Biological Joint Preservation

Biological Joint Preservation

An Overview for Patients:

by Matthew Harris MD, MBA

Biological Joint Preservation is a broad encompassing category that includes everything from Viscosupplementation, to Stem Cell Therapy, to PRP Treatments, and more Stem Cell and PRP Therapies are covered in detail on separate pages so please feel free to click on them for more information. On this page, we are going to focus predominantly on Viscosupplementation and other biologics.

All of our joints contain a lubricating and nourishing liquid called Synovial Fluid. Synovial Fluid is made by the cells that make up the lining of our joints, the synovium. The job for some of these cells (Type B) is to filter the blood that they receive in order to produce this very specialized fluid that contains many proteins, molecules and substances which they then excrete into the joint. The other cells act like cleaners, and will remove the old fluid and broken down by-products that are circulating in the joint.

The proteins, molecules and substances in the fluid essentially nourish the cells in the cartilage that lines our joints. So clearly, this fluid plays a very important role in maintaining the health of our joints. Two of the key proteins that are found in our synovial fluid are Hyaluronin and Lubricin. As its name implies, Lubricin plays a crucial role in giving joint fluid its "slippery" characteristic that in turns helps joints to move and glide smoothly with little friction. Hyaluronin (seen below) is a Glycosaminoglycan that is made up of several building block proteins which many of you have heard about. We'll get to why people take some of these as supplements in just a bit. In the meantime, they include:

1. Chondroitin Sulfate

2. Heparin Sulfate

3. Keratin Sulfate

As our joints develop Arthritis, the quantities of these molecules and proteins begins to change as the body attempts to heal the damaged cartilage. Unfortunately, the body has no good way of regenerating cartilage on its own, and over time, changes occur in the fluid as a result of this attempted healing which actually makes synovial fluid become LESS effective as a lubricant. Ironically, this leads to more cartilage damage and worsening arthritis symptoms, and before you know it, your painful joint is trapped in a vicious cycle that can be very difficult to escape.

One of the more predictable changes that occurs in arthritis is that synovial fluid becomes "watered down." An early response by our cartilage cells when they are injured or worn down as occurs in trauma and arthritis is that they intentionally accumulate more water. They do this for several reasons, but essentially, taking in more water helps bulk them up and make them a bit more resistant to getting squeezed with walking (like inflating a water balloon more), and it also attracts more nutrients that are needed for the repair attempt. As a result though, more of this water finds its way into our joints than is otherwise supposed to be there. Anyone who has ever added water to oil to dilute it, whether it be while cooking, or when trying to wash it off your hands after working on your car knows that watered-down oil is not nearly as thick or slippery. This is exactly what happens in our joints. As our bodies attempt to "heal" damaged cartilage cells in cases of arthritis, they actually make the situation inadvertently worse by creating synovial fluid that does a poor job lubricating the joint.

Along came the thinking that maybe we could perform an "oil change" on our joints...essentially remove the bad "watery joint fluid" and replace it. Long ago, physicians would intentionally drain fluid from swollen joints. They understood that it was fluid which wasn't normal, and their hope was that if they removed the "bad fluid", the body might be able to eventually replace it with good, new fluid. These early physicians were on the right track, but they didn't yet have a full understanding of what was making this fluid not work properly. Fast-forward to today: we now understand a vast majority of the complex processes that involve arthritic degeneration of our cartilage, as well as, inflammatory changes that occur within the synovium in diseases such as Rheumatoid arthritis, along with the changes that happen in our synovial fluid as a result of these pathologies. But we still have a long way to go.

Approximately thirty years ago, scientists began experimenting with different substances in an attempt to replicate healthy human synovial fluid. They stumbled across the protein Hylaluronin in an unusual place - rooster combs! Several years of testing proved to be very inconclusive, and their research fell by the side. Fortunately, our European colleagues picked up on it and resumed testing. After several years of well-designed testing, they discovered that isolated injections of Hyaluronic acid not only alleviated some symptoms of arthritis, but in some people, it actually led to resolution of all pain for sometimes five or even ten years. This re-ignited an interest among physicians in the US, and a short time later in the 1990's the FDA approved the use of Synvisc and Hyalgan. Both products are proprietary injections of highly concentrated Hyaluronic acid that is collected, purified and prepared from the combs of roosters.

The term Viscosupplementation refers to the usage of such preparations of Hyaluronin products that are injected into a joint in order to bolster the viscosity and lubrication capability of the native synovial fluid which is diluted as a result of the arthritic disease process. Also, we now understand that there are secondary effects which occur as a result of this injection, which may also explain why it seems to work in certain conditions, even certain people, and not others.

The National Government has placed very strict guidelines on the use of viscosupplementation here in the US, and all of the other major insurance carriers have followed suit. What that means is that in order to be eligible to have your insurance cover this treatment, you must first meet several conditions. For starters, only arthritis of the knee and shoulder are eligible. We are working very hard on securing widespread approval for use in the hip as well, but currently these treatments are not covered by your insurance. This is not to say that you couldn't simply pay for these out-of-pocket, but our goal is to keep such costs for you to a minimum. As we were saying, there must be:

-- Radiological evidence to support the diagnosis of osteoarthritis; and,

-- There is adequate documentation that simple pharmacotherapy (ASA, Tylenol, Celebrex, etc.), or exercise

and physical therapy has been tried and the patient has failed to respond satisfactorily

As per the AAOS Clinical Practice Guidelines using Evidence Based Medicine, all patients with symptomatic arthritis of the knee are strongly recommended to participate in self-management programs, strength-training, low-impact aerobic exercises, and neuromuscular education; and engage in physical activity that is consistent with national guidelines.

Interestingly, these same AAOS Guidelines take a Strong stance against recommending the use of hyaluronate-type injections to the knee for treatment of osteoarthritis symptoms. There has been ample research conducted that appears to show benefits of using these injections, but when examined as a whole across the entire industry to include all patients...we simply cannot say that the efficacy of these injections has been overwhelmingly positive.

This is not to say that the injections do not work at all. In fact, there are thousands and thousands of people that will attest that they work almost like a miracle. But we can also find just as many patients who can honestly say that they received no benefit whatsoever. Why is this you ask? Because everyone from the person with just a little early arthritis to the person with full-blown-I-can-barely-move arthritis were included in this research. Ironically enough, people from all levels of severity gain relief though. This goes back to what I alluded to when I said that we are only now beginning to discover that there is much more than meets the eye when it comes to arthritis. On the microscopic level, and at the cellular level, there are chemicals and characteristics of arthritis that make two patients who may have identical XRays and symptoms, in fact, be very different from one another. We're beginning to understand why some people receive relief while others do not from treatments such as these. But until we have all the answers and can accurately predict who will respond to an injection, and who will not, it is our responsibility to offer sound and unbiased medical advice to our patients. Dr. Harris is more than happy to answer your questions and discuss this further at your appointment.

With that said...today in the US, we have a number of viscosupplementation products that are on the market:

1. Synvisc (Genzyme) - 16mg/2ml ; 1 injection weekly x 3 weeks

a. Synvisc-One (Genzyme) - 48mg/6ml; 1 injection every 6 months

2. Hyalgan (Fiddia Pharma) - 20mg/2ml; 1 injection weekly x 3-5 weeks

3. Supartz (Bioventus) - 25mg/2.5ml; 1 injection weekly x 3-5 weeks

4. Euflexxa (Ferring) - 20mg/inj; 1 injection weekly x 3 weeks

5. Orthovisc (DePuy / J&J) - 30mg/2ml; 1 injection weekly x 3-4 weeks

6. Gel-One (Zimmer) - 30mg/3ml; 1 injection weekly x 3 weeks

VIDEO: Supartz has a nice video posted on their website that illustrates how each of these supplements is injected.

In fact, each product website is designed to provide information and advice to prospective and interested patients who have symptoms of osteoarthritis and qualify for treatment. That information of course, is going to be rather biased in favor of the site that you are one. Many orthopedists will arrange to provide only one brand of the injections above. In fact, you will notice that some sites offer to "refer" you to a "recommended" physician who specializes in their product. Dr. Harris believes in loyalty to his patients over loyalty to a single product or company, so you will not find him on any of these product websites for that reason. Instead, we are pleased to offer all of these injections at the JPLRC and we are more than happy to discuss with you the subtle differences between them. The reason that Dr. Harris offers each of them is that there still has NOT been one clinically significant difference in outcomes or safety to indicate that one is superior to the rest, as supported by a well-designed double-blinded, prospective, randomized controlled trial when comparing all of these injections. Until such a trial is conducted, any claim that you hear one company making that their product is superior to another is simply promotional tactics.

So which one should you choose? Until one of them proves to be far superior over any of the others, Dr. Harris's answer to that question is simple. Unless you personally own stock in one of the companies above and want to add to your quarterly dividend by giving them your business, or if you have a friend who had a particular one and he/she

recommends the same to you (or vice versa if they warn you to stay away from any), then lets choose one that suits your needs, works favorably with your threshold for tolerating needles, and is covered by your insurance. We can usually narrow it down to one or two after that, and then we can help you choose.

What to expect from the injection: None of these viscosupplementations have an immediate pain relieving effect. That being said, if you have an effusion prior to injection, and that fluid is first removed prior to injection of the Viscosupplementation, you may feel immediately better but this is likely to be from removing the excess fluid that contained high concentrations of inflammatory molecules. You should avoid any vigorous exercise or prolonged walking or standing for approximately 48 hours after the injection. Many patients experience swelling, redness and localized pain at the site of the injection. It is best to place a cold pack on this location, and alternate the cold pack with periods of it on and off until the symptoms subside. It varies widely, but some patients will report feeling relief in their symptoms after only the first injection, whereas, others will not feel any improvement until the entire course has been completed. The length of relief also varies from either a very short duration of days to weeks, all the way up to months and years.