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GRATIFY-1 Study


GRATIFY-1 STUDY
Genicular Radiofrequency Ablation (RFA) To Improve Function & Recovery After Surgery
coolief-knee-blueboxThe Ainsworth Institute of Pain Management is conducting a clinical trial on the use of Genicular Radiofrequency Ablation before knee surgery to reduce postoperative pain and improve recovery.  This study was created by our physicians at the Center for Clinical Studies and is made possible through a research grant from St. Jude Medical.
Chronic knee osteoarthritis (OA) is one the most common diseases of advanced age. Greater than 12% of the American population experiences pain and functional limitations from chronic knee OA[i] with 1 in 2 people predicted to developed symptomatic OA of the knee by 85 years of age.[ii] Even more remarkable is the prediction that by the year 2030, an estimated 67 million Americans ages 18 years and older are projected to have doctor-diagnosed arthritis.[iii] There are several treatments available for a painful, degenerated knee joint, such physical therapy, bracing, steroid injections, viscosupplementation, arthroscopic surgery and, ultimately – total joint replacement surgery.

Click Here to Read More About Arthritis

While total joint replacements are an established treatment method for knee OA, many are hesitant to undergo this surgery due to the long and arduous post-operative course of rehabilitation as well as the pain – as a result, there has been a substantial interest in developing alternative treatments which can either delay or even help avoid joint replacement surgery, altogether. Treatments such as platelet rich plasma and stem cell therapy, which are not covered under any insurance plan and require a large financial investment the patient, have entered the mainstream simply due to the promise of potentially prolonging the need for such a major surgery. This continued need eventually led to the discovery of Genicular Nerve Ablation as a treatment for pain from Knee OA – an effective modality AND covered by most insurances.
The premise of this procedure is to safely block the pain signals from the knee yet leaving the joint completely unmolested. The innervation of the knee is comprised of branches of femoral, saphenous, common peroneal, tibial and obturator nerves. Small, articular branches of these nerves, known as the genicular nerves, surround the knee and provide innervation to the joint.

Click Here to Read More About the Anatomy of the Knee

References


[1] Dillon CF, et al. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. November 2006; 33(11): 2271-2279.
[2] Arthritis Rheum 2008;59(9):1207–1213. Abstract External Web Site Icon [Data Source: 1999-2003 Johnston County Osteoarthritis Project data]
[3] Arthritis & Rheumatism 2006;54(1):226-229

Related Content

Genicular Nerve Ablation

Genicular Nerve Ablation is a treatment option for patients with knee pain who may be unwilling or unable to undergo surgery. In it, a sophisticated type of radio wave is applied to the genicular nerves surrounding the knee. Radiofrequency ablation of the knee can alleviate pain and potentially restore function. It is a minimally invasive and inexpensive option for to potentially avoid knee surgery altogether.

Radiofrequency Ablation (RFA)

A procedure that can be used to treat several different kinds of chronic pain throughout the body, though it is most commonly used to treat neck and back pain. In RFA, the doctor uses fluoroscopically guided needle to target the painful nerve, or pain generator. The nerve is then bombarded with radio waves, which effectively stuns it and ceases the pain. Using RFA, the physician can treat pain without a single incision; patients have reported the cessation of pain symptoms to last a year or more.

Can I Participate in this Study?

Must be between 21 and 85 years of age
A diagnosis of degenerative joint disease of the knee and scheduled for total knee arthroplasty
Positive response to geniculate nerve block (defined as greater than equal to 50% reduction in pain)
No history of rheumatoid arthritis, systemic inflammatory conditions, or any current use of a blood thinner
• Patient is on a stable medication regimen for pain (i.e. opioids, antidepressants, and anti-epileptics medications) for at least 6 weeks prior

Details of the Study
Patients who qualify for the study will be randomized to receive either Genicular RFA or a sham procedure. Patients will then proceed with their surgery as planned and follow up with our research staff up 12 months after the surgery.

CALL OUR OFFICE TODAY TO SEE IF YOU ARE A CANDIDATE FOR THIS STUDY

Study Enrollment Form
Official Protocol Name: Preoperative Radiofrequency Neural Ablation for the Management of Pain during Postoperative Rehabilitation After Total Knee Replacement

Call our office if you are interested in finding out more information on this study

Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis.  Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.