complete the
pre-screening questionnaire (you can also take the questionnaire over the phone by calling 1-877-788-3925. If you pass the pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent to the local ACADIA study location in your area. Your local site will then contact you to answer any additional questions you might have about the ACADIA Clinical Study. |
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