Apr 2, 2014
Last week, an article appeared in the orthopedic peer reviewed literature reporting reasons for failure of Knee Replacement Prosthetic reconstruction within two years of the procedure. It is though such review and publications that we surgeons gain knowledge so as to offer the patient with arthritis, the most comprehensive informed consent. At the same time, it is only by reviewing our technology and surgical techniques that the surgeon is able to minimize unsatisfactory results and short lived outcomes. Understanding the cause of failure and type of revision knee arthroplasty procedures performed in the United States is essential in guiding research, implant design, and clinical decision making in Knee Replacement surgery. The most common cause of revision surgery is infection followed by implant loosening. Next comes malpositioning of components and failure of soft tissue balance leading to pain and limited motion. Patellar instability was also identified as a reason for patient dissatisfaction leading to an early revision. The average length of hospital stay associated with a knee revision was 5.1 days; this does not take into account, the rehabilitation center stay or time lost from work. The average total charges were $57,600; again, this does not take into account the costs of rehabilitation, outpatient antibiotics and ongoing physical therapy.
As readers of this Blog are aware, I maintain a Data Base containing outcome measures for every patient I have treated since joining the Regenexx Network and the Cellular Orthopedic initiative 22 months ago using Bone Marrow Aspirated Concentrate derived Mesenchymal Stem Cells for the care and treatment of Grade two and three knee arthritis instead of a knee replacement procedure. Last July, I presented a comparison of patients one year following stem cell intervention for an arthritic knee with historical data for those who had undergone a knee replacement one-year prior. At one year after a procedure, the stem cell cohort had more functional outcomes than those patients who had undergone a knee replacement. The two populations studied had one thing in common, an arthritic, symptomatic, life-style altering arthritic knee. My interest was peeked by the scientific article published last week concerning why Total Knee Prostheses had failed at two years; so I decided to review the complications of stem cell interventions for an arthritic knee and report them here:
Nothing is listed because there are no adverse outcomes to report. To date, to the best of my knowledge, no stem cell recipient for an arthritic knee in my practice has undergone a knee replacement. That may not be the case after another year of follow-up; but there has not been an infection or reportable complication in 22 months. The only “revision” procedures I have had to perform were three patients with repeat stem cell interventions to achieve a higher outcome score and several patients who requested booster PRP between four and nine months. The rescue of a failed stem cell intervention is a primary knee replacement; but to date, none have been reported. For your arthritic knee, Total Knee Replacement or try Stem Cells first?
Tags: arthritis, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Knee, Knee Pain Relief, Mature Athlete, Orthopedic Surgeon, Osteoarthritis, stem cells, Ultrasound Guided Injection
Mar 20, 2014
Osteoarthritis is essentially joint failure because all structures of the joint undergo pathologic changes. Traditionally, OA was considered to be a disease of articular cartilage, with loss of cartilage considered to be the essential pathologic process for OA. In recent years, however, it has been realized that OA affects the entire joint structure, including the synovial lining, ligaments, supporting subchondral bone, along with the articular cartilage. Each structure in the joint plays a unique and important in the daily function of the joint. Articular cartilage, with its compressive stiffness and smooth surface; synovial fluid, which provides a smooth and frictionless surface for movement; the joint capsule and ligaments, which protect the joint from excessive excursions; the periarticular muscles, which minimize focal stresses across the joint by appropriate muscle contractions; the sensory fibers, which provide feedback for muscles and tendons; and the bone supporting the cartilage (subchondral bone), with its mechanical strength and shock-absorbing function all interact in an intricate manner to provide optimal function for the joint. Destruction of any of these structures or a disruption in the balance between them leads to the process of arthritis.
A discussion of each risk factor is beyond the scope of this Blog but they may be divided into systemic categories (advancing age, gender, genetics) and local categories (anatomy, trauma, body mass, repetitive use injury, bone density). In considering the clinical features, there is no correlation between the X-ray and the degree of pain. The most likely sources of pain in OA are synovial inflammation, joint effusion, and bone marrow edema. All is dependent on and mediated by a loss of balance in the cartilage cell (chondrocyte) mediated balance between growth factors, cytokines and enzymes that breakdown the cartilage. OA becomes an inflammatory process initiated and propagated by inflammatory mediators that lead to the demise of the articular cartilage first and damage to other structures over time.
How might stem cells change the natural history of Osteoarthritis progression? The stem cells are chondrogenic when introduced into the proper environment. Even if they do not give rise to chondrocytes that are responsible for manufacturing collagen type 2 and aggracan; The Bone Marrow Aspirate derived Stem Cells when concentrated and introduced into the arthitic joint produce the cytokines and growth factors to control the breakdown of extracellular matrix by Interleukin 1-B and tumor necrosis factor-a. Difficult to understand? Call, make an appointment, I will explain and then you decide about a stem cell intervention rather than a Total Joint Replacement.
Tags: Clinical Trial. Mitchell B. Sheinkop, Interventional Orthopedics, Orthopedic Care, Orthopedics, Osteoarthritis, Regenerative, stem cells
Feb 12, 2014
Previous advances in orthopedic surgery have centered largely on surgical technique and surgical implants. I should know having dedicated almost 40 years of my orthopedic career to developing the cement-less prosthesis and refining the minimally invasive knee and hip surgical approach. The cement-less movement was the result of a clinical trial in which I was a co-investigator from 1979 to 2004 and the MIS approach was something I popularized in conjunction with a partial knee replacement (See News Releases-Rush University Medical Center April 28, 2000). I still am involved with the Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee. Yet it is my new world, biologics-including platelet-rich-plasma (PRP) and bone marrow aspirate concentrate (stem cells) that is emerging in orthopedic surgery due to their regenerative properties.
From a sports medicine standpoint, biologics are playing an increasing role in treating rotator cuff, meniscal, and cartilage injuries. For example, PRP is a growth factor therapy that is increasingly being used to augment healing after a partial tear of a tendon. My particular clinical practice and integrated clinical research is directed to helping patients with osteoarthritis of large joints manage symptoms, increase motion, and restore functional capacity both in the aging athlete or for those experiencing limitations in activities of daily living.
Stem Cells-cells that are harvested from bone marrow when aspirated and concentrated, have multiple capacities that make them unique. They can reproduce. They can differentiate into different types of cells such as cartilage and bone. They can release growth factors and other cell signaling molecules. As readers of this Blog are aware, I have implemented PRP and Bone Marrow derived stem cells into my clinical practice in the setting of osteoarthritis and I continue to collect data confirming positive results. The anti-inflammatory effect and pain reduction with increase in range of motion and functional capacity are no longer based on anecdote but rather statistically significant numbers. In the next several months, those who underwent stem cell intervention 18 months ago will be asked to complete quantitative MRI evaluation; and I will confirm in addition to all the benefits of stem cells as to how stem cells influence cartilage regeneration in my patients. It will be several years to confirm as to whether the Bone Marrow Concentrate will alter the natural history of the arthritic joint by bio-immune modulation as believed; and I will continue to monitor patients so as to assist an arthritic patient in possibly postponing or avoiding a joint replacement. Of particular interest is the feedback from several patients concerning the fact that their previous orthopedic surgeons are now undergoing training in how to become stem cell providers.
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Hip Replacement, Knee Pain Relief, Orthopedic Surgeon, Osteoarthritis, Platelet Rich Plasma, Regenerative, stem cells
Feb 6, 2014
There are several reasons behind the subject matter of this Blog. First, recent scientific studies have indicated that 2% of patients who have a joint replacement will have undergone a corrective revision within the first three years. Two percent isn’t a large number until it affects you. Approximately 20% of knee replacement recipients have significant pain and another 30 % fail to regain the desired motion confirming an earlier Canadian study in addition to those who fail outright at three years or less. Lastly, clinical studies at Regenexx have documented an average 15-point pain score improvement following a second stem cell intervention. Assume if you will that 100 points indicate a patient is pain free and prior to the Bone Marrow Aspirate Concentrate procedure, that patient had a score of 60. The average improvement after a stem cell procedure is to about 80 points. If you assume an additional 15 points will be gained by the second stem cell intervention, you will understand why I am writing this Blog.
We in the Regenerative Medicine world have been waiting a ruling by the DC Circuit Court regarding stem cell expansion and manipulation. The FDA allows Stem Cell intervention as long as those cells are not cultured or manipulated with external adjuncts. That is why we follow the Same Day Procedure in its present format. The Regenexx algorithm is FDA compliant. On February 5th, The DC Circuit sided with the FDA regarding stem cell culturing and manipulation with external agents. If you go stem cell “surfing” on the web, watch out for those sites marketing stem cell expansion and use of Adipose Derived Stem cells (SVF). I expect the FDA to go after several new SVF clinic networks within the year.
Meanwhile let’s return to the issue of a second stem cell intervention. If we can’t culture, we certainly may repeat. The Regenexx Data clearly support an average 15-point increase in a patient’s pain score when that second intervention is completed within a year of the index procedure. As many of my patients have experienced, to date, I have offered a booster PRP injection within three to six months when that patient wants more from the Same Day Stem cell undertaking. My approach has been helpful; although as of this time, I don’t know to what degree and for how long? For those contemplating a Bone Marrow Aspirate Concentrate minimally invasive treatment of an arthritic joint, be aware that there is now a way to predictably improve the ultimate outcome at 18 months with a second Stem Cell procedure.
Tags: arthritis, athletes, bone marrow, Bone Marrow Concentrate, Clinical Trial. Mitchell B. Sheinkop, FDA, Mature Athlete, Microfracture surgery, Platelet Rich Plasma, Regenerative Pain Center, Regenexx, stem cells
Jan 13, 2014
It has been cold, dark, and dreary for the past several weeks here in Chicago so I needed a change of scene. Too cold to enjoy the 12 to16 inches of snow accumulation over the holidays and then a sudden warm up with rain removing any chance of outdoor recreation. As an aging athlete, I was left with only one choice; so good cheer and greetings from Vail, Colorado, where I am spending the week skiing with my wife. Our stem cells are enjoying the rocky mountain high.
All year long, I attend to the aging athlete and the inherent musculoskeletal wear and tear. While the majority of my professional life had been dedicated to joint replacement for advanced arthritis, over the last several years, the goal has been to delay or possibly eliminate the need for a joint replacement with Regenerative Stem Cell intervention. Let me share with you what I have learned and observed as a result of my professional redirection; the advances based on stem cell focused regenerative medicine are a very significant contribution to the musculoskeletal care of the aging athlete. I am empowered to make the argument based on my patient responses and the data documented in our outcomes surveillance. What is so exciting to see first hand is the number of master skiers still excited about the sport. As it is after school vacation, the majority of skiers this week approach master athlete status; so much so that there no longer is a senior discount for the lift ticket. So what’s the magic in the care of the aging athlete?
First and foremost, be as thin as possible and still maintain good health. The reward will be a marked diminution in a propensity toward metabolic syndrome (hypertension and diabetes). If you don’t have the problems, you won’t need to medicate; less is better. While your genetics plays a role, the pursuit of fitness will make a difference. Where I am constantly reminded of the adverse consequences of anti-inflammatories, statins and the like, is when I harvest bone marrow and count nucleated cells for a mesenchymal stem cell intervention. The less prescription pharmaceuticals needed by a patient, the higher the nucleated cell count at the time of bone marrow aspiration and concentration. The number of my patients with knee and hip arthritis who are and will be enjoying the ski slopes this winter is significant; many who have been forced to forego the sport in recent years because of symptomatic hips and knees. If you want to ski again, return to a sport or for that matter, be pain free and avoid or postpone a joint replacement for arthritis; give it a though and give us a call for a consultation. 847 390 7666
Tags: arthritis, athletes, Clinical Trial. Mitchell B. Sheinkop, Concentrated Stem Cell Plasma, Interventional Orthopedics, Orthopedic Surgeon, Osteoarthritis, skiing, stem cells
