Collaboration with Highmark Health VITAL Program Seeks to Determine Efficacy of More Immediate, Definitive and Less Expensive Assessment of Knee Injuries
Highmark Health, Allegheny Health Network (AHN), and Trice Medical announced today a collaboration to evaluate the effectiveness of a novel diagnostic arthroscopy device which enables physicians to conduct in-office visualization of knee joints. The partnership is supported by Highmark Health’s VITAL (Verification of Innovation by Testing, Analysis and Learning) Innovation Program.
The mi-eye 2™ from Trice Medical, which has been approved for use by the U.S. Food and Drug Administration (FDA), is a handheld arthroscope, consisting of a needle with an integrated camera and a light source designed for in-office tablet-based visualization and diagnosis of joint pain.
According to Trice Medical, there are approximately 20 million office visits annually for knee-related problems. Meniscal tears are among the most common injuries seen by orthopaedic surgeons with more than 700,000 meniscal surgeries performed annually in the United States. Osteoarthritis is the most common reason for knee replacement with more than four million Americans who have undergone total knee arthroplasty (TKA) and are living with implants.
“Traditionally with joint injuries the diagnostic process can span several weeks, often including an in-office physical exam, followed by an MRI, and then a follow-up consultation and surgery if needed,” said Sam Akhavan, MD, AHN orthopaedic surgeon and co-principle investigator of the study.
The study primarily intends to evaluate the effectiveness of the mi-eye 2 in providing a definitive diagnosis of meniscal tears, on the patient’s first visit, at a time and cost savings relative to the standard diagnostic process.
Additionally, the study will evaluate the device’s ability to aid in surgical planning, particularly for patients in need of joint replacement who could be candidates for partial knee replacement (uni-compartmental arthroplasty or UKA). Patients who undergo UKA usually spend less time in the hospital and return to normal activities more quickly than they would with TKA.
After numbing a patient’s knee, the surgeon inserts the 0.09-inch mi-eye 2 needle containing a wide-angle camera. With the device connected to the Trice tablet, video from the camera shows a 120-degree view of the interior of the joint. The precise view enables physicians to spot tears, as well as examine all three compartments of the knee to determine if osteoarthritis is limited to a single compartment.
Use of the mi-eye 2 could eliminate the need for other costly diagnostic modalities such as the MRI which, according to Trice Medical, is often inconclusive or can result in false readings. Further, not every patient is a candidate for MRI.
“Inconclusive or false readings can significantly lengthen the time from diagnosis to recovery. When we can be more efficient and precise in our operations, it means that our patients experience quicker and better outcomes so that they can get back to their daily lives,” said Timothy Sauber, MD, AHN orthopaedic surgeon and co-principal investigator of the study.
Other study participants include orthopaedic surgeons Patrick J. DeMeo, MD, Chair of the AHN Orthopaedic Institute, Michael Levine, MD, Darren Frank, MD, Brain Mosier, MD, Dennis Phillips, MD, Gregory Purnell, MD, Robert Schilken, MD, Scott Schweizer, MD, and Michael Seel, MD.
Through the Highmark Health VITAL program, payers are able to understand the full impact of new technologies on their members without changing insurance medical policy prematurely. Additionally, providers gain early access to novel technologies and a first-hand understanding of their impact on patients. In this way, technology vendors have the opportunity to prove the benefits of their new innovations to patients, providers and payers.
“VITAL’s mission is to leverage Highmark Health’s position as one of the largest integrated health care delivery and financing systems in the nation in order to accelerate the pace with which novel technologies and services are made available to the public,” stated David Holmberg, President and CEO, Highmark Health. “Our members and patients will be afforded access to safe new technologies that increase the quality of care and create positive patient outcomes without undue financial burden.”