Two Trials Initiated for Post Op Indications
December 15, 2011
Amp Orthopedics Expands Clinical Pipeline Initiating Two Trials For Post-Surgical Indications:
Knee Replacement and Rotator Cuff Repair
Seattle, WA – December 15, 2011 – Amp Orthopedics, a privately held medical device company, announced the initiation of two well-controlled clinical trials, one evaluating patients undergoing total knee replacement and a second in patients having arthroscopic rotator cuff repair surgery. The goal of these randomized, double-blinded, sham-controlled trials is to determine the safety and effectiveness of the company's non-thermal pulsed radio frequency (PRF) technology to reduce narcotic (opioid) use, decrease pain, and improve function and quality of life following these surgical procedures. Results of both trials are anticipated in 2012.
“Despite recent significant advances in orthopedic surgical techniques that enable meaningful improvements in the restoration of function and return to normal activity, our ability as physicians to manage pain has not kept pace. Patients remain in need of safer, more effective, and less invasive treatments to manage the pain and edema that often slow a patient's recovery, delay discharge and add unnecessary cost and resource consumption to the healthcare system,” said Jerry Engh, MD, Director of Knee Research, Anderson Orthopaedic Research Institute, Alexandria, VA and Principal Investigator for the Total Knee Arthroplasty trial. “Amp's PRF technology holds significant promise for broad utility in a range of orthopedic indications.”
Total Knee Arthroplasty (TKA) and Rotator Cuff (PARC) Trial Designs
“The orthopedic, arthroscopic, and sport medicine communities recognize the need for prospective, randomized-controlled trials in order to support the adoption of new technologies into clinical practice,” commented Felix "Buddy" H. Savoie, III, MD, Lee C. Schlesinger Professor of Orthopaedics and Chief of Sports Medicine, Tulane University School of Medicine, New Orleans, LA. “This study will generate the highest quality, Level I evidence of safety and efficacy, in order to evaluate the effectiveness of PRF treatment for post-surgical pain mitigation. In addition, our placebo-controlled study design represents a powerful research tool which will allow my co-investigators and me to answer the clinical question in a manner compelling to practicing orthopedic surgeons and related researchers.” Dr. Savoie is the Principal Investigator for the PARC trial.
Amp's PARC trial is a multi-center, prospective study designed to determine the effectiveness of Amp's non-thermal PRF technology on narcotic use, pain, and health-related quality of life post-arthroscopic rotator cuff repair. The trial will enroll 102 patients, randomized to receive active or sham devices for six weeks. The trial's primary endpoint is the mean daily narcotic consumption during Week 1. Secondary endpoints include narcotic consumption during Weeks 2 through 6, pain severity, patient-reported general health-related quality of life score (EQ-5D), and monitoring of adverse events.
The Amp TKA trial is a prospective, double blind, randomized clinical study to investigate the effectiveness of its PRF technology on reducing post-operative narcotic use and improving post-operative pain severity, knee edema, and joint range of motion in patients recovering from TKA. The single site trial will enroll 100 patients, randomized to either active or placebo (sham) treatment. The trial treatment period is four weeks, beginning post-surgically and continuing post-discharge. The trial's primary endpoint is the average daily morphine equivalent dose at 2 weeks post-surgery. Secondary endpoints include total opioid use (in-hospital and post-discharge), knee pain severity, knee joint circumference (a measure of swelling or edema), knee range of motion, concomitant medication requirements (including analgesics, anti-inflammatories and other non-opioid medications), and monitoring of adverse events.
“The initiation of two new clinical trials in post-surgical orthopedic indications, along with our recently announced osteoarthritis pain trial represents an exciting expansion of Amp's clinical pipeline and growing product portfolio,” said Eric Dremel, Amp Chief Executive Officer. “Both total knee arthroplasty and rotator cuff repair are large, underserved commercial markets in which there is a growing need for non-invasive pain management approaches that are free of the health risks associated with anti-inflammatory or potentially addictive narcotic pain medications. We are delighted to work with such respected clinical investigators in the orthopedics field to further elucidate the therapeutic potential of our PRF technology.”
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 osteoarthritis 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.
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: www.amportho.com.