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CAUTION: For Investigation Use Only.

Why was the KineGraph Vertebral Motion Analyzer (VMA) invented?

If you are a back pain sufferer, you may have already had x-rays taken of your spine. X-rays assist your doctor in your diagnosis, but only to a point.

Your spinal column is intricate and complex with shock absorbing discs surrounded by a structural boney vertebral column that supports your body and protects your spinal cord and nerve roots. Motion within your spine is dynamic, working in concert with surrounding muscles and ligaments; each level of your spine has its own unique role while being a part of a much broader cascade of movement across your entire spinal column.

Since the 1940’s stationary x-rays, taken at various angles, has been the standard in assessing spine function. Doctors routinely require an x-ray of the end point of the forward (flexion), backward (extension), and side bending positions. For decades there have been fluoroscopy machines that take x-ray images in motion, so Ortho Kinematics recognized the potential benefit in using these video x-rays for spine diagnosis. Ortho Kinematics is committed to going through the process of determining if the KineGraph VMA will help in spine care decisions in the future.

What is the difference between x-rays and the KineGraph Vertebral Motion Analyzer (VMA)?

The best way to explain the differences is to see them for yourself. Below is an example of end-range (as far as patient could go) flexion (forward bending) and extension (backward bending) static x-rays, and then a video of what is achieved via the VMA. See for yourself.

Why is the KineGraph VMA in a clinical study, what does that mean?

Clinical trials are conducted according to federal regulations and are necessary to answer specific questions about the safety and/or effectiveness of, in this case, a new diagnostic tool. Ortho Kinematics is required to enroll a predetermined number of patients from numerous sites across the country. Information from hundreds of patients will be compiled and analyzed to assess how useful the diagnostic test results are to doctors. While the KineGraph VMA is going through the clinical trial process, it is important to issue the following statement: “Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE."

What about my privacy regarding my medical condition?

If you are eligible and agree to be in the study, data collected from your scans will automatically be assigned a number. Federal law mandates strict requirements to de-identify all patients that enroll, thus Ortho Kinematics will never know your name or identity and it will not be disclosed in any study or report. A third party scheduler that sets up your appoints will know only your name in order to schedule your appointments. But, in regards to your medical information, confidentiality will remain between you and your doctor.

How do I get into the clinical study?

There are a limited number of clinical sites currently established in several major U.S. cities. Refer to our site map (link to site map here) to see if there is a site established near you. Only your physician, if an official clinical investigator, can make the decision that you are a candidate for inclusion in the study.

Do I have to pay to be in the study? Do I get paid to be in the study?

There is no cost to you to be involved in the study and compensation will be provided for time and travel.

What will I experience if I am in the study,
what does the machine do?

If you are enrolled in the study, a trained technician will walk you through the entire process before taking any images. They will make sure you are completely comfortable with the entire process.

What we call the VMA is simply a machine that assists you in bending in a consistent manner. One version rests on a table and you lie on your sided as it passively moves your body in flexion and extension, in a slow, smooth, steady motion slightly forward, then backward. That’s it. Another version will do the same movement but with this version you are standing up. A trained technician will run you through a “test” motion so you are comfortable with the movement. The machine will not go farther than you have already gone in any direction in the “test” run, so it will not push you to a point that you will be uncomfortable. If for any reason though, you have a Stop Switch that gives you full control in ending the evaluation.

What risks are involved if I agree to be a part of the study?

Every clinical study has some inherent risks, and the KineGraph VMA technology and the process by which patients are tested should be a relatively short test with little risk. If you have concerns, please consult with your physician prior to participating in the study.

What time commitment is required to participate in the study?

It should take you approximately 20 minutes to fill out the forms and no more than one hour for the actual radiological appointment. Then, as a normal course of observation, it is up to your physician’s discretion regarding the need for you to have follow-up examinations at standard observational intervals of 6, 12, and 24 months.

How do I prepare for my KineGraph VMA appointment?

For clear images, it is required that all metal objects in and around your body or garments not be worn to the appointment, as they will interfere with radiographic imaging. Examples of items to avoid or remove are body piercing, underwire bras, undergarments with metal snaps, etc… For safety considerations around the machine, if you have long hair it should be put up out of the way.