(Seattle, WA) -- Amp Orthopedics, a privately held medical device company, announced the initiation of a clinical trial in adults with mild-to-moderate knee osteoarthritis (OA) to determine the safety and effectiveness of the company’s non-thermal pulsed radio frequency (PRF) technology to ameliorate pain. The OARS trial is a randomized, sham-controlled, double-blind study of 150 patients utilizing standardized pain indices to measure changes in pain scores and compare pain reduction and duration of clinical benefit between the treated and control groups. The trial utilizes an innovative, Internet-based direct-to-patient recruitment methodology. Results from the trial are anticipated in 2012, and could become the basis for market clearance of the Amp device in the OA pain reduction indication.
“Safer, more effective, noninvasive treatments for OA pain are urgently needed, especially given the increase in incidence and prevalence of this disease in a rapidly growing aging population accustomed to maintaining an active lifestyle,” said Ken Zaslav, MD, Director of Cartilage Restoration Center, Advanced Orthopedic Centers, Richmond, VA, and Clinical Professor of Orthopedic Surgery, Virginia Commonwealth University. “A treatment that can provide clinically meaningful improvements in OA pain as well as improve knee function and quality of life, while reducing dependence on oral and injectable medications, would be welcomed both by patients as well as physicians.”
“The initiation of our clinical trial in OA pain is a major milestone for Amp,” said Eric Dremel, Amp Chief Executive Officer. “This well-controlled trial was designed specifically to allow for a direct comparison between PRF treatment and findings from other placebo-controlled trials of intra-articular corticosteroid and hyaluronic acid injections for knee OA symptoms. Our PRF treatment is designed for patient safety, comfort, control and ease of use. We are hopeful that this trial will demonstrate that PRF treatment can offer an effective pain reduction alternative to more invasive procedures. We are confident that the Amp technology has broad therapeutic and commercial potential in a wide range of orthopedic indications, and look forward to broadening our pipeline with additional PRF based products in the near future.”
The OARS Study Design
The objective of the OARS study is to determine the effectiveness of PRF treatment with the Amp technology for amelioration of knee pain in patients with mild-to-moderate OA. A secondary objective is to determine the duration of clinical benefit following discontinuation of treatment.
The 150-patient study will take approximately 12 months to complete, with a 6-month enrollment period, 1-week run-in period and an 8 to 26-week treatment period. The primary endpoint of the trial is a comparison of changes in current knee pain severity at 4 weeks over baseline. A between-group difference of at least 25 percentage points will be considered clinically significant. Secondary endpoints include measures of knee pain severity, quality of life based on patient assessment instruments and reduction in use of concomitant pain medications and modalities.
The study is being conducted by Mytrus, Inc., a San Francisco-based clinical technology and services company utilizing a novel, Internet-based, direct-to-patient recruitment methodology. The Mytrus approach uses an array of online social media and data management tools, and enables patients to safely participate in clinical trials from their own homes, thereby enhancing patient accessibility and convenience as well as improving trial cost-effectiveness. The Mytrus methodology complies with all FDA-required clinical trial practices and regulations, including informed consent. Amp believes that the patient-focused Mytrus approach can be particularly effective for this trial in accelerating and streamlining recruitment and ensuring compliance and retention.
Patients interested in screening for the study can start here: http://kneepain.mytrus.com/home
“The Amp OA pain trial is well-suited for a direct-to-patient clinical recruitment methodology,” said Nancy Lane, MD, Endowed Professor of Aging, Medicine and Rheumatology and Director of the Musculoskeletal Diseases of Aging Research Group at the University of California, Davis Medical School, Sacramento, CA. “Unlike traditional trials, patients can more easily participate and sponsors can save considerable costs in setting up and managing multiple brick and mortar study sites. Patients are routinely using the Internet to research and manage their medical conditions, as well as using convenient devices, including mobile phones, iPads and other web-enabled devices that can connect the patient to medical staff without requiring a site visit. This approach also leverages multi-media and online learning tools to bring patients a much better informed consent process. It may have the added benefit of providing better safety data. Because patients need not wait several weeks for the next visit to report issues, we can potentially get more accurate day-to-day details of their adverse events.”
Amp PRF Technology
The Amp technology utilizes a noninvasive, PRF signal which induces an electrical field to create a specific biological effect in tissue by increasing the binding kinetics of intracellular calcium to calmodulin (a first-order signaling molecule), which accelerates calmodulin-dependent biochemical cascades that are involved in tissue repair and regeneration. Electromagnetic field therapy has successfully been utilized for treatment of delayed-union fractures, chronic wounds, and postoperative pain and edema, as well as for the management of knee OA symptoms.
The Amp PRF technology received U.S. Food and Drug Administration 510(k) clearance for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue in December 2008. It was also granted a CE Mark for the promotion of wound healing, pain reduction, and treatment of post-operative edema in 2007. The study device consists of a signal generator (power supply), a therapy applicator, and a lightweight coil placed over the area to be treated. The easy-to-use device is patient-controlled, and designed to target only the injured tissue. The patented technology has been shown to be safe, with no associated side effects, chance of overdose or negative interactions with other treatments.
Osteoarthritis (OA) is an irreversible joint disease characterized by progressive loss of articular cartilage resulting in crepitus, pain, and joint dysfunction. OA most commonly affects the knee, with the hip and hands also frequently involved. OA affects 27 million adults in the United States, and the leading cause of disability in middle-aged and older adults and is the 6th leading cause of non-fatal burden worldwide. Given the aging of the population and the increasing rates of obesity, the burden of OA is expected to increase.
Despite the numerous treatments that are available for management of knee OA symptoms, no known therapy can alter the natural history of this disease. Symptom management includes: life-style changes; pharmaceutical interventions, such as non-steroidal anti-inflammatory (NSAID) and/or analgesic medications, including opioids which carry the risk of dependence; and pain mitigation procedures, such as intra-articular hyaluronic acid and/or steroid injections, arthroscopic lavage and debridement. These interventions can offer only short-term pain relief and carry the risk of serious side effects, underscoring the clinical need for novel noninvasive treatments with acceptable safety and effectiveness profiles.
Amp Orthopedics develops innovative, noninvasive products for the treatment of post-operative pain and edema in orthopedic indications. These products use a non-thermal pulsed radio frequency (PRF) technology that works in harmony with the body’s natural healing pathways to accelerate surgical recovery, reducing the need for narcotic pain and anti-inflammatory medications. Amp Orthopedics is currently conducting clinical trials in a variety of post-surgical settings and orthopedic diseases with the goal of improving treatment outcomes by reducing patient recovery and rehabilitation times while lowering healthcare costs. Amp is headquartered in Seattle, Washington, and is a subsidiary of Ivivi Health Sciences, a San Francisco based medical technology firm pioneering development of non-pharmacologic regenerative technologies. For more information, please visit the company’s website at http://www.amportho.com.
Founded in 2009, Mytrus is a privately held e-clinical technology company specializing in patient-centered electronic informed consent and data collection tools. After receiving the first FDA approvals for remote electronic consent and virtual data collection, Mytrus has gone on to develop new technologies for patients including ePRO and EDC tools usable from home and mobile devices, bio-sample consent tracking technology, site training and e-learning applications, and patient home dashboards for tracking clinical study progress and data. Mytrus also holds an exclusive patent for conducting virtual clinical trials in the US. Mytrus investors include BioClinica and inVentiv Health.