Joint Degeneration and Arthritis

Paul L. Reller L.Ac. / Last Updated: August 03, 2017

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In 2010, with the number of hip replacements performed approaching 200,000 per year and climbing, the number of complaints of adverse events and failure of the metal-on-metal hip replacements alone, which account for over 60,000 of the prosthetics implanted per year, reached over 5000 per year. By the end of 2011, the number of failures of metal-on-metal hip prosthetics mushroomed to a catastrophic number. The New York Times reported in a December 28, 2011 article entitled Common Failure of Hip Implants Bring Big Costs (Harry Meier) that an estimated 500,000 patients had received an all-metal hip replacement prosthetic by 2011, accounting for over a third of the hip replacement prosthetics until alarming reports of failure prompted large recalls and discontinuation of these types of prosthetics. A single type, manufactured by the DePuy division of Johnson and Johnson, was implanted in 40,000 patients in the United States, and recalled in 2010 due to a high rate of failures and adverse risks from metal debris in the surrounding tissues and circulation. The metal debris resulted from both movement of parts against each other and corrosion. In 2011, the Bloomberg report stated that the failure rate of this one type of prosthetic in the United Kingdom reached 49 percent by year six after the first revision. The settlements of these cases involving failed prosthetic joints has generated remarkable financial liability for patients, as hospitals and insurers often settle for a relatively small recompense and pass the remainder of the bills to the patient, according to the New York Times investigation. For patients receiving a direct settlement, liens from the insurers and hospitals often are much larger than the personal settlement, creating enormous economic stress for the patient, who is usually unable to work. The Times article cited a recent study that showed that in the last 5 years, no new artificial hip or knee replacement device introduced to the market was more durable than older devices, and some 30 percent of these "advanced" devices were less durable than older models. An FDA report, however conservative, reveals that the metal flaking and release of metal ions into circulation presents a real risk. Click this link to see the FDA warning: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm.

An article in the February 22, 2012 New York Times, entitled Hip Maker Discussed Failures, outlined the evidence that the maker of a recalled hip prosthetic, Johnson and Johnson and its subsidiary DePuy Orthopedics, knew of the early rate of failure of a metal-on-metal prosthetic hip replacement that was inserted in over 93,000 individuals, and delayed action on recalling the prosthetic. Widespread clinical reports that the artificial hip was failing in less than three years for many patients was attributed to failure by the surgeons in company memos. The prosthetic is known as an articular surface replacement, or ASR. A year before the recall, an internal email that has since been uncovered, revealed that the FDA had refused to approve the device, yet the FDA report had been kept confidential, rather than publicly reported. The hip prosthetic had experienced a high rate of failure, or need for early revision (a second prosthetic surgically inserted), during the clinical trials of the device. The FDA does not release such decisions of non-approval as a matter of policy, citing protection of confidential business information. The decision of the FDA to deny approval of the device was not passed on to doctors, hospitals, clinics and patients as the prosthetic was marketed. Instead, the device was heavily marketed abroad in 2003, while a version of the prosthetic was marketed in the United States, which was later the subject of the 2009 FDA decision. Despite this evidence, the company executives continue to assert that the decision to stop selling the device was "purely a business decision", reflecting declining sales.

In response to these alarming failures of the hip replacement prosthetics surgeons in the United States did not recommend increased caution and a return to use of the prosthetic hip replacements on a more narrow subset of elderly patients with severe degeneration, but instead touted a new type of metal-on-metal hip prosthetic called "resurfacing". This type of hip replacement was heavily promoted to younger patients with the promise that less of the femur, or thigh bone, was removed, leading to safer outcomes, more mobility, and a greater degree of success with replacement of the prosthetic. In reality, studies showed in 2012 that the outcomes for these hip prosthetics were not better than other metal-on-metal hip replacements, but did come with one advantage for the doctors, clinics and manufacturers, namely that the patient could not sue for failure. A New York Times article of October 2, 2012, entitled Warning About Alternative Hip Implant Procedure stated that while traditional metal-on-metal hip prosthetics have largely disappeared due to the large number of lawsuits, the FDA 'fast-tracked' the new resurfacing type with clinical trials from the company showing favorable data. Researchers at the University of Bristol, UK, headed by Dr. Ashley W. Blom, followed 32,000 patients with these "resurfacing" metal-on-metal hip replacements, though, and found that women and younger men had an "unacceptably higher" early failure rate than even the traditional metal on plastic early hip prosthetics, and that the same problems with metal molecule "flaking" existed. Experts are now questioning the way these devices were "fast-tracked" by the FDA. Dr. Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, was quoted: "If resurfacing hip replacement devices are found to be unsafe, then the implications are grave." The manufacturers, such as Smith and Nephew, replied that these resurfacing hip replacements were intended for a target population of older men of larger stature, with bigger femurs, and took no responsibility for the marketing of these devices to women and younger men. Unfortunately, these many patients with early failure and health problems related to metal ion toxicity will not be able to sue for damages in the United States.

In January of 2013, the U.S. FDA proposed new rules concerning hip prosthetics, closing a loophole in the 1976 federal law under which medical devices were first regulated. This new guideline, The Safety and Innovation Act of 2012, would require makers of hip prosthetics with all-metal components to prove that these devices are safe and effective before they could continue to sell existing artificial hip prosthetics, or obtain approval for new all-metal designs. The FDA found that when warnings and non-approvals were issued, makers of these artificial hip replacements could legally market new devices that "resembled" existing models not recalled without conducting human clinical trials to prove safety. In 2011, the U.S. Congress finally approved the power to regulate medical devices that "resembled" existing models, allowing the FDA finally to have the powers to protect the public from such fiascos as the metal-on-metal hip prosthetic, which led to the 2012 law. Under prior rules imposed by the Bush Administration, though, the FDA would have had to conduct studies that often took years, called economic reviews, to show that an FDA decision on a medical device would not adversely effect the economic viability of the manufacturer before denying FDA approval for devices that resembled previously approved prosthetic designs. The new guidelines for hip prosthetics, though, under the Obama administration, will also require doctors to monitor patients with metal-on-metal hip replacements, and when symptoms occur, to test the blood for levels of metallic ions that could result in heavy metal toxicity. Unfortunately, we have learned too late that the circulating levels of heavy metal toxins from the prosthetics are not the right indicator of disease. Tissue biopsy is needed. The manipulation continues.

Also in 2013, a study 35,140 patients that had received hip replacement (total hip arthroplasty) at Kaiser Permanente Hospitals showed that women had a 29 percent higher rate of failure in the first 3 years of the hip replacement, despite a higher proportion of women receiving a metal-on-polyethylene prosthetic rather than the metal-on-metal arthroses favored in the larger hip prosthetics installed in men. The failure rate for women receiving metal-on-metal hip replacements was much higher than that of men receiving this problematic type of prosthesis as well. Since total hip replacements are performed more often in females, and rates of diagnosis of osteoarthritis in women are higher (approximately 26 percent of women in 2010 in the United States), this finding may alter advice in treatment planning for women. This represents the largest study to date in the United States of total hip replacement failure rates, and was published the Journal of the American Medical Association (JAMA Intern Med 2013; 3271) online. Prior studies also showed that patients receiving total hip replacement before the age of 55 had a significantly higher failure rate. These outcome measures point to the need to adopt a more comprehensive conservative approach to osteoarthritic joint degeneration at an earlier age. An approach that integrates Complementary and Integrative Medicine, patient education, improved therapeutic maintenance, and treatment of underlying causes of osteoarthritic joint degeneration will greatly reduce the need for these total hip replacements, and revisions, and save the United States a large amount of money in total healthcare expenditures.

We have known for some time that there was a big problem with hip replacements, with even a successful prosthetic providing only a short number of years of function for many patients. A relatively small number of hip replacements are maintained in healthy individuals for up to 15 years, which is considered the best outcome. Most experts in 2012 state that these hip replacements are "supposed" to last 10 years before requiring a replacement. For a large percentage of patients, though, this time span is considerably shorter. In 2002, an NIH population study by Brigham and Women's Hospital, Harvard Medical School found that over 37,000 revisions (replacement surgeries) were performed each year in the United States, at the cost of over $31,000 per surgery, indicating a high rate of failure of the first prosthetic. Since 2002, this number, and the costs, have grown dramatically, and the need for a second hip prosthetic has occurred in hundreds of thousands of patients. The full recovery time for this procedure often reaches 6 months, adding the cost of time off work and rehabilitative therapy. Revision replacements have a higher incidences of failure and adverse effects, and a shorter life span of the prosthetic. A third revision is almost never successful, eventually leaving the patient an invalid. While the advances in total hip and knee replacements are remarkable, many intelligent patients are opting for a more conservative course of joint rehabilitation before resorting to this problematic and risky solution. While standard medicine continues to imply that the only options are mild exercise and corticosteroid injections, the research today shows that a treatment protocol integrating acupuncture, electroacupuncture stimulation, herbal and nutrient medicine, direct soft tissue physiotherapy (Tui na), and proper neuromuscular reeducation is able to stimulate functional regrowth of the joint cartilage and surrounding tissues, and reverse osteoarthritis, which accounts for about 94 percent of the cases receiving hip and knee replacements. Some of this research proof is provided below in Additional Information with links to the studies. In addition, recent research has found that specific herbal chemicals may reverse or control rheumatoid arthritis, and may also be combined in a total treatment package with acupuncture, nutrient medicine and physiotherapy.

The complex issue of heavy metal toxicity from micro-debris flaking from metal hip prosthetics

While the release of very minute metal particles from normal wear of a metal on metal hip prosthetic is gradual, these heavy metals may produce toxicity in the body. The extent of this toxicity, and the eventual harm to health, are difficult to measure, though. In September of 2013, a study at the Otto-Von-Guericke University, in Magdeburg, Germany (Lohmann CH, Meyer H et al), published in the Journal of Bone and Joint Surgery, American Volume (American Orthopaedic Association), found that while there is no measurable cancerous or fetal mutation toxicity, that studies show that accumulation in the tissues surrounding the prosthetic, not the blood serum level, are predictive of pathogenic immune response. Higher levels in these tissues advanced the heavy metal toxicity from a lymphocytic infiltration to an accumulation in immune macrophages, with fibrin exudation noted as well. Cobalt chromium (CoCr) has been the main concern, as well as molybdenum. Both hypersensitivity reactions and immune dysfunction are a concern. Study at the University of Leeds, United Kingdom (cited below), also shows that at 40 weeks post exposure to heavy metal toxicity, or accumulation of nanoparticles of chromium, cobalt and molybdenum, that blood serum testing did not reveal the problem, but that increased DNA mutation in the bone marrow and brain, as well as a Th1 driven immune hypersensitivity, that could eventually be linked to autoimmune disorder, was apparent.

Heavy metal nanoparticles have been a focus of study of cytotoxicity long before the warnings from metal-on-metal hip prostheses, and the evidence shows that metal oxide nanoparticles cause significant damage to mitochondrial function and DNA, as well a cytotoxicity and inflammation in vascular endothelial cells. A 2015 study at the University of Rochester, Department of Environmental Medicine, showed that the greatest risk from metal-on-metal hip prosthetics is the accumulation of chromium oxide nanoparticles (PMID: 25744761). A 2014 study at the University of Stathclyde, Glasgow, United Kingdom, studied the effects of chromium oxide nanoparticles on lymphocytes, and found that these cytotoxic nanoparticles from metal hip replacements induced cell apoptosis, lymphocyte proliferation, increase in inflammatory cytokines, and impairment of immune regulation (PMID: 25612073). Studies of techniques to clear this heavy metal toxicity from hip prosthetics have found that activated charcoal and a variety of chelating chemicals are mildly effective.

Assessing the long term outcomes of total knee prosthetic replacement

Because of the amount of research data in the last decade that has cast a discouraging light on surgical repair of degenerative knee joints when used alone, and the continued reluctance to utilize an integrated conservative approach to healthy restoration of knee joint tissues, many orthopedic specialists have turned to total knee prosthetic replacement as the treatment of choice. Many patients report that the advice given is to wait until the knee is degenerated enough to warrant total knee replacement, since there is no standard therapy that will restore degenerated cartilage and meniscus, especially when there is evidence of arthritic disease. This article presents research that shows that a number of therapeutic protocols are now proven to aid regeneration of cartilage. Patients are also led to believe that the total knee prosthetic replacement will result in a pain free functional state without significant complications. Often times, the long term outcomes presented by the surgeon are overly optimistic. Long term outcome data is still relatively scarce, but the federal government has released some analysis of early long term studies as part of the AHRG (Agency for Healthcare Research and Quality), a mandated part of the U.S. Department of Health and Human Services.

The AHRQ Total Knee Replacement Summary (No. 86) reports that total knee arthroplasty (prosthetic replacement) is now one of the most common orthopaedic procedures performed. The AHRQ states that although previous industry reports were very positive, that "based on conclusions from consensus panels or surveys of health care providers, there is considerable disagreement about the indications for the procedure." This means that some surgeons may advise a patient to have a total knee prosthetic replacement, while other surgeons may advise that the particular case does not warrant the knee replacement when considering other options, and weighing risks versus benefits. The AHRQ report does report a good rate of success for the procedure, although, when looking closer at the data, there are troubling questions that arise. Since total knee replacement is a relatively new procedure, and the patient wants the knee to perform without problems for the rest of their life, we look to long term study data to help us decide whether the knee replacement will eventually present serious problems. Unfortunately, the AHRQ meta-analysis only considered literature data from standard medical journals up to 2003. Advances in design, and favorable industry reports, have produced a dramatic increase in the number of total knee replacement arthroplasties since 1997. The industry itself still relies on the most favorable study of long term outcome, the 1994 Ranawat study, which reported a 95.6% success at a 14-year follow-up. Dr. Chitranjan Ranawat heads Ranawat Orthopaedics at a hospital in New York that specializes in total arthroplastic surgery, called the Hospital for Special Surgery, and the report is a study of the total knee arthroplasties performed at this prestigious hospital. In many, or most, cases, the knee replacement does not last anywhere near this rosy picture of 14 years. In fact, in 2010, a new type of artificial hip designed to last 15 years or more, was found to fail at an unusually high failure rate after just a few years due to a relatively rapid degeneration of the tissue to which the orthotic attaches. Unlike new drugs, medical implants and devices can be introduced to the market without long-term clinical trials if they resemble a device or implant already approved. To see a New York Times article on this subject, click here: http://www.nytimes.com/2010/12/17/business/17hip.html?_r=1

The AHRQ meta-analysis up to 2003 reports that the median age for total knee arthroplasty was 70 years of age, and 2/3 of the patients in clinical studies were women, with about 1/3 considered obese. About 90% of the participants in the studies had been diagnosed with osteoarthritis. In the studies, 0-56% of the patients receiving the procedure for the first time did not participate to completion of the study. The studies followed patients for between 45 and 67 months (about 4 to 5.5 years). The studies noted that when considering the baseline knees (those not receiving total knee arthroplasty) that the length of follow-up was between 68 to 90 months. The AHRQ panel recommendation, though, suggested a 10 year follow-up, and this is the source of much criticism of industry studies. Of surviving patients, there is a high rate of a need for a second total knee replacement by the sixth or seventh year, and due to degeneration of the tissues surrounding the prosthetic, and the risks of the surgery for patients over 80 years of age, a third total knee replacement is not considered viable as a general guideline. This means that in consideration of total knee arthroplasty, the patient must consider general time of good function and pain relief provided. The patient must also consider that there is a lengthy period of recovery and rehabilitation needed after the first total knee replacement, usually involving considerable pain. Often, the outcomes for this procedure are good after the first year, but by the sixth or seventh year, the prosthetic and attaching tissue are again severely degenerated. The AHRQ study shows that the industry has evaluated this optimal window, and failed to provide data for the time when many, if not most, of these prosthetic procedures fail.

The AHRQ meta-analysis also reports that there is a surgical complication rate within 6 months of surgery of 7.6% of total patients. Anti-coagulant drug therapy was the treatment of choice to prevent deep vein thromboses, despite positive findings for techniques of continuous passive motion and other mechanical means of treatment, which would have a far lower risk of side effects and risks. Failure of the prosthetics over time is expected in many cases, and the number of total knee arthroplasty replacements was high through 2003. The ARHRQ study found that within the five year study time, only about 2% of patients needed a second total knee replacement, but there was insufficient data in the industry studies to assess the number after 5 years, when the first knee replacement is expected to fail. Following the second total knee replacement the AHRQ meta-analysis found that the global knee score (standard measure of pain and function) was about 66 to 80 following this procedure, on average. The AHRQ states that there is no formal basis for translating the size of scores, and that the industry only looks at improvement over pre-operative state, but that a generally accepted rule of thumb is that a score of less than 60 is considered poor, and a score between 60 and 69 represents a fair score (85-100 is considered excellent). The pre-operative scores for these patients ranged from an average of 35.4 to 51.5, indicating that these patients experienced considerable pain and dysfunction. Complications following the second knee replacement in the meta-analysis occurred in 26.3 % of the patients, although only 12.9% of these complications involved the knee, meaning that 13.4% of patients had other health complications after the surgery.

What the AHRQ meta-analysis of knee replacement up to 2003 shows is that within a time frame of 5 years, the surgery is very successful for the 50% of patients studied that did not drop out of the study or die during the study period. No analysis of the percentage of patients needing a second total knee replacement after 5 years was available. Post-operative complications with the first total knee replacement occurred in 7.6% of the knee replacements, with the vast majority involving deep vein thrombosis, which involves considerable risk of stroke or heart attack. Post-operative complications in total with the second total knee replacement occurred in 26.3% of patients, with about half of these health problems occurring in the rest of the body besides the knee. Standard assessment of pain and function showed that the patients generally obtained a poor to good range after the second knee replacement. Study data in the AHRQ meta-analysis was apparently insufficient to rate the actual pain and functional status following the first knee replacement within the first 5 years, but the report states that a "mean effect size" was considered large in magnitude and varied from 1.3 to 3.9 depending on the means of measuring the functional state and duration of followup. Of course, to the general public, this is incomprehensible. The term "mean effect size" refers to an average of the variety of measures of treatment effect, which are combined to calculate treatment success according to a statistical method that is chosen. The British Medical Journal states in its explanation of clinical evidence regarding the use of a mean effect size: "we avoid if possible. Standardized mean differences are very difficult for non-statisticians to interpret and combining heterogenous scales provides statistical accuracy at the expense of clinical intelligibility. We prefer results reported qualitatively to reliance on effect sizes." In other words, the AHRQ report does not give the patient much real information to actually assess the pain and functional results of this surgery even within the optimal 5 year life of the prosthetic. To review this AHRQ meta-analysis, click here: http://www.ahrq.gov/clinic/epcsums/kneesum.htm

A 2010 meta-analysis in Europe, conducted by the WHO Collaborating Center for Public Health Aspects of Osteoarticular Diseases at the University of Liege, Belgium, also found that 74 studies met their criteria between 1994 and 2003, but that only 16 focused on total knee arthroplasty exclusively, and that the duration of follow-up ranged from 7 days to 7 years, with the majority describing results at 6-12 months. These small number of studies worldwide reported excellent outcomes within this optimal time frame. No studies were found that gave the patients and physicians data on the outcome past the expected life span of the prosthetics, which is generally accepted to be about 6-7 years with the first knee replacement. The study found that men seemed to benefit more than women, and that when improvement was found to be only modest, the researchers emphasized the role of comorbidities, or other health problems. The success of total knee replacement was found to exceed the success of other knee surgeries of standard procedures, which as mentioned above, did not fair so well in large studies in the long term. No studies are available to compare the success of conservative protocols to the total knee replacement. Apparently, no studies of outcomes after 2003 are available as well.

By 2015, various studies showed a wide variance in long-term outcomes with both knee and hip total arthroplasty (prostheses). A study by the University of Michigan Health System noted that patients who scored higher on a fibromyalgia survey, assessing anxiety, depression, pain sensation, function, catastrophizing and comorbid symptoms associated with fibromyalgia experienced poorer long-term outcomes after receiving prosthetic joints (PMID: 25772388). A long-term study of men under the age of 55 who underwent total knee arthroplasty, by the University of Pennsylvania and the Insall Scott Kelly Institute in New York, showed that these early recipients of a relatively young age showed a 30-year survivability without revision of 70 percent (PMID: 25232089), but clinical evaluation was only available for 36 or 114 total patients. These statistics of the best early knee prostheses and model clinic in New York showed a positive outcome for the 70 percent that were still living. The odds of long-term success were good if one was a betting person. For those patients that definitively needed total knee arthroplasty, and whose chance of functional improvement in knee health was poor, this is good news. The choice, though, still comes down to whether there is a good chance of healthy rehabilitation of the degenerative knee.

The patient must make a choice of going through a total knee replacement based upon incomplete and unclear industry study so far. These studies do summarize the procedures as highly successful. Many patients, though, are considering this scenario and exploring ways to utilize conservative care, mainly with Complementary Medicine, to try to reverse joint degeneration, or slow it, to avoid or delay the need for total knee replacement. Another consideration is the integration of conservative therapies after a total knee replacement, which could potentially speed recovery, increase functional improvement, and prolong the health of the tissues around the prosthetic to delay the time when a second total knee replacement may be needed. If opting for use of Complementary Medicine before the need for the first total knee replacement, a large number of scientific studies now demonstrate proof that various strategies may result in growth of healthy cartilage and joint tissues. When considering a conservative treatment protocol, the patient should look to combine a sensible array of these therapies in a package of care. The choice of just trying one type of therapeutic intervention at a time is a prescription for failure. An intelligent combination of therapies within a protocol is the wise choice, and the patient should try to find the most knowledgable Complementary Medicine physician with an array of treatment skills to deliver this protocol. Combining physiotherapies, such as soft tissue mobilization and myofascial release, with acupuncture, electrical stimulation, evidence-based herbal and nutrient medicines, and patient instruction in self-administered therapies, such as postural and gait correction, and targeted stretch and exercise, is the formula for success.