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INTRODUCTION

The IROM organization represents six centers across the United States overseen by a consortium of physicians, engineers and Ph.D. scientists collaborating to develop regenerative medicine science and technology. We conduct basic science research and multicenter clinical trials on primarily orthopedic applications of our stem cell, tissue engineering and regenerative medicine techniques. This organization is also in the process of developing consensus guidelines to govern the manner in which these institutes evaluate and treat specific orthopedic disease entities.

Physicians practicing in this area are specialized in interventional, non-operative, minimally invasive orthopedic procedures, and some have coined the term Interventional Orthopedic Medicine to distinguish these providers from orthopedic surgery specialists. Typically, these physicians are not orthopedic surgeons but rather interventional spine specialists with subspecialty pain medicine training as we will expound upon in this discussion. A new “hybrid” medical subspecialty has been emerging which we reference as “Interventional Regenerative Orthopedic Medicine.” In this discussion. we will review why there is a need for such distinction and what services, procedures and scope of practice these practitioners are currently working in. We will also review a number of case studies to provide examples of the techniques and methods used by our institutes and providers.

THE NEED FOR INTERVENTIONAL ORTHOPEDIC & REGENERATIVE ORTHOPEDIC MEDICINE

Hip and knee pain associated with osteoarthritis a common source of chronic pain in older adults.1 Prevalence of hip osteoarthritis ranges from 0.4% to 27%.2-4 Osteoarthritis (OA) of the knee is more common than the hip.5 According to the Agency for Healthcare Research and Quality, more than 600,000 knee replacements and 285,000 total hip replacements are performed each year in the US. The demand for repeat joint replacement or revision of the previous joint replacement will double in the next ten years. As the demand for joint replacement surgery increases, the supply of orthopedic surgeons performing these procedures are on the decline which may lead to a demand crisis.6

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Those seeking alternatives to chronic back and neck pain is also on the rise. The escalating cost of chronic back pain for example in the baby boomer population is staggering. In 2006 through 2007 the cost of treating the baby boomers with low back pain soared 129% from $15.6 billion in 2000-2001-35.7 billion in 2006-2007.7 The reason for this was estimated to be secondary to simply the “aging spine.”7 Primary care physicians are inundated with countless patients in chronic pain who are failing basic conservative management but are not considered candidates for a surgical procedure. These individuals often “fall through the cracks” and begin seeking alternatives. These patients find themselves caught in a seemingly “endless maze” of treatment options and yet continue to fail. Despite the complexity of spine pain and spine disorders, we believe the physicians specially trained in IROM have a unique skill set for both diagnosis and management of this patient population.

The primary care physician’s role in the future is going to continue to remain critically important. With reimbursement for services shrinking and the time demands increasing, with new healthcare regulations eating away at the time we once used to actually care for patients, the primary care physician is placed in a difficult position trying to sort out what to do with these difficult patients. To have a physician who is trained to manage the patient who seeks your care that is not responding to physical therapy and conservative care can be invaluable. It is even more valuable if the physician specialist specializes in “non-operative” management. Finding a superb orthopedic surgeon is not difficult. Finding a physician who has the subspecialty of advanced musculoskeletal and spine management, who is an IROM expert is like finding a “needle and haystack.” The IROM practitioner can provide early intervention and save cost, time, morbidity and disability.

As a primary care physician, you are well aware of the demands placed on the healthcare industry with the rapidly aging population. The “baby boomers” are living longer and are focused on health, fitness and an active lifestyle. Although this is true, an extremely active lifestyle can create increased incidence of musculoskeletal complaints and arthritis of large joints. The socioeconomic impact that the baby boomer population places on the field of medicine has created an unprecedented demand for alternatives for orthopedic and musculoskeletal injury, and degenerative disease. We saw this trend coming 20 years ago and prepared for it. Our organization has been preparing diligently to meet the demands that will be placed before us in dealing with patients with chronic musculoskeletal complaints. The primary care physician remains the portal of entry into the healthcare system and will need to gradually become more and more familiar with the methods and technical expertise of these new interventional orthopedic and spine specialists. We are poised to provide additional educational services, or meet with your staff or provide postgraduate education to primary care physicians regarding the science and technology we utilize.

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HISTORY OF INTERVENTIONAL REGENERATIVE ORTHOPEDIC AND SPINE MEDICINE

This discipline of interventional regenerative medicine has been in a state of evolution for a number of years. There are no residency programs or traditional medical training programs in this field to date. Currently, there are only two or three cell training programs worldwide. Fifty years ago the field was comprised of a handful of physicians who were considered “mavericks” using special injection techniques to cause the proliferation of collagen and connective tissues in ligaments and tendons. Physical Medicine and Rehabilitation physicians began to take an interest in these simple interventions and started conducting clinical trials and research in some of these earlier techniques. These early methods involved the use of hyperosmotic dextrose injections which caused osmotic cellular injury, thereby releasing tissue growth factors that stimulated fibroblasts to produce collagen in tendon and ligament tissues. In 1993 we personally brought together a medical pathologist and a veterinarian institution to begin work on the use of platelet-derived growth factors to induce tissue healing of tendons, ligaments and the annulus fibrosus in lumbar discs, in animals.

We were utilizing plasmapheresis to obtain platelet concentrates. Others began to view this process as too cumbersome and developed simple centrifuge techniques, which were then adopted by physicians around the world. This ultimately spawned many companies which now make and sell various Platelet-Rich Plasma (PRP) centrifuge systems for this purpose. This was only the beginning some 20 years ago. With approximately 700 articles published over this period of time, 50% showing clinical efficacy and 50% showed no statistical difference from placebo to control groups, there continued to be numerous unanswered questions with the utilization of these early techniques. It was not until meta-analysis data became available from all of these studies that we began to understand that there were specific laboratory preparations of Platelet-Rich Plasma that were favored in specific conditions. In other words, you have to match the right protocol to the right condition.

Physicians with skills in ultrasonography began to implement precision injection techniques to target tissues with visual defects such as tendon tears and degenerative changes. With image guided injection techniques we began to see improved clinical outcomes. At the same time, various autologous stem cell therapies began to emerge providing physicians who possessed specialized skill and experience in these techniques more diverse choices of therapeutic intervention for specific disease entities. Later we began to understand the importance of tissue engineering techniques and began to integrate the use of extracellular matrix proteins, connective tissue scaffolding techniques with other biologic interventions and stem cell. We began to realize that stem cell therapies were only a small component needed to heal various soft tissue pathologies. We spent years developing the laboratory techniques and exploring what other companies and laboratories had developed to be used in conjunction with our regenerative and biological interventions. We learned that the protocol used with each disease state needs to be unique and well thought-out to improve clinical outcomes. We also could not have accomplished what we have without the collaborative efforts of a “Physician and Basic Science Consortium.” A group of like-minded physicians and scientists with similar training and experience, came together three years ago and began to collaborate and share intellectual properties, techniques and methods and most importantly began to develop consensus about disease management. These collaborative efforts lead to our current “tissue engineering approach” and to our Interventional Regenerative Orthopedic Medicine Institutes.

THE MODERN IROM PRACTITIONER

The modern orthopedic and spine regenerative medicine practitioner is a physician who has diversified their skills. Physiatrists or doctors of physical medicine & rehabilitation with fellowship training in spine and interventional pain medicine have for the most part been behind the development of this field. We are now seeing anesthesiologists with fellowship training in interventional pain medicine, sports medicine physicians and orthopedic surgeons joining these efforts to advance this field. Interventional orthopedic practitioners utilize primarily “non-operative” orthopedic procedures in managing spine and joint conditions.

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These practitioners must devote years of training to master ultrasonography and integrate diagnostic musculoskeletal ultrasonography and ultrasound guided procedures with the fluoroscopy techniques they have already mastered. They require advanced training and knowledge in orthopedics, biomechanics, sports medicine, rehabilitation, manual medicine and to some degree alternative medicine. They must understand how to read MRI’s and CT’s and integrate the physical assessment, ultrasonography examination with other diagnostic imaging to provide a precise diagnosis. They require special training well beyond their fellowship training to develop an understanding of soft tissue injury, and degenerative disease of cartilage, ligaments, tendons, muscles, and connective tissues. They are also integrating their skills with peripheral entrapment neuropathies and other neurologic conditions.

Patients who seek the care of these specialized physicians are often those who have spent months or years in conservative care which includes medication, physical therapy, chiropractic or osteopathic manual therapy, acupuncture, massage therapy and a host of other alternatives. They have failed pharmaceutical management, corticosteroid injections, and often surgical management. The IROM practitioner is an injection specialist but typically does not emphasize the use of corticosteroid injections. These practitioners seek to utilize special technologies aimed at healing soft tissue, degenerative disease or injury. They also must have a keen understanding of post-procedural rehabilitation care and protocols. This saves time and money as well as the physical and emotional effects of chronic pain on an individual. The modern day orthopedic regenerative medicine specialist requires a different skill set than typical physical medicine physicians or sports medicine physicians and requires several additional years of hands-on advanced clinical training to add to their foundational subspecialty training.

WHAT CONDITIONS DOES AN INTERVENTIONAL REGENERATIVE PRACTIONER TREAT?

We specialize in orthopedic, spine and musculoskeletal medicine. We deal with injuries, degenerative joint disease and difficulties involving:

  • Low back pain
  • Neck and mid back pain
  • Foot and ankle
  • Lower extremity including knee and hip
  • Shoulder
  • Elbow, forearm, wrist and hand
  • Peripheral entrapment neuropathies
  • Myofascial pain syndromes
  • Headaches

The area of orthopedics, spine and musculoskeletal medicine is a vast subspecialty that requires knowledge of the musculoskeletal system including functional anatomy, biomechanics, orthopedic pathology involving muscles, tendons, ligaments, cartilage and bone disease. Many individuals do not appreciate the complexity of musculoskeletal medicine. We live in an era of a fitness boom which has reduced cardiovascular and other risk factors but has also led to issues of cumulative joint trauma, sports and recreational injuries leading to progressive degenerative disease. Obesity and sedentary lifestyles have also had a toll on these individual’s spine and joints. Regardless of the cause, we have an aging “baby boomer” population that is going to have a significant socioeconomic impact on the medical system that is providing care for these musculoskeletal and orthopedic conditions.

We believe that the advanced Interventional Regenerative Orthopedic Medicine practitioner is well positioned to intervene for these patients when there are complex clinical presentations and often multiple joint involvement. The IROM practitioner needs to be willing to spend considerable time with an individual patient dealing with the complexity of clinical presentation. The typical 10-15 minute office visit is not possible with this patient population. You do not have the luxury of dealing with one problem at that time because insurance reimbursement does not allow otherwise. It is common place to spend an hour or more with each patient. The complexity of these clinical presentations and the complexity of interventional techniques requires this devoted time and attention to detail. This topic is so vast we could write a textbook. We felt that the best way to communicate to a physician to demonstrate our unique approaches would be to present a series of these cases to allow one to develop an understanding of how an IROM practitioner would handle specific clinical entities and to contrast the differences between conventional approaches in sports medicine, interventional pain medicine and physical medicine & rehabilitation to the IROM approach.

IROM INSTITUTE

Currently, we have six institutes scattered around the United States. These locations include Texas, Pennsylvania, Ohio, Florida, California, and Bellevue, Washington. These facilities are equipped with a full fluoroscopy suite. This prevents us from having to go to the OR and outpatient surgical centers for procedures thus significantly reducing the expense for our patients. We are also equipped with an ultrasound diagnostic and procedure suite, a stem cell and biologic lab, and a rehabilitation facility for spine and extremity rehab. We are able to perform all of our procedures same-day with all cell isolation and laboratory preparation performed within the institute.

Engineers, Ph.D. stem cell scientists and stem cell biologist are affiliated with our institution and assist in our research and development and bench research, and provide assistance in clinical trials. Our engineering team provides a means for us to develop our instrumentation and proprietary technology for which we are currently working on for 510K FDA approval.

CHRONIC NECK AND BACK PAIN: OUR APPROACH

Our physicians have abandoned many of the traditional approaches of the pain medicine physicians. We believe that repeated corticosteroid injections, repeated epidural blocks, etc. provide little long-term benefit. We limit the use of corticosteroid epidural injections. We also believe that traditional approaches involving radiofrequency ablation procedures provide at best transient symptomatic relief until medial branch nerves regenerate when the procedures then have to be repeated again and again. Chronic opioid management has been a dismal failure in this country. We also feel strongly that interventional pain physicians that utilize a “let’s try this” approach with injection procedures is inappropriate.

We strive to provide “precision diagnosis and definitive therapeutics.” In order to accomplish a precision diagnosis with the chronic back or neck pain patient a significant time is spent with the patient and a detailed evaluation which may include local anesthetic pain mapping procedure and advanced sequential diagnostic testing that is done on the same date of service. Commonly, patients with back pain have multiple pain generators. This increases the complexity of the clinical presentation. We try to sort out all potential pain generators and develop comprehensive interventional treatment plans directed to all of the pain generators. We also have a comprehensive understanding of spine rehabilitation protocols, and integrate our understanding of manual therapy, alternative therapies and physical rehabilitation with our interventions.

Many physicians in primary care may not realize how many alternatives are currently available for even a simple clinical presentation such as a herniated disc. We have taken a surgical approach far too often in the US, while the rest of the world has been developing more reasonable and minimally invasive procedures that can deal with herniated disc patients that are resulting in outcome similar to surgery. We have explored these alternative methods and utilize them on a regular basis. There are numerous types of disc protrusions and herniations. Treatment needs to take into consideration. A careful diagnostic categorization process and to take into consideration a number of pathophysiologic processes that may be occurring. We undertake painstaking efforts to use specific categorization processing to develop the correct treatment protocol.

We believe the key to success is again a precision diagnosis. The procedures provided need to be done in appropriately selected patients. We have worked extremely hard in our institutes to develop consensus guidelines that govern the manner in which we select patients for given procedures based on collective clinical outcome data and experience. We encourage all primary care physicians to feel free to contact us to discuss difficult cases since the approach must be customized for each patient’s presentation.

NERVE ENTRAPMENT SYNDROMES?

The interventional orthopedic practitioner also possesses specialized skills in dealing with countless nerve entrapment syndromes. With years of study utilizing ultrasound diagnostic evaluation of nerves and specialized ultrasound- guided procedures directed to nerve entrapment syndromes, the interventional practitioner can often help people with intractable nerve entrapment pain that has been unresponsive to other conservative care or even surgery. Pioneers from Japan and other parts of the world have integrated the use of advanced ultrasound procedures, regenerative medicine principles and non-surgical methods to decompress the nerve. We have adopted and learned from these providers and utilize these methods in our centers. For example, a patient with ulnar neuropathy or cubital tunnel syndrome may experience ongoing ulnar distribution symptoms of numbness, tingling and pain. Typically, these patients are referred for electrodiagnostic testing followed by referral to surgery for ulnar nerve transposition surgery.

It is our opinion that neural sonography (ultrasonography of the nerve and the nerve pathway) should be performed in addition to electrophysiologic testing. Often, ultrasonography examination of the region of nerve entrapment reveals certain findings and clues to pathology that is not provided by conventional electrodiagnostic testing. Ultrasonography can reveal information about the location and cause of a specific entrapment neuropathy. Not only can provide information on the possible etiology of the entrapment neuropathy but also may provide information in regards to the degree and severity of nerve dysfunction and pathology.

For example, a patient may have presentation of ulnar neuropathy at the elbow after a traumatic injury but present on ultrasound with intraneural fibrosis. This patient will do poorly with ulnar nerve transposition procedure. Other patients may demonstrate signs of compressive neuropathy with increased neural fascicle size secondary to connective tissue entrapment. In these patients, a special procedure performed under ultrasound guidance is utilized to track a needle next to the nerve and use a connective tissue neural fascial hydrodistention of the tissues away from the nerve often relieving compression and returning nerve fascicle size and function to normal. This can be performed without the use of decompression surgical procedures or nerve transposition. We feel the simple procedures should be attempted prior to consideration of surgical intervention.

ARE THESE SERVICES COVERED BY INSURANCE?

Unfortunately, the majority of our procedures are not covered by insurance. We have adopted a fee for service practice model. We have worked extremely hard to develop our laboratory processing, procedures, and methods to bring the cost of our care to a minimum so that individuals are paying reasonable rates for even our most advanced cellular based technologies. We have a host of choices, alternatives and procedures and take pride in trying to avoid unnecessary expense. We offer each patient the technology that is the most appropriate method of treatment for the best possible clinical outcome.

BREAKTHROUGHS IN REGENERATIVE MEDICINE TECHNOLOGY AT OUR CENTERS

Over the course of the last five years, the physicians within our organization have been working diligently with Ph.D. basic scientists and engineers to develop new regenerative technologies, laboratory preparation procedures, and a host of techniques and protocols that we have been testing over throughout this time period. Members of our team have obtained FDA approval for some of their innovations. We are working on more at present date. We have, proprietary laboratory processing techniques utilized for innovative stem cell isolation.

Our stem cell technologies again are carefully integrated with other regenerative and dorsal biological interventions to improve clinical outcomes. We are currently utilizing proprietary protocols and techniques to manage discogenic back pain as previously stated.

IN SUMMARY

IROM practitioners is a rapidly emerging subspecialty field in medicine that may provide the primary care physician another option for referral to subspecialty consultation in selected patients. This type of service is typically utilized for patients who are not responding to conventional/conservative means and is seeking nonsurgical intervention. These patients often find themselves frustrated and living with chronic pain seeking alternatives for treatment. We hope this information has been helpful for your review. If there are any questions you may have or if you would like to hear from us for further information, please do not hesitate to contact us.

REFERENCES:

  1. Jensen KT, Rabago DP, Best TM, Patterson JJ, Vanderby R, Jr. Response of knee ligaments to prolotherapy in a rat injury model. The American journal of sports medicine. 2008;36(7):1347-1357.
  2. Andrianakos A, Kontells L, Karamitson D, al. E. Prevalence of symptomatic knee, hand and hip osteoarthritis in Greece. The ESORDIG study. . J. Rheumatol. 2006;33:2/5/07-2513.
  3. Dagenais S, Garbendian S, Wal E. Systematic review of prevalence of radiographic primary hip osteoarthritis. Clin Orthop Related Res. . 2009;246:6623-6637.
  4. Gunther K, Puhl W, Brenner H, Sturrmer T. Clinical epidemiology of hip and knee joint arthrosis an overview of the results of the “Ulm osteoarthrosis study”. . Z Rheumatol 2009;61:244-249.
  5. Cross M, Hoy D, Nolte S, Ackerman I, al. E. The global burden of hip and knee osteoarthritis: estimates from the Global Burden of Disease 2010 study Ann Rheum Dis doi:10.1136/annrheumdis-2013-204763.
  6. Iorio R, Kurtz S, Lau E. The Journal of Arthroplasty Vol. 25 No. 8 2010.
  7. Smith M, Davis M, Stano M, Whedon J. Aging Baby Boomers and the Rising Cost of Chronic Back Pain:

Our Bellevue, WA and Monterey, CA physician, Michael N. Brown, MD

Dr. Brown, our Washington and California based IROM physician has a unique background in that he began his career as a chiropractor and later worked extensively in chiropractic and osteopathic manual therapy, acupuncture dry needling, sports medicine, orthopedics and neurology. His extensive experience in ultrasonography, biomechanics and clinical orthopedic assessment is integrated with his alternative medicine background, providing patients a unique experience with his multidisciplinary approach and comprehensive evaluation process.

Our Florida physician, Heather Smith-Fernandez, MD

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