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.
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.
Bottom Line: 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.
"Prospective, Multicenter Clinical Study Comparing Axial Lumbar Interbody Fusion (AxiaLIF®) and Transforaminal Lumbar Interbody Fusion (TLIF) Spinal Procedures"
The purpose of this study is to compare two surgical options that fuse the spine: AxiaLIF® (axial lumbar interbody fusion) and TLIF (transforaminal lumbar interbody fusion). Both AxiaLIF® and TLIF have been cleared for use in the United States by the Food and Drug Administration (FDA) and will be used according to approved guidelines. This means that both AxiaLIF® and TLIF are already available to patients on the commercial market, and neither procedure is considered experimental. Read more about AxiaLIF® and TLIF.
If you are eligible and you decide to participate in this study, you will be randomized to receive an AxiaLIF® or a TLIF surgery. You will be in the study for about 24 months. There will be about 200 subjects from approximately 15 clinic sites in the United States in this study. Make an appointment at the Spine Center to determine if you are eligible to participate in this study. Refer to the consent form below for more on study subject responsibilities and compensation.
Dr. McCarthy routinely performs Endoscopic Rhizotomy in his practice for patients with facet-derived low back pain that has not resolved with conservative treatment. The purpose of this study is to evaluate improvement in low back pain and function after this procedure. Patients will complete short questionnaires at pre-operative and 3 post-operative office visits. Make an appointment at the Spine Center to determine if you are eligible for this procedure and this study.
Learn more about Endoscopic Rhizotomy.
“Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis”
Dr. McCarthy is participating in a Phase 4 multi-center prospective study of the Aspen device for use in PLF in patients with spondylolisthesis. The purpose of the study is to evaluate clinical outcomes as determined by Oswestry Disability Index (ODI) improvement, success of fusion, and other measures in patients undergoing the procedure. Patients will be followed for 24 months. Make an appointment at the Spine Center to determine if you are eligible to participate in this study. For more information, visit the current ClinicalTrials.gov study page here.
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