Spine centers in the U.S. are currently accepting new participants for Simplify™Trial.
If you are experiencing numbness, tingling or pain in your neck, shoulder or arm, these may be symptoms of cervical disc disease.
What is the cervical spine?
The cervical spine is made up of seven (7) vertebrae, separated by discs that cushion and stabilize the neck and allow it to move smoothly. All discs degenerate over time, which may cause symptoms such as radiating pain, numbness, tingling or weakness in your shoulders, arms and hands. These symptoms may have a major impact on your quality of life. If you experience these symptoms you should see your doctor.
What is cervical disc disease?
Cervical disc disease is neck or arm pain and/or a functional or neurological deficit with imaging confirmation of herniated disc, loss of disc height or bony growth. This may create pressure on the spinal cord or nerve roots and may occur over time or it can occur after an injury or trauma to the neck ( fig. 1 ).
How do you diagnose cervical disc disease?
Cervical disc disease is diagnosed through medical history, neurological exams and imaging tests (X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans) to visualize the spinal cord and determine the source of neck pain.
MRI is considered by leading spine specialists to be the ideal screening method for evaluation of cervical symptoms, and is preferred to CT because of its ablity to image soft tissue without exposing the patient to radiation. (Sundseth, J. Eur Spine J. 2013)
Do I need surgery?
If physical therapy, medications, or injections fail to provide relief, you may be referred to a spine surgeon for conventional anterior cervical discectomy and fusion (ACDF), or cervical artificial disc surgery.
ACDF involves removing the damaged disc, and using plates, screws and bone graft to fill in the space, creating a column of bone. While ACDF surgery is effective at eliminating pain, it also eliminates natural motion between vertebrae. Cervical artificial discs, by contrast, are designed to retain natural motion. Simplify Medical Website »
Simplify™ Disc is a cervical artificial disc designed with materials that work with MRI (fig. 2). to provide superior imaging (fig. 4) and eliminate CT scans
Surgical treatment with Simplify Disc is designed to eliminate the need for CT scans
Surgical treatment with Simplify Disc is designed to eliminate metal wear
Simplify Disc has the widest range of patient sizes
1. Linet, CA Cancer J. Clin 2012
Why should I consider Simplify Trial participation?
Surgical treatment with Simplify Disc is designed to alleviate neck, shoulder or arm pain caused by cervical disc disease and restore natural motion to your cervical spine. Simplify Disc may provide benefits that are NOT currently available with FDA-approved cervical artificial discs.
What are the Simplify Trial details?
Spine surgery centers in the U.S. are accepting new participants for the Simplify Trial. The study is for Simplify Disc, a non-metallic, MRI-compatible cervical artificial disc and an investigational device. Simplify Medical website »
Where is Simplify Trial being done? NOTE: Only patients within 150 miles of these sites are eligible.
What are the requirements of Simplify Trial?
If you are a qualified patient candidate and choose to join Simplify Trial, you will receive Simplify Disc and all study-related care from a team of spine specialists at one of the trial locations.
The pre-operative screening visit and follow up visits will include X-rays, neurological examination, and questionnaires.
Following your Simplify Disc procedure, you will meet with your study surgeon for a post-operative, 6 weeks, 3 months, 6 months, 12 months and 24 months visit.
After 12 months you will continue to be followed thereafter on an annual basis until follow- up is no longer required by the FDA.
These visits are an important part of the Simplify Trial, as they allow your surgeon to closely monitor your results. You will receive compensation following the completion of most of the study visits.
How do I qualify for Simplify Trial participation?
If you have been diagnosed with or believe you have cervical disc disease or have been told you require ACDF surgery (fusion), you may be interested in Simplify Trial.
To see if you might qualify for Simplify Trial, and to get connected directly with the local spine center in your area conducting the trial, you should take the pre-screening questionnaire.
How do I get pre-screening for Simplify Trial?
Click here to take an online questionnaire.
Taking the pre-screening questionnaire allows you to see if you qualify for Simplify Trial. The questionnaire may determine if you meet the key inclusion criteria for Simplify Trial.
What are the next steps?
If you meet the pre-screening criteria, you will be contacted within a few days by your local Simplify Trial center to provide you additional trial information and answer your questions.
Only your local Simplify Trial center can tell you if you are eligible.
Completing the pre-screening questionnaire does NOT obligate you to participate in Simplify Trial. Please consult your physician regarding your potential to participate in Simplify Trial in a center in your area. Simplify Medical website »
Please complete this pre-screening questionnaire to see if you qualify for Simplify Trial.
How did you first learn about Simplify Trial?
Please enter your zip code so that we can find the nearest Simplify Trial location.
If you qualify and choose to join Simplify Trial, would you be able to travel to this location for your disc procedure and 4-5 follow-up visits during the first year post-surgery and annually thereafter?
What is your age?
Do you currently experience pain, numbness, tingling or weakness in your neck, shoulder, or arm?
Is your pain ONLY in the back of your neck and is it your only problem?
Have you been diagnosed by a physician as having cervical disc disease (problems with the discs in your neck)?
Have you been diagnosed with osteoporosis?
Have you ever been told by a physician that you have 2 or more damaged discs in your neck or cervical spine that may require surgery?
Have you had any of the following? (Please check all that apply)
Have you ever had cervical spinal fusion surgery (neck)?
Do you have diabetes that requires you to take insulin on a routine basis?
Have you been diagnosed with rheumatoid arthritis, hepatitis B or C, or fibromyalgia?
Are you pregnant, or plan to become pregnant within the next two years (female only)?
Thank you for answering our questions. Your responses have met the preliminary criteria for the study. If you’re still interested, the next step is for your local Simplify Trial center to contact you directly. They can tell you more about the study and what is involved, and answer any questions you might have. By speaking with your local study site, you are not under any obligation to join the study. Only your local study site can determine whether or not you may be eligible to join the
If you would like your local study center to contact you, please provide the following information. Someone from your local study team will then contact you within the next several days.
Please note: your contact information will only be shared with your local study center so that they can follow-up with you directly to discuss the study. Your information is not used for any other purpose.
Thank you for answering our questions. Unfortunately, based on your responses you do not qualify to participate in the study. We are required to follow very specific screening guidelines to ensure that the study criteria are met. Thank you for your interest in the study and have a nice