Clinical Trials at The Spine Center


 

Dr. McCarthy and the Spine Center team are dedicated to the discovery of new ways to diagnose and treat spinal injuries and disorders. The Spine Center team is engaged in clinical studies testing the effectiveness and safety of new devices and procedures in addition to studies that seek to expand the scientific and medical knowledge of existing procedures. Patients at the Spine Center have the opportunity to contribute to our research process by participating in one of our clinical trials. Please see below for more information on our currently available studies. Forms in this section require Adobe Reader.

Frequently asked questions about Clinical Research

What is a clinical research study?

Also called a clinical trial, a clinical research study is a scientific study of a medical treatment.  Research studies can evaluate new medical treatments, such as new drugs or procedures, or they can be used to learn more about the effectiveness of existing treatments. Data is collected before, during and after treatment to evaluate patients’ experiences and results. Once this data is analyzed, it can be published and shared with the clinical community. Clinical research results are very important for guiding and advancing clinical care. For studies involving investigational treatments, the results are used to gain FDA approval and ultimately reimbursement from insurance companies. For studies involving existing treatments, the results help guide physicians’ recommendations to patients and, with enough studies, establish standard of care treatments.

What types of clinical research studies are being conducted at the Spine Center?

Some of the studies we are conducting at the Spine Center are sponsored, multi-center, post-market device studies. This means we are evaluating surgical devices that are FDA approved and used by surgeons throughout the US. One type of post-market study seeks to determine if the device being studied is comparable or better than a similar device and surgical procedure. Patients in this type of study will be randomized to receive one of two comparable surgical devices. In another type of post-market study, all patients receive the same surgery. These studies evaluate efficacy based on patient improvement only. Both types of studies are used to advance the clinical knowledge of existing spine surgeries.

We are also involved in some in-house research. In-house studies are not sponsored; they are conducted to evaluate patient outcomes after surgery or other treatment at the Spine Center. These studies provide us with real results and statistics from our patient population that can be used in clinical decision making.

All studies conducted at the Spine Center are approved by the Western Institutional Review Board. This is a central IRB that reviews and monitors research studies. They provide guidelines for research sites to follow and ensure the protection of all research participants.

What is required of a patient in a research study?

Before a patient can be enrolled in a research study, he/she must sign an Informed Consent. This is a study specific consent form that the research staff will review with you. The Consent form is a great resource with patient oriented details about the study and all study procedures.

After a patient has consented to participate in a study, he/she will be asked to attend pre-operative and post-operative office visits (similar to standard care), get x-rays and/or MRIs, and fill out questionnaires about pain and function.  All sponsored studies offer compensation for patients fully participating in study visits. Our current studies offer up to $600 if you complete all the study visits. The sponsor company will also pay for all study specific tests or treatments that are not covered by your insurance company.

Why should I participate?

In addition to financial compensation for study visits, patients involved in a research study at the Spine Center receive the same support, care and the same surgical options that they would outside of the study. The study staff is an added resource; we are available to address any questions or concerns and coordinate all study activities. We carefully monitor research participants before and after surgery. Would you like to contribute to advancing treatments for spine care? Learn more about the current research studies at the Spine Center below.

 

Clinical Trials

BMAC Disc Study

If you suffer from degenerative disc disease (DDD) of the lumbar spine, the BMAC Disc Study may help.

Introducing the BMAC Disc Study – a single injection of Bone Marrow Aspirate Concentrate (BMAC) into the degenerative disc. BMAC contains growth factors and stem cells that may promote healing in your damaged disc. To see if you may qualify for this study, talk to your doctor.

We invite those 18 to 60 years old with single-level degenerative disc disease to see if they may qualify for the BMAC Disc Study. The purpose of this clinical research study is to evaluate the safety and effectiveness of a single BMAC injection for painful, single-level DDD of the lumbar spine.

You may be eligible to participate if you:

  • Are between 18 and 60 years old
  • Have been diagnosed with single level DDD of the lumbar spine.
  • Are willing and able to actively participate in a strict rehabilitation protocol and follow-up program

There are additional eligibility requirements that the study doctor can explain to you.

Our Locations

Choose your preferred location