Patients
FAQ
1. How do people respond to the Stabilimax® system?
If you are eligible, the clinical research study in which you have been asked to participate is being completed to validate the safety and effectiveness of this investigational device. As a result, it is not yet known what the response will be for each patient.
Applied Spine Technologies, Inc. has begun a multi-center, randomized, controlled clinical study to evaluate a potential new advance in the treatment of degenerative lumbar spinal stenosis.
2. Will I know before being implanted with Stabilimax whether it will help me?
No. As stated previously, the purpose of the clinical research study is to validate the effectiveness of the device.
3. This is a “randomized” study. What does that mean?
A randomized study is an objective way to assess the safety and effectiveness of a new device or treatment. In this randomized clinical research study, Stabilimax is being investigated in relation to the spinal fusion surgery, the current standard of care, which is the control procedure. A participant’s chance of getting either the Stabilimax device or spinal fusion surgery is, literally,
random. No participant will know in advance which procedure they will receive, nor can
they choose their procedure. However, in this clinical research study, two-thirds
of the participants will receive Stabilimax.
4. What are the requirements for participants?
Prior to the surgical procedure: all participants will undergo tests to make sure they qualify for the clinical research study. This is called "screening." Screening includes receiving bone imaging, filling out questionnaires, scoring symptoms
and reporting on use of any medication(s). Participants will also receive an x-ray, MRI, physical exam and neurological assessment.
During surgery: the surgeon will assess bone strength and anatomy before continuing with the trial procedure.
After the surgical procedure: participants will be seen for a minimum of five follow-up visits during the 24 months post-surgery. During an average visit, participants will fill out questionnaires, score their symptoms and report on their use of medications. They will also receive an x-ray, MRI, physical exam and neurological assessment.
5. Where will the procedure be done?
There are 20 sites across the U.S. in which trial procedures will be performed.
