SEATTLE–(BUSINESS
WIRE)–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 companys 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.
A short video animation that describes the trial is
available here: http://www.youtube.com/watch?v=7iZGTP8NXoI
Patients interested in screening for the study can start
here: 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.
About Osteoarthritis
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.
About Amp
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 bodys 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 companys
website at: www.amportho.com.
About Mytrus
Founded in 2009, Mytrus is a San Francisco-based clinical technology and
services company built on the idea that modern technologies can enable people
to safely participate in clinical trials from the convenience of their own
home, thereby improving accessibility, convenience and compliance, as well as
cutting costs. Learn more about Mytrus at www.mytrus.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
