Rush University: Pain, Function Superior Using PRP over HA
Rush University researchers have recently un-blinded their results from a double-blind prospective randomized controlled trial comparing clinical outcomes and intra-articular biology in patients injected with leukocyte poor platelet-rich plasma (PRP) to those injected with hyaluronic acid (HA) for the treatment of knee arthritis. Brian Cole, M.D., professor in the Departments of Orthopaedic Surgery and Anatomy & Cell Biology at Rush University Medical Center, told OTW, “There has been a great deal of discussion surrounding the idea that platelet-rich plasma PRP is a biologic alternative to HA. Some think that it may cause changes in the intra-articular biologic milieu and thus mitigate the symptoms of osteoarthritis (OA). In our study, a double-blind prospective clinical trial, we randomized 111 patients into either the HA or PRP cohort. We found statistically significant improvements in pain and function at six months in those patients who received PRP as well as HA, with PRP demonstrating superiority for some outcome measures at six months. It was also interesting to note that some patients who initially failed to respond to HA injections administered prior to initiating the study actually responded favorably to PRP in the study.”
“Our study followed many of the existing requirements provided in the guidance document from the FDA that describes the basic tenants of methodology and outcomes when comparing two treatments in patients with osteoarthritis. Each patient underwent a blood draw so they did not know which arm of treatment they were assigned to, were blinded as to the nature of their injection and did not receive any insurance charges or explanations of benefits that would otherwise alert them as to the treatment received. It’s important to note that whoever got PRP also underwent a CBC [complete blood count] to quantitate the platelets in the PRP. We also did a unique biologic assay, an ELISA analysis of the synovial fluid, something that has not been done to date for both patient groups. This allowed us to understand the characteristics of the biology of the joint. We saw that those who received PRP had a significant improvement in the overall biologic milieu in the joint.”
“At this point we are still going through the data, and will be submitting this work for presentation at several upcoming meetings. The biggest challenge is that payers will look at this and ask, ‘Is there FDA biologic labeling?’ And, in absence of that, payers often challenge it. Going forward we may include a saline control to get this properly labeled for OA. Hopefully we will make enough progress in order to make a difference with payers…patients with OA really need more options that are safe and cost-effective.”
Dr. Cole’s co-authors on this study were Dr. Lisa Fortier, Ph.D., D.V.M., Vasili Karas, M.D., M.S.; David B. Merkow, B.A.; Kristen Hussey, B.S.; Angela Stuckey, B.S.; Nikhil Verma, M.D.; Bernard Bach Jr., M.D.; Bryan Forsythe, M.D.
Matt Provencher, M.D. Talks Comprehensive Care, New Role at Mass General
How to take something terrific and make it even better? That is the challenge facing the new head of sports medicine at Massachusetts General Hospital. But Matt Provencher, M.D., the medical director for the New England Patriots and a visiting professor at Harvard Medical School, has a plan. He tells OTW, “In considering the future of our program I turn toward trends in the field of sports medicine. It is becoming clear to my colleagues and I that people are athletes for life, whether your pursuits are a professional, occasional, or collegiate in nature. We have an emerging young, healthy population that wants to stay that way…and we must consider treatment concepts that do not involve surgery. I can’t think of a better word than ‘comprehensive’ when it comes to the future of sports medicine. We will increasingly see a team care approach that will take into account things such as core strengthening, better nutrition, less inflammatory food, adrenal access disorders, etc. Thus far, we have not done a great job with looking at these and other nonoperative, often nuanced, issues.”
“Take, for example, caring for a sprained ankle. If you focus solely on the ankle then you miss an opportunity to take ‘the high road’ of care. What exactly is wrong with this ankle? Is there something going on in the lower extremity? Is it a kinetic chain problem? A neurocognitive or proprioceptive issue? Is there muscle imbalance? It is vital to be able to consider these details. The challenge, however, is finding a way to provide episodic but longitudinal care and have payers recognize why we are having patients see all these experts.”
“Given that payers need to become more educated about injury prevention at some point we will be bringing a number of insurance representatives in for seminars on this topic. They must understand the value that these patients get from not only the healing treatment but also the preventative care the insurers are covering. For example, if you have a teenage female with a torn ACL [anterior cruciate ligament], we know that she is at a higher risk of tearing her other ACL. The payers need to know that preventing such an occurrence would save them tens of thousands of dollars.”
Dr. Provencher, a retired Navy Commander who is in charge of medical care of the Navy Seals, added, “Our goal is to be the comprehensive sports medicine center around…one that has a laser focus on the ultimate needs of the athlete at any level. We are continuing to strengthen relationships with neurology, physical medicine, and rehabilitation. In addition, we are now beginning to do community outreach for younger athletes in order to give them top notch care. We will also continue to strengthen our concussion clinic, work that is enhanced by the recent award of a $10 million NFL grant.”
Asked what he learned from his years in the military, Dr. Provencher noted, “It was in the Navy that my team building skills were honed. I learned the importance of crafting a vision, exhibiting fairness, ensuring transparency and treating people with the utmost respect. In the military you learn to rely on one another, and that everyone plays a role. It is this mentality that stays with me and will influence everything I do here at Mass General.”
Columbine-Tested Doctor Has Advice for Orthopedic Colleagues
There is no room for ad libbing in a mass casualty event, says Christopher Colwell, M.D., medical director of the Denver Paramedic Division and Denver Fire Department and the director of the Department of Emergency Medicine at Denver Health. Dr. Colwell, who was called upon during the Columbine tragedy, the Aurora theater shooting, and other mass casualty events, believes that orthopedic surgeons have a vital role in these events. He tells OTW, “The most important message I have for my orthopedic colleagues is that you must be prepared in advance for something of this nature and magnitude. When such a tragedy strikes that is not the time to ‘figure it out.’ If your hospital does not have an adequate disaster plan with regular drills that involve all of you then you should initiate improvements in the system.”
“Disaster planning is a team effort and should at no point become a turf issue. You must communicate early and discuss who has what role. In a traumatic event such as a mass shooting or explosion there are usually orthopedic injuries that must be addressed. There must be a structured approach to their management, however, and recognition that the first injuries seen may not be the injuries most urgently in need of intervention. As this is not something that is seen every day it requires a focus on team management, working with others to determine which patients have the greatest need for limited resources, including operative management.”
Asked what he learned from the Columbine experience, Dr. Colwell stated, “Our goal was to empty the emergency department…communication and getting organized at the scene were also vital. The early radio announcements indicated that help was needed at the scene, but in fact there were plenty of providers already there…the problem became that so many medical professionals arrived that a number of them actually got in the way. Well-intentioned providers showed up and didn’t know anyone and didn’t understand our system or know their way around. This chaos occurred in the ED as well and became a real problem when it was so crowded there that we couldn’t find the key people we needed. When this happens you have essentially transferred the disaster from the scene to the emergency department! A clear system of identification was needed so we were able to clearly recognize the senior decision maker for orthopedic surgery as well as other specialties.
“In many cases we like to set up a triage and establish groups of red, yellow, green at the scene that will be transported to the ED in the order of need. Then at the ED the most experienced surgeons and emergency physicians will be making the decisions as to who gets priority for CT scan, the OR, and other limited resources. The best scenario is to have a couple of orthopedic surgeons in the OR, with the most experienced orthopedic surgeon in the triage area working with the trauma surgeon and emergency physician to prioritize patient care. And it is important to empty the ED in order to address the needs of the mass casualty victims coming in and this may require creative methods such as moving current ED patients to outpatient clinics or other less acute areas of the hospital.”
“I understand that orthopedic surgeons want to be in the middle of the action and be the decision makers. As physicians we are pulled to that role, but believe me, too much of that thinking can cause real problems. After Columbine we began setting up a command system with an incident commander. Responsibilities of the incident commander can include addressing issues like making sure the cafeteria is open in the middle of the night, or resources in short supply are obtained, so it would rarely make any sense to have a physician in this role. As with all disaster preparedness, a clear plan that is arranged before a disaster occurs of how to set up a command center and who will be incident command is essential to smooth management of these events.”
“Again, prepare, communicate, know your roles…we can definitely do better for future victims of these horrible events.”
HSS at Waldorf Astoria…Honors William Salomon, Jo Hannafin, M.D.
On Monday, June 16, 2014 Hospital for Special Surgery (HSS) held its 31st Annual Tribute Dinner 2014 at The Waldorf Astoria in New York. The event, hosted by Brian Williams, anchor and managing editor of NBC Nightly News, honored William R. Salomon, the Honorary Chairman of Citigroup in celebration of his 100th birthday. Jo A. Hannafin, M.D., Ph.D., attending orthopedic surgeon and director of Orthopedic Research at HSS, received the Lifetime Achievement Award.
The event was attended by distinguished medical staff, celebrities, and outstanding athletes who have had their mobility restored by HSS. Also present were hundreds of leaders from the worlds of business, health, finance, media, sports, the arts, and government.
