16. Arthroplasty Registries: Quantifying Your Revised Knee Experience

Check boxBlog 15 walked us through some of the issues defective joint replacement devices cause and the nefarious role the U.S. FDA’s Fast-Track System plays in bringing implants to market, worldwide, without the benefit of rigorous clinical studies to test their safety and effectiveness. I implored you to do what I did not: know your own make and model so that you can more effectively troubleshoot its weaknesses.  Blog 15 concluded with a list of baseline questions to ask your surgeon before agreeing to a revision knee surgery, having determined, unequivocally, that knowing more about your knee implant than less protects you as best as possible, given that we cannot know exactly how well a device will function until it is in you. But we can also do better at tracking knee implants and their after-shocks than we have in the past.

Let’s clarify:  the ideal revised knee replacement implant will allow for baseline normal activities such as walking some blocks to and from the grocer’s and then putting away the groceries; normal motion such as sitting, getting up, turning around while holding something, or carrying a  (light) basket of laundry. They are not designed to enable you to return full force to contact or high-impact sports. Hypothetically, a revised knee replacement, with significant lifestyle modifications, might or could last a patient’s lifetime, if you are in your late 60’s or 70’s. Right now, younger recipients have more demand on them to adapt more careful lifestyles, to pace themselves even more carefully and acquire the grace to do so in order to side-step depression.  So, additional factors besides make and model of a new device also determines the success of a revised knee implant: body structure (ergonomics), pre-existing physical and bio-chemical conditions, and degree of physical discipline by the patient – these along with access to support services and a manageable home environment, financial (flexible employment) and food security, ready access to family and friends, and to consistent physical therapy: these and probably more contribute to positive, long-term outcomes.

So too does having a tool that collects and assesses the strengths, weaknesses and problems associated with implants, the surgical methods used to secure them into bodies, and the rehabilitation programs supporting the recipient. That tool is oftentimes called a Joint Replacement Registry and relies on quantifiable input from surgeons and patients.  It was Sweden that, in 1975, established the world’s first database registry. Now there are well over 35 different registries worldwide designed with the same aim: to provide evidence-based information to guide physicians and patient’s decision-making, and to improve follow-up care, implant design, and surgical techniques. Or, as the American Joint Replacement Registry succinctly put it: To Improve Orthopedic Care Through Data.

AJRR photo coverThe American Joint Replacement Registry (AJRR) has grown to be the world’s largest registry of hip and knee replacement data by annual procedural count. As of November 1, 2019, the Registry contains data on over 1.8 million procedures from hospitals, ambulatory surgery centers (ASCs), and private practice groups in all 50 states and the District of Columbia, to date. It will also need to accommodate increasing numbers of Total Knee Replacement procedures and their associated Revision procedures.  By 2030, The American Association of Orthopedic Surgeons anticipates an additional 120,000 revision procedures alone. That is a jaw-dropping 190 percent increase from 2019.  Unless Regenerative Medicine offers alternatives to metal on bone procedures soon, these numbers will more than double by 2060 (when Revisions are expected to number 253,000, a 400 percent increase from 2019).  These are numbers we do not need to be proud of.  They do not strictly represent improvements in joint repairs, but how market-driven the American culture of orthopedic health care is to combat bone problems quickly with intrusive metal solutions that do not always ensure safe short-term or long-term successes, especially for revision recipients.

But the capacity of the Registry is helpful.  The AJRR is able to search within its inputted data, run reports, and compare a hospital or clinic’s performance to national benchmarks. It also allows surgeons to develop personalized dashboards to summarize their own procedural, post-operative, and patient care data so they can compare their own performances against national benchmarks.

Miller-survey-completing-form

For those of us living in countries with such registries their value is as strong as the data inputted. I encourage you to determine, before you have surgery, if your surgeon participates in a Joint Replacement Registry. If not, keep searching for a surgeon who does. Once you find her, familiarize yourselves with the patient reported outcome measurement (PROM) tools of the registry available to you. In the case of the American Joint Replacement Registry three patient-focused assessment tools are primarily depended on:

  1. PROMIS-10 GLOBAL assessment tool: This tool was designed to be a “bottom-line” assessment of a patient’s health used for a wide variety of diseases. Is it sufficient for assessing the complexity of a person’s life? Yes and No. Filling out the form as instructed dutifully informs the Registry. But its generalized questions require you to summarize what can be conflicting and contradictory information during your post-surgery follow-up. More on this below.

The PROMIS-10 GLOBAL tool is free and accessible at this site:                    http://www.orthotoolkit.com/promis-10. You can probably even pick one up at your surgeon’s office. Note that you can also complete the assessment online as well as print off an empty one and fill it in with a pen or pencil.

  1. Knee Injury and Osteoarthritic Survey (KOOS): KOOS asks for information specifically about your knee (a similar survey focuses on hips, called HOOS). It strives to capture both your physical and personal experiences adjusting to a damaged knee. Unlike the PROMIS-10 GLOBAL assessment tool, KOOS tries to accommodate changes patients make in their lives to accommodate a damaged or a healing knee joint. Like the PROMIS-10 GLOBAL tool, it does not offer the patient space to clarify or describe exceptions or additional factors informing the generalized answers. KOOS offers long and short forms of Knee Injury and Osteoarthritis Score survey.  They are free and easy to access: koos.nu/koos-english.pdf  and www.physio-pedia.com/Knee_Injury_and_Osteoarthritis_Outcome_Score.
  1. Veterans Rand or VR-12: The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social-functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents’ physical and psychological health status before and after the surgery. Take a look at this tool at aaos.org/uploadedFiles/Veterans%20RAND%2012%20(VR-12).pdf (Some Registries may link and blend this tool’s scores with the PROMIS-10 GLOBAL above).

Do these patient centered tools capture all the important factors impacting knee revision surgery?

They try. It is important to honor the efforts of the Registries. Without them, we would be riding roughshod into the wild west of joint experimentation while relying only on advertisements to guide us. But it is also important to recognize the limitations of the Registry.  Some hospitals and clinics offer their own cocktails of questionnaires, or none at all: When prepping for my revision surgery in Italy, I received a KOOS but not a PROMIS-10 GLOBAL. For follow-up in Bangkok, I did not fill out any patient assessment form. In the USA, these three patient-centered tools are typically given in tandem but not by all surgeons, hospitals, clinics, and post-surgical centers since participating in the American Joint Replacement Registry is voluntary.

Native-Graph-Database

Keep in mind that the trauma generated by a revision knee surgery and the associated medications taken afterwards can easily cloud our ability to recall details. And, since these assessment tools force us to check boxes, they do not include space for patients to add additional text to clarify or detail exactly how or why they answer what they answer. I suggest creating your own space on each assessment and jotting down your pertinent details. By doing this, and keeping copies of your own self-assessments, you can gauge how you are doing before and after your knee replacement without forgetting important facts. Complete an assessment before each doctors’ visit. That way you can remember to articulate what is important to you while also helping your surgeon inform the Registry with information important to your surgery and to your repair.

Keeping copies of your assessments can also be very helpful to your physical therapy center for determining specific exercise protocols tailored to your specific needs rather than to a generalized schedule for all implant recipients, as is often the case in the USA.  This practice may be particularly useful if your therapy center depends on rotating therapists in and out of your sessions.

Keeping copies of your assessments can also help inform your legal team should you need to pursue medical malfeasance (See Blog #15).

The PROMIS-10 GLOBAL, highly relied on by the AJRR, seeks general answers to general questions. Take for example question 7c asking for your level of pain, ‘in general’.  We know that pain shifts from hour to hour and depends on our recent physical activity. It also can be chronic or acute depending on activity, weather, or amplified if pre-existing medical conditions exist such as lupus, osteoporosis, or varicose veins. We also know that pain can be shielded by taking anti-inflammatories. Yet, while the surgeon’s AJRR assessment tool includes identifying pre-existing conditions, none of the patient-oriented assessments asks you how you think those conditions affect your healing.  They also do not ask how often you ingest pain killers. So, to answer how, in general, is your level of pain, you must compress or select the facts, skewing your answer away from full representation of your experience.

Be aware that the KOOS and PROMIS-10 GLOBAL are designed to be complementary but without details from patients, completing one without the other eclipses gathering useful data.  For example, The PROMIS-10 GLOBAL Question #5 asks: In general, how would you rate your satisfaction with your social activities and relationships?  Select: ‘Poor’, ‘Fair’, ‘Good’, ‘Very Good’, Excellent’. The KOOS asks in Q2: Have you modified your lifestyle to avoid potentially damaging activities to your knee(s)?  Select: ‘Not at all’, ‘Moderately’, ‘Severely’, or ‘Totally’. They both try for important data that happen to be codependent, but the details are sacrificed for the ability to check a box.

Hmm…

When I answered the PROMIS-10 GLOBAL with a 4+ (out of 5) and without the benefit of completing a KOOS form, I was in a perky mood because I recently had a social outing and I had just been notified that a piece I wrote was going to be published, so I was feeling very good, ‘in general’.  To give that high ranking I compressed all my actual compensation techniques for managing the ongoing pain the revised knee implant had forcibly created. As an extrovert, I returned to more introverted, singular activities in the confines of my own home so I would not have to challenge the knee more than I should: I invested in more online exchanges rather than meeting in person. I strategized how to use (and pay for) various forms of transportation to get from point A to point B, with plenty of days in between to recover from those trips. I regularly swallowed two, 500 mgs. of Tylenol, sometimes more, to get up and go during the first year following surgery and incorporated more applied ice routines and meditation periods into my daily life. So yes, I gave a positive answer despite the machinations I went through to maintain a healthy lifestyle.  The answer did not reflect the success of the surgery itself but of my capacity to adapt.

Rebotec-Crutch-Strap-Kitchen

The revised knee continues to cause problems two years after surgery. But there are no questions in the PROMIS-10 GLOBAL asking about personal resiliency and access to additional resources to adapt.  I swear my Zimmer Biomet NextGen Revision Knee System has a lateral plateau issue. Yet there are no questions asking patients for specific information about where in the joint they experience ongoing pain. I am hard pressed to see how the questions asked by the PROMIS -10 assessment tool communicates strengths and weaknesses of the implant device itself.  How does our (patient) input inform and then influence the design of a device, we ourselves host, if we are not asked direct questions about our experiences with the metal? That I must ask that question raises my concern: what kind of  specific, patient-informed quality-control assessment is used to inform implant designers and their manufacturers? If available, where are they located? As recipients, our ability to communicate to implant device manufactures our experiences of their makes and models is valuable – especially as we continue to serve as guinea pigs.

Without the opportunity for patients to provide full answers to more probing questions, the assessment tools together and separately are inadequate for the purposes of truly ‘improving orthopedic care through data’.  Yet, the responsibility for communicating the realities of our lives to our health care team, and thus the orthopedic industry, is on us, the patients, to ensure complete consideration of the range of effects revision surgeries have on our lives.

However, even if your revision experience is replaced by a numerical figure to communicate your views, your views can matter.  As the AJRR Annual Report 2019 stated, no matter how presumptuously: “Patient Reported Outcome Measurements (PROMs)…are increasingly being utilized to evaluate success of a hip or knee arthroplasty procedure. Many orthopedic stakeholders are finding benefit in capturing this patient perspective to best provide a full picture for surgical outcome evaluation. Recognizing this, AJRR has made a commitment to facilitating capture of this useful data.” Let us help health care providers, manufacturers, and future patients by taking the 5-10 additional minutes needed to complete these summaries by insisting on adding our own clear, raw, therefore important, data.

Other Suggestions to Improve Current Assessment Tools

I am not a statistician nor a physician, but I have been an active patient over the years.  It seems to me that the existing assessment tools, while helpful, could be ‘tweaked’:

  • Assessments are taken within a shorter window of time than the length of dependency on the implant itself. My doctor stopped interviewing me approximately one year after my revision surgery. The worldwide orthopedic industry acknowledges the complexity, no, the severity, of revision surgeries. So, why does the industry stop collecting data after one-year? Two years out from my last surgery, and I am still feeling the effects of this irreversible situation. Why is the registry not formally designed to capture on-going data from this quickly expanding arm of the orthopedic industry?
  • Assessment outcomes are selectively used and communicated. Patient input materials while noted as important do not seem to factor high in the final annual report by the AJRR (2019). For example, to date, the AJRR does not incorporate PROM mental health care outcomes but they are quick to point out the rising numbers of patients ‘satisfied’ with their overall surgical outcome.
  • Assessments are limited in scope. The Revision Arthroplasty Section of the Report does not ask and therefore analyze how pre-existing conditions such as established scar tissue, autoimmune diseases, or osteoporosis impact outcomes.
  • Input from surgeons could be biased. How are surgeon inputs assessed for possible bias in favor of successful surgery outcomes?  It is very possible that doctors skew their input into the Registries to reflect only positive outcomes for themselves or only input negative outcomes due to implant design rather than to dubious surgical procedures.
  • Data is available to patients but you have to look for it.  Go to the AJRR Blog site to initiate ongoing contact with the Registry.  You can even request weekly or monthly updates and input your own responses.  The site: blog.ajrr.net/joint-surgeon-needed-tka . If you want to know the outcomes of your time and effort filling out PROMs, you really must search for their generalized outcomes. And, for now, as recommended above, you must keep your own records and expand on them if you want to keep an accessible ongoing record of your implant experience.
  • Registry guidance is limited. While (for example, the American) Registries are supported by committees that sometimes allow one or two patients to sit on them, globalization of this industry screams for broader patient representation by age, range of implant types, bio-regions, and income-levels.

Are these assessments enough to protect us from medically deficient devices or incapable surgeons? No. We still do not have enough data to determine the best knee replacement implant for someone’s structure.  A surgeon will still favor a familiar make and model, hospitals who purchase the implants will favor cost-effective investments, and fast-tracked devices will still find their way into our bodies unless quickly taken off the market. And, unless a company is sued, (i.e. Zimmer-Biomet, see Blog 15) such devices will more than likely remain on the market for quite some time.

Still, until reliable and less invasive means of managing damaged knee joints are readily available, implants and their associated registries are almost all we have for tracking joint repairs. Let’s make the most of them.

Dr and PT good

BLOG 17, the third in my three-part series, will explore Patient Advocacy Groups and their efforts to help improve knee implant care.

 

RESOURCES for BLOG 16:

American Joint Replacement Registry: aaos.org/registries/registry-program/american-joint-replacement-registry/

Annual Report, AJRR, 2019: connect.ajrr.net/2019-ajrr-annual-report

www.isarhome.org/

www.verywellhealth.com/what-type-of-knee-replacement-implant-is-best-2549614

blog.ajrr.net/public-advisory-board-charter-expands-from-ajrr-to-aaos-registry-program

http://www.FDA.gov/medical devices

www.orthotoolkit.com/promis-10

www.koos.nu/koos-english.pdf

www.physio-pedia.com/Knee_Injury_and_Osteoarthritis_Outcome_Score

www5.aaos.org/uploadedFiles/Veterans%20RAND%2012%20(VR-12).pdf

www. aaos-annualmeeting-presskit.org/2018/research-news/sloan_tjr/

15. Is It True That What You Don’t Know Can’t Hurt You?

Strap in. This is the first of three posts dedicated to medical device research, global database practices, U.S. FDA approval procedures and pending legislative Bills impacting quality controls over knee replacement devices and their paths to market.

roma

My friend Lindsay and I were having a happy hour one fine fall day and were comparing our experiences with orthopedic surgeons.  I became particularly agitated when I began describing my first meeting with a joint replacement specialist to discuss revising my old Total Knee Replacement (TKR).  I can still remember my frustration: “He had the temerity to ask me what the make and model of my first knee replacement was! That was fourteen years ago!  I hardly remember – and truth be told, it didn’t occur to me to even ask the surgeon back then about make and model. I mean, what kind of expertise could I lend to decision making about a knee model and type?  I depend on the surgeon to make that kind of decision. The fact is, I also lost the records in all the moves we made since then and I can’t even guess what kind of knee I have holding me up. I just know it is metal.”  Lindsay’s attentive, quiet stance told me I was being heard but her coy smile told me she had a different perspective that I paraphrase here:  “You know luv (she is British), that was precisely the first question we asked our surgeon when my husband’s hip had to be replaced: what kind of model, what type of metal and what year of manufacture? I then did my best to research as much as I could about it. Yah! We have all the records about that surgery.” That was a coarse moment, made memorable by the humility, the stupidity that I felt and continue to, because in this case, clearly, what you don’t know CAN hurt you.

The revered Consumer Reports (www.consumer reports.org) agrees with Lindsay. When considering an implant, they recommend these steps, 1) Select an experienced surgeon. 2) Research the ‘Recall’ history of the implant device after selecting a make and model. 2a) Establish a record of your research to have on hand ‘just in case’. 3) Discuss pain treatment plans.

components

What is ‘Recall’ History and Why is Knowing an Implant Recall History Important?

The recall of a medical device is a term used by the United States Food and Drug Administration (FDA) to describe what, why and how often a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. (www.fda.gov/medical-devices)

The FDA website goes on to explain that a medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a revision knee) is recalled, it does not always have to be explanted (removed) from patients. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

Examples of the types of actions that may be considered FDA recalls:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings on the device
  • Re-labeling the device
  • Destroying the device
  • Notifying patients of a problem
  • Monitoring patients for health issues

Sometimes a company may be aware that there is a problem with a group of products, but it cannot predict which individual devices will be affected. To appropriately address the concern, the company may recall an entire lot, model, or product line.

Who Recalls Medical Devices?

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:

  • Initiates a recall (through correction or removal)
  • Notifies the FDA.

Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, the FDA has rarely needed to require a medical device recall (www.fda.gov/medical-devices).

What Does the FDA Do About Medical Device Recalls?

When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem violates FDA law, offers potential violations of FDA requirements, and if appropriate, assigns the recall a classification (I, II, or III) to indicate the relative degree of risk.

Class I (high risk): A situation where there is a reasonable chance that a product will cause serious health problems or death (i.e. pacemakers).

Class II (medium risk): A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death. Joint implants are commonly found in this category.

Class III (low risk): A situation where a product is not likely to cause any health problem or injury (i.e. scalpels, bandages).

Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall.

How does the FDA Notify the Public about Medical Device Recalls?

When a company initiates a correction or removal action, the FDA posts information about the action in the Medical Device Recall Database. (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm)  This is the site you want to visit when you learn the name of the make and model your surgeon recommends. It is also a site you can visit as you explore for yourself, makes and models you think could be best suited for you.

The FDA updates the Medical Device Recall Database after it classifies the recall and again after it terminates the recall.

In addition, the FDA may post company press releases or other public notices about recalls, market withdrawals, and safety alerts that may potentially present significant risks to consumers or users of the product.

After a recall has been classified, the FDA notifies the public in its Weekly Enforcement Report. In addition, the FDA posts consumer information about recalls  in order to ensure that patients are aware of the seriousness of the potential health hazard posed by exposure to the product.

Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall (www.fda.gov/medical-devices).

This all seems clear and accountable. What’s the problem? 

Being able to quickly bring an implant device to market while avoiding previously required rigorous clinical studies – that is the problem.  The advocacy group Consumers Union (within Consumer Reports) reviewed the FDA’s medical device database and found that 708 knee replacement recalls were issued between 2003 and 2018. Drugwatch conducted a separate review in 2018 and identified another 76 recalls. Roughly 97 percent of all recalls in 2018 involved knee replacements from just three manufacturers: Zimmer-Biomet, DePuy and Stryker. (www.drugwatch.com/knee-replacement/recalls/)

Announcing a recall is one step. The actual number of components and patients affected are exponentially more.  For example, in 2010, the U.S. FDA issued a Class II recall to Zimmer Inc. (now Zimmer Biomet) for its NexGen Complete Knee Solution MIS Tibial Components, Locking Screw and Stem Extensions, affecting 68,383 devices that had already been implanted. In addition to this recall, the company issued a voluntary recall on an additional 41,180 devices. Al tol, two recalls, one forced and one voluntary, affected over 100K devices of which over half were already implanted in people knees and thus, into their daily lives. (www.lawsuitsettlementnews.com/defective-product/zimmer-nexgen-knee)

How Did This Happen?

The FDA established the FDA 501 (k) 3 Clearance Process which allows the fast-tracking into a surgeon’s office new implant designs that are deemed “substantially similar” to previously approved models.  This fast-track allows devices to avoid undergoing what would have been typical but time consuming and rigorous clinical testing.  As Jeanne Lenzer (Gloopman, The New Yorker, April 2020) explains, most (i.e. Class II) devices are “exempt from clearance or approval and can simply be registered with the FDA” (through the 501 (k) 3 Clearance Process); more invasive or complex devices in these classes also face minimal hurdles, requiring only that a manufacturer give the FDA ninety days’ advance notice before marketing a device. Unlike drugs, these items do not need to be tested in clinical trials, and they are said to be “cleared” rather than “approved.”

Reality can be harsh: Under the FDA Fast-Track System, patients become the research subjects. Patient use and feedback on recover (aka of a make and model) creates the ‘clinical study’. My, your, our feedback provides the data and marketing language.  In addition, you and your insurance company pay for a company to improve its products while you risk suffering the consequences of hosting a defective device.

Still, the FDA 501(k) 3 clearance process still actively exists despite rendering “…thousands who receive (implants) (to) serve as unofficial test subjects.” (SurgicalWatch.com). A growing percentage of this group suffer the unacceptable consequences of chronic pain, immobility and a premature need for revision surgery – and so goes the reality of revision repair as this blog site has been describing.

A quick overview (DrugWatch.com) of the leading lawsuits to date showcases how people are truly suffering from fast-tracked models that have not completed slower paced, rigorous clinical studies reliant on the combination of computer simulations and alternative test subject (i.e. dogs):

Manufacturers, Models, Problems

Arthrex, iBalanced Knee, Loosening/defective tibial tray

B. Braun, Adv. Surface Ceramic Coated Knees, Loosening/cement failure

DePuy, Attune Knee System, Loosening/ Instability

Exactech, Optetrack Knee, Excessive wear/premature failure

Zimmer Biomet, NexGen, Premature loosening

Zimmer Biomet, Persona, Loosening/Defective screws

Stryker, Duracon Uni. Knee System, Pain/Instability/Limited ROM

WHAT YOU DON’T KNOW CAN HURT YOU.

Much, much to my chagrin, my revised knee structure is the Zimmer Biomet NexGen system – a zippy, wow name that would appeal to me if I didn’t know any better.  It was first introduced in 1995, with most of its components later approved, without extensive trials thanks to the 510K fast-track approval program.  How difficult it was to learn that this make and model of implant is prone to fail within a few years. Needless to say that as (and still) the most popular design on the market, Zimmer Biomet faces the largest lawsuit on record for knee replacements. (www.aboutlawsuits.com/zimmer-nexgen-knee-settlement-140107/ )

What Could I Have Done Differently?

 I could have asked my surgeon these questions among others:

  • What device are you planning to use?
  • Why this device?
  • Does it have a reasonable track record of use (minimum of 5-10 years) (verywellhealth.com/what-type-of-knee-replacement-implant-is-best-2549614)
  • How often have you implanted this device?
  • Given my age, medical profile, lifestyle, resilience capacities, and future needs, describe how this device appropriate for me?
  • What is its recall history and why?
  • How do you square its recall history with your reliance on it now?
  • What database(s) do you rely on to determine which implant device to use?  (more on this in Blog 16)
  • What do your previous patients think are this device’s strengths and weaknesses?
  • May I talk to ( i.e. three of) your patients who have the same device?
  • What are some decent alternatives? What are their strengths and weaknesses?
  • If I wait, what device improvements might be ‘just around the corner’?

Asking any combination of these questions could have also helped me assess more astutely, no, responsibly, if this surgeon was as good as hi/her website testimonies, research papers and hospital rates claimed and clarified if s/he was a good match for me?

I could have embarked, from the start, on a physical therapy routine that factored in the weaknesses of the make and model.  Recently, I redesigned some of my PT routines now that I know I live with a vulnerable device. I have accepted that I must regulate my getting up and sitting down, amount of walking, avoidance of stairs and sudden movements.

In the meantime, I now do have a resource file that I update periodically with information pertinent to my make and model. I use a very green neon tab.

I continue to take deep breaths when I feel despair crawling out from under the metal. I consciously tamper it down into a low-grade awareness and return to core muscle exercises. I also returned to doing shoulder-stands, thus shifting stress from my knees to my shoulders where the weight of responsibility more ably rests.

sarvangasana

WHAT YOU DON’T KNOW CAN HURT YOU. WHAT YOU DO KNOW CAN ONLY EMPOWER YOU. 

Blogs #16-17 will review how newer databases are improving information gathering on currently implanted devices, and on current legislative Bills to secure patient safety and close the FDA 501 (k) 3 Fast Track loopholes.

Blog #15 resources:

Lindsay T.; Rome, Italy/Manchester, England

www.consumerreports.org/joint-replacement/what-you-must-know-about-joint-replacement/

www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

www.newyorker.com/magazine/2020/04/20/do-some-surgical-implants-do-more-harm-than-good

www.surgicalwatch.org

www.aboutlawsuits.com/zimmer-nexgen-knee-settlement-140107/

www.surgicalwatch.com/category/knee-replacements/

www.drugwatch.com/knee-replacement/lawsuits/

www.lawsuitsettlementnews.com/defective-product/zimmer-nexgen-knee/

www.verywellhealth.com/what-type-of-knee-replacement-implant-is-best-2549614

Pausing to Celebrate!

Experdido Insignia

Occasionally, being recognized for excellence changes the light in a room.  I was recently informed that an online assessment site called expertido.org reviewed 105 blog sites dedicated to knee replacement issues and selected 21 to receive their star of approval. A team of four analysts used five core criteria including ease of study, design, user interface, and consumer confidentiality as well as how it appears on social media. For more information go to  www.expertido.org/best-knee-replacement-blogs-reviews/

Thank you expertido.org for recognizing Revised Knee, Revised Life!

In addition, Revised Knee, Revised Life was recently ranked as one of the top 50 blogsites for Knee Surgeons and for Knee Patients by FEEDSPOT for 2020.  What an honor to sit among many informative and helpful sites.

Take a look at FEEDSPOT’s full list of winning sites: blog.feedspot.com/knee_blogs/

While these are not accolades I envisioned achieving in my lifetime, I am glad the blog is of service for those who end up on this unique journey. I look forward to adding more articles, adding more comments and seeing more clicks to ‘follow’, in hopes that you can also pass it on to those in need.

Thank you.

 

14. Pain Management in a Box: The Magic of Kinesiology Tape

Last month, I spent a good portion of my time researching the pros and cons of leg amputation. No joke. My revised (left) knee was killing me with daily pain starting back in November 2019 when I was becoming more actively engaged in work, social times, and those occasional shopping moments required to feel good about limping.  Granted, I have a wounded knee, scarred by many operations (Blog #9). Between visiting websites on the pros and cons of amputation, I convinced myself that perhaps it was time to just live with pain. InkedAerial view AME_L2

But, this kind of pain attached to simple movements like standing, walking and getting up, cast a shadow on my mood and on my view about my rehabilitation over the last year and a half. I wanted out of this cycle and I wanted out quickly and finally– fed by a stalwart refusal to consider any more surgical or metal interventions into this knee already bionic and webbed with internal scar tissue and various external scars to prove it. I was truly in a state of despair.

I did my research on amputation, recovery and prosthetics.  It is not an easy subject to consider since it is not an easy procedure to heal from.  I knew I was courting extremes but living with chronic pain can lead to extremes. I prepared my list of issues to review with my orthopedic with this topic as the final discussion point. When I hobbled in, he ‘leaned in’ to listen but when I ended on the topic of amputation his audible gasp at the word stunned even me. He shook his head as he quietly declared that he would not broach the subject of amputation because I am far from needing it: only if my joint was bulging from infectious bacteria or shattered would he consider amputation as an option. But he fully agreed that x rays were required to review the status of the joint implant.

The x-rays proved that the joint was well embedded and in alignment. He surmised that scar tissue was inflaming the joint and that perhaps a few nerves were pinched in the process. He recommended that I see the pain specialist about a nerve block and possibly some narcotics to ease the pain.  It just so happened, the specialist was just down the hall. I plodded over and waited.  While waiting turned into an encampment period, my mind floated back to when I regularly worked with my PT who periodically massaged the joint and leg to move trapped lymphatic fluid, soften the scar tissue and ease the muscles.  She then applied kinesiology tape.  K-tape!  Of course! I jumped up as only my knee would allow, cancelled my appointment with the pain specialist and went home to do what I should have done from the start.  I massaged my own leg and then taped the joint. I then put the leg up while chastising myself for forgetting this simple step in pain management. 

tape scissors

my knee w tape 1

taped knee

How did I forget this simple self-care step? I thought I knew what I was doing, proven by having ‘graduated’ from needing regular visits with my PT.  Most importantly, the level of pain I was feeling led me to believe that it had to with the metal structure itself.  Instead, my chronic pain led to ‘drastic thinking’ (opting for an amputation meets the criteria for drastic thinking) rather than calmly reviewing methodical, step-by-step strategies for pain management including periodic PT visits, rest, massage, anti-inflammatories and K-tape.  With the help of K-tape, I was able to walk to the pool later that day and carefully complete my workout.  Later, I was able to make dinner, virtually pain free.  My husband and I celebrated with a gooey, wonderful mango sticky rice dessert.

Some simple pain management strategies can be hard to remember when your nerves are pinched, and your brain is spasmodically on high alert. I now find K-Tape extremely useful and on an infrequent basis to manage scar tissue pain and the lymphatic build-up caused by the stiffening of collagen fibers.

WHAT IS K-TAPE? 

It is a roll of stretchy spandex material that sticks as gently as painter’s tape but is almost as strong as duct tape. It is flexible, moving where and how you move, and it can last up to about 5 days in and out of water depending on how well curved you trim the tape edges ( for avoiding tugs), how vigorously you swim or how hot is the water.

K-tape is not to be confused with Athletic tape, which serves a different purpose and is a different product – and subject- altogether.

HOW CAN K-TAPE HELP REVISED KNEES?

In short, the PT and orthopedic communities agree that K-tape helps to:

  • Create balance in the neural circuitry in muscles, tendons, joints, and skin
  • Reduce pain, decrease swelling by improving circulation of lymphatic material
  • Improve muscle performance and function.

It is ironic that something so easy as tape can manage something so complicated as pain production. Pain sensations start with the aggravation of nociceptors found in our muscles, skin, and joint structures. This pain is then transmitted to our brain where our best and worst feelings, images, rationalizations, alert signals and decisions are generated. Importantly, decreasing nociceptor messages to the brain is believed to normalize muscular spasms, improve muscle tone, and thus minimize pain.  K-tape minimizes aggravation of the nociceptors – enabling us to think clearly and calmly about next step pain interventions, if needed.

Scar tissue management: Interior fibrous tissue, or collagen, binding to your skin and underlying fascia is inevitable after a revision procedure.  It is called scar tissue and most of our readers are intimately familiar with this difficult material.  The previous incision used to implant the original knee replacement is the same incision typically used to enter the joint to revise the implant.  Build up of scar tissue is inevitable for our lot and can, sometimes severally, limit normal mobility and range of motion. Kinesiology tape consistently and gently pulls on scar tissue, providing a low intensity and lengthy stretch to the tight collagen that makes up scar tissue, allowing for more flexibility.

Swelling management: K-Tape may help decrease swelling by decreasing pressure between the skin and underlying tissues. This provides a pathway for excess lymphatic fluids (accumulated through surgery or excessive exercise) to better circulate and, through osmosis, to disappear.

Facilitation: K-Tape is used to help improve muscular firing and contraction patterns, especially immediately after knee surgery. This can lead to normalized muscular tone and improved overall performance. Facilitation use is often relied on in the early stages of incision healing.  But for those of us with excessive scar tissue, use of K-tape can be extensive.  I have a dedicated drawer…though it is important to note that:

K-Tape is not intended to be used more than a few days at a time, and then infrequently.  If your pain persists after using K-tape, please consult your medical team.

HOW TO TAPE YOUR KNEE     

While a serious session on the subject with your PT is strongly recommended, instruction books are available and various video tapes offer clear visual tutorials. Here are just a few:

https://www.youtube.com/watch?v=v2xYUxXrjxk  I like their comprehensive description.

https://www.youtube.com/watch?v=R1m1WGUlZ8A  This shows the use of tape by physical therapists, immediately after a TKR.  The ‘Fan’ style could still have relevancy for you as it does for me. Consider fast forwarding to 2:21 onward.

www.verywellhealth.com/different-types-of-kinesiology-tape-2696483.  This provides examples of different cutting patterns to use for different issues.

knees

Caveat: Please consult with your PT first to determine suitable taping methods for your particular knee structure and for the type of pain you are experiencing. Some of you may have a partial knee replacement, or a torquing metal knee structure, and/or scars from previous procedures and/or various, sundry screws that may need to be considered when determining effective taping procedures.

AL TOL

The primary goals of revision knee replacement surgery it to correct the existing TKR joint itself, adjust for any alignment issues, reduce pain, manage infection and improve mobility. But as we heal, pain revisits and, like a tax audit, causes us to review all that may have contributed to it.  If pain is severe or chronic enough, we may also and again tumble down the rabbit hole of despair and worry, taking our activities, our social life, our optimism and our clear-headedness with us.  Once untreated pain becomes chronic, we may come to believe that we need yet more invasive procedures to treat it including nerve blocks, opioids and possibly an amputation, besides eternal use of over-the counter anti-inflammatories such as Tylenol.

Use of K-tape can detour, postpone or eliminate falling down the rabbit-hole of despair and distance us from reliance on more extreme pain management measures.  As a treatment modality, its use is supported by medical research, while also being accessible, easy to apply and almost immediate in offering relief. But, like tape itself, please always adhere to a suitable PT routine, stick to your medical team overall, and rest when needed so you can roll with the punches of life with more clarity.

RESOURCES

www.verywellhealth.com/kinesiology-tape-in-physical-therapy

physicaltherapyproductreviews.com/kinesio-tape

http://www.ncbi.nlm.nih.gov/pubmed/24819349

http://www.researchgate.net/publication/262268376

13. Micro-Movements

 

lake_bubbles

If you spend enough time out of doors observing nature’s ways, you learn to recognize that the occasional movement of a tree branch or bubbles breaking the surface on a body of water means something is moving about (sometimes far) below your site line.  Even though I cannot see them initially, I know that squirrels are near our balcony when I see the smaller branches of our tree shaking.  Worse, in this teeming urban city of Bangkok, I know that rats are in the garbage area when I see trash moving without apparent assistance.  Micro-movements of this particular sort serve to warn us, perhaps even to protect us.

In orthopedic terms, micro-movements operate along the same principal except that the hint of movement below your site line indicates joint instability, or proximal stress shielding**.  Its signals are lower leg pain, ankle, shin and calf muscle fatigue and joint buckling (giving out) or all at the same time.  Any sign of pain or buckling indicates that the metal joint is moving more than it should at or above or below  the knee joint itself: surrounding musculature is over compensating for the instability and contributing to the pain.

The effects of micro-movements are not to be underestimated.  They cause discomfort at best, searing pain and immobility at worst.  Orthopedic research has long clarified that micro-movements of a joint replacement, over time, causes not only joint damage but causes particulate buildup between the metal and the bone.  Eventually, this build up serves as a wedge to loosen the metal, forcing its owner to have a revised joint replacement.

But, what happens if the revised joint replacement begins to shake its branches just months after the surgery?  I can tell you in some detail since it is happening to me now, seven months after my knee revision surgery.  To be clear, the revision knee surgery was a mechanical success.  All alignments were precise, and the physical therapy routines were followed.  I just happen to thrive on physical discipline and on endorphin highs that come from good workouts –  and slowly but surely subjected my knee to more movement that it should have endured.  I have been experiencing severe shin splint pain, and an occasional sensation of the bone bending – this is an odd, painful and haunting sensation, like watching a contortionist bend backwards just too far to comfortably watch. Last week, as I stood cutting a lemon, my knee once again just buckled and the surrounding musculature went into cramping overdrive to compensate. These shin splint sensations and lower leg muscles giving out finally forced me to pull my crutches out of the closet (where they had been happily stored for over two months) and made my way back to my orthopedist for new x-rays.  Sure enough, the metal tip of the lower leg prosthetic had begun to lean into one side of the marrow of the tibia.  A clearly articulated balloon of space now surrounds the tip, caused by micro-movements said the doctor.  Like a hippo underwater, this bubble warns me that changes have to be made in my daily life in order to give this new, revised (and in my book, final) replacement a chance to recuperate.  Otherwise that hippo (second revised surgery) will attack.

Tibial stem bubble

(While this photo is of a first time total knee replacement, it effectively showcases bone loss/bubble aggravated by micro-movements.)

What needs to change? The amount of rest and the amount of movement in my daily life.

  • Practicing disciplined leg rest. I resurrected my bed-tray to carry books, liquids and snacks to wherever in the home I need to plant myself for hours at a time.
  • Prioritizing my weekly calendar so that I rest for enormous periods of time before going to this or that event.
  • Walking slowly and walking less. To and from the bedroom and kitchen is a hike.
  • Needing to lose weight is critical too – and easier said than done when movement is limited. But I have managed to minimize starches (grains) and sugars and to control my need for sticky rice.  The truth is, this is the hardest part of healing for me.  I am not enormously overweight but losing 15-20 pounds can only help.

Tray with ipadAdjusting my PT routine is also essential:

  • Reducing gym workouts to 3 times a week
  • Eliminating double leg bridges using a large physio-ball (65) since this exercise contributes to shin stress
  • Focusing on abductor and adductor exercises with the ball
  • Rolling the ball from one extreme side to the other, relying only on stomach muscles to give core muscles a decent workout
  • Starting and ending the gym workout with a plank hold for 70 seconds
  • Paddling non-stop in the pool for 25 minutes at a time.  There are many products to buy to help ones pool exercises.  But I like to recycle what I have, including all my lead-based weights bought for my first knee restructuring surgery over 35 years ago.  I wear a five pound weight like a shoulder bag. It forces the torso muscles to remain activated in order to keep the head above water.  The aerobic effects are tremendous and every aspect of the body gets attention without undue stress.  Five minutes spent with straight-legged lifts (70) while sitting on the pool ladder rounds out the heavy breathing portion of my pool time.  I strap one-pound weights to my thighs – avoiding ankle weights for the micro-movements they impose on the knee – and off I go.

swim gear

  • If I can stomach the hot and dubious water quality of Bangkok’s 50 meter pool, I stretch myself out there once a week.  It is a pleasure to crawl stroke uninterrupted by walls.
  • Using swim noodles to hold the body up while laying in the water and mediating. Meditation is front and center to my overall revised program since peace of mind is in higher demand now that my limitations are clear.  With ears underwater, I can only hear my breath and an occasional bird.  What could be more relaxing?

48-letting-go-of-past-mistakes, meditating in water

  • Adjusting my self-perception again. I am an active person, still young(ish) at heart and certainly not willing to stop being out in the world, though too many times, I stay inside repairing. What seemed extreme before now seems practical: a wheelchair.  The possibility of another surgery is unbearable.  So yes.  Now a wheelchair looks like a friendly, smart tool to rely on just as my crutches, canes and arms of friends and family members have been.

So reader, two steps forward, one large big step back.  In my case, a revised knee replacement has truly required a revised life.  Each post-operative phase reveals how to continue adjusting.  One thing, for me, that remains true through all of my surgeries:  The faster I strive to heal the more I need to slow down, this time for some time.  Thankfully, my reading list is long.

chair in library 2

 

**  Among the many research articles on the subject is this handy-dandy one:   journals.plos.org/plosone/article?id=10.1371/journal.pone.0177285

NOTE: All photos are stock internet photos aside from the photo showing weights.

12. How far have we come?

Seven months have passed since I had revision TKR surgery and movement is afoot (pun intended)!

  • Within the medical industry itself.  Study and use of stem cells as a means to treat health care issues now has a formal name, Regenerative Medicine (see Blog 11), and is one of the fastest growing biomedical industries in the world  (Technology and business trends in regenerative medicine, Cecilia Van CauwenbergheFrost & Sullivan, USA,  November 29, 2017).

Location of Stem Cell research

Stem cells are being used to manage cardio-pulmonary issues, macular degeneration and perhaps most prominently, joint and spinal problems, suggesting the possible elimination of metal joint implant devices in the next five years (Reenita Das, Forbes, Nov. 6, 2015).

While the author made a very optimistic declaration for the entire and utterly entrenched medical industry of orthopedics, it is very true that consumers can now find and secure stem cell therapies to avoid metal implants (see Blog 11).  The same article energetically describes how:

  • Over 2500 regenerative medical trials are in progress
  • Approximately five hundred regenerative medical products are currently on the market
  • Over 5 billion dollars have been invested (worldwide) in regenerative science research and development
  • Notably, sixty thousand registered and monitored stem cell procedures now occur annually.

This is all good news despite or because of the trauma, pain and life changing demands  on patients imposed by the difficult, real, relationship between bone and metal.  Gladly, by the time our children need joint repairs, using their own stem cells will be the protocol most advised and (do we dare hope?) insured.

  •  My progress slowly but surely moves forward.  After 7 months of daily physical therapy, required rest and pain management,  I have graduated to cane-less walking most days.  While I keep a colorful collection of canes by my door, I forget to select one of them, now daily, before stepping out.  This is a tectonic change for me and one that I celebrated last night when, walking into a busy night flea market, I realized that I did not have my cane.  I had completely forgotten about it and traveled by foot, skytrain, taxi and foot again before noting its absence – which stopped me in my tracks.  I took another moment to self-congratulate and then made a beeline for a banana chocolate crepe followed by a Singha beer to celebrate.  Today, I rest.

Crepes

 

Singha

 

A few practices remain the same:

I really cannot endure a walk of more than about 500 meters (about one third of a mile) before my lower leg seizes up.  I must rest and for the remainder of the day, that night, the following day and night.  This well tested formula (500+ meters = two nights and up to two days of rest) seems pretty consistent and therefore predictable.  Consequently, my apartment has become my haven, palace,  office and detention center.

I continue to walk with a limp but if I remember to activate my core muscles, stand erect and lift the leg muscles as I walk  (a ‘walking meditation”) my stride tends to straightens out.

A few other strategies have helped along the way:  I stopped using sugar in my coffee  – a goal I never wanted to attempt but weight gain forced me to try.  My spirits are up!  I am better networked here in Bangkok, our new home.  I now regularly participate in interest groups, attend museums, and explore sections of the city I could not touch not too long ago.  Tomorrow, my son and I will visit yet another landscaped park to compare its layout to others in the city.  Our plausible goal is to see all of the parks within the Bangkok city limits by mid-April .  We look forward to meeting that goal.

Ensuring that physical therapy is a part of my everyday routine is critical.  When I think of the work I had to do for three months to attain a semblance of mobility immediately after surgery,  and then requiring an additional four more months of careful rigor to rid myself of a cane,  I shake my head in amazement at all that needs to be done to regain indispensable strength and basic mobility.  Physical therapy is here to stay in my life and in its various tailored forms.

photo pool and wieghts

In the pool, I spend about 45 minutes in constant motion including laps, and swimming the perimeter of pool with a five pound weight in my suit to demand more from me aerobically and muscularly.  Doing at least ten rounds around the pool using all sorts of strokes otherwise unacceptable to this Master’s level swimmer includes the daring dog paddle, modified breast stroke, bicycle and jogging movements, back strokes and any other movement that strikes me but does not strain my knees – all which offer a work out I need and enjoy.  In the quiet hours of the early morning the pool is cool, calm and unencumbered with humans.  Birds are discussing their issues, the sun is grazing the leaves and bouncing off the water and I am at peace despite also breathing heavily.   I end with a series of in-the-water yoga stretches and pulling the legs and arms in opposite directions to give my spine a massage followed by a period of lifeless floating, at one with the world.  It is the time of day that I most enjoy and look forward to.  Because this activity is inherently beneficial as well as enjoyable, I never think about whether or not to invest in it.  I just go – after my cup of coffee and before the rest of the world wakes up.

In contrast, I have an unenthusiastic relationship with our gym and its exercise balls every other day I am not in the pool.  My gym regime includes plank poses, large ball manipulations with twists, hip lifts and holds and plenty of stretching in between.  If it were not for the pool to jump into at the end of my gym time, my PT regime would be a bitter pill to swallow since the workout itself is, quite honestly, hard.

PT and large ball

At my age (62) and after birthing two children, I have not managed to lose weight nor the masses of noticeable material clinging to where fashionable clothing will not tolerate.  Clearly getting rid of at least ten pounds would help my joints and will be my next goal now that I can walk – more than less.  Less crepes and beer and more of everything else I can do physically is the plan.  What is yours?  Keep our blogs readers posted!

11. Adult Stem Cell Therapy v.s. Total Knee Replacement. No comparison.

 

Me and Geoff
Geoff and Amanda fishing in northern Minnesota, around 1960.

My brother Geoff and I are now in our early 60’s and have had the same knee problems born from years of active use.  We both have had to manage bouts of knee repair starting with torn meniscus, floating cartilage and eventually, degrees of osteoarthritis.  Geoff, however, avoided a total knee replacement (TKR) by investing himself in ‘Advanced Orthobiologics’ or ‘Regenerative Medicine’ by using his own adult stem cells to repair.  I, on the other hand and starting long before adult stem cell therapies were accessible, took the now well worn path leading to a total knee replacement, as the rest of my blog site details.

What are the differences between approaches?  Many

Which approach is better?  There is no doubt that there is no comparison. Use of adult stem cells to manage joint damage is the preferred route to take, if your joint passes an applicability exam offered by orthopedic surgeons certified in Advanced Orthobiologics or Regenerative Medicine.

I am now into my sixth month recuperating from a revision TKR and recently progressed to walking about 100 meters without needing a cane.  My brother, on the other hand, one week after his second stem cell therapy in 6 years, returned to wind surfing, cross country skiing, and biking, among other activities.  He plans to participate again in the American Birkebeiner cross country ski race this winter and will once again return to the Columbia River Gorge in Colorado to leap and skim waves with his windsurfer, knees bent, taking all the shocks and torques my body cringes to think about.  The benefits of regenerative medicine are very real starting and ending with less or no pain, a more active quality of life, more natural resources to draw from for a longer period of your adult life, no invasive surgical procedures and thus total avoidance of any risks associated with TKR surgery.

IMG_0175
Geoff at the American Birkebeiner, 2016

So, what is it like to actually experience adult stem cell therapy? Let my brother, the real author of this article, tell you his story.

  1. What was happening to your knee at the time that you first sought orthopedic attention?

I first tore my right lateral meniscus in the early 80’s playing tennis on a freshly refinished court that had a surface like 60 grit sand paper.  The pain and swelling was pretty immediate.  I recall limping around for a few days, maybe weeks before seeing a sports medicine doctor. Their recommendation was to avoid surgery until the injury interfered with my quality of life.  For the next 6 months or so I tried running and playing tennis only to realize my mileage and agility were diminishing and the pain was increasing.

  1. What kind and how many doctors did you visit?

Over the course of the next 20 years I had 2 more arthroscopic surgeries for torn meniscus, one each for both knees.  I recall seeking the opinion of a couple of orthopedic surgeons before settling on a surgeon who was the team doctor for many professional sports teams in Minnesota and traveled with the U.S. Winter Olympics team to Japan.  Both surgeries were done by this same surgeon.

  1. How did you feel about your (mobility and life-style) future with each diagnosis/prognosis that was made?

After the first surgery my knee did not feel quite aligned for about a year…I think persistent running and tennis help pound or grind it into submission…Today, I would choose a softer approach to aligning one’s body.  The recovery from the second surgery was much quicker due in part to a better surgeon and improved techniques. My mobility was pretty good for roughly 10 years.  When I reached age 45 my legs started springing apart.  I was always in some sort of recovery from pulled leg muscles.  According to my current Osteopath, I did not have enough body work done for the level of activity I was doing.  My body structure was out of alignment and my soft tissues were like dried out leather. To top it off, I tore a meniscus again and had a joint mouse (cartilage chip) floating around that would stop me in my tracks if it lodged in the joint or under my knee cap.  I eventually had to have a third surgery to remove cartilage chip and clean up the meniscus tear.

  1. What or who led you to look into stem cell therapy?

Ms. Deanne Aronson, Osteopath and certified Acupuncturist.  She is also my fiancé of 18 years.

IMG_0179
Geoff and Deanne recently biking in the Twin Cities, Minnesota
  1. What features to stem cell therapy appealed to you?

It’s regenerative rather than invasive and extractive.  It uses your own cells to assist your body in healing itself…no machinery. Minimal pain throughout the procedure and recovery.  It is a small scale personal outpatient treatment alternative to those more impersonal complex procedures and protocols offered through the medical industrial complex.  It makes the complex simple.

041617_stemcells_THUMB_LARGE
Adult Stem Cells
  1. Tell us about your first stem cell treatment.

Six years ago torn meniscus, a torn ACL and budding osteoarthritis compelled me to find a certified stem cell orthopedic practice. I found that practice in Colorado at the Regenexx clinic, the first to use adult stem cells for orthopedic injuries (www.regenexx.com/our-approach).  I flew to Colorado, rented a hotel room and began the week long process.  In those days, it took about 5 days for the complete treatment, including initial prolotherapy, blood draws, processing, and then stem cell and PRP injections. I was on a strict recovery program for 6 weeks which included immobilizing my knee with a brace and slowly increasing activity.  The Doctor (Schultz) was only able to harvest enough stem cells at the time to treat my torn ACL and meniscus.  There were not enough stem cells to treat the budding arthritis on the medial side of my knee. This is the only spot that had presented any concern since the procedure was completed. My knee for the most part was doing fine up to about 2 months ago when it clearly had degenerated to the point of prompting the second treatment. Besides windsurfing, I had roller skied and biked far too much and these activities set the arthritis on fire.

  1. How has the procedure changed since your first treatment?

The procedure has changed significantly over the last 6 years. Apparently they have refined the bone marrow extraction methods from the hip bones and have been able to harvest several times the amount of stem cells than were possible in the past.

  1. What features of stem cell therapy are difficult?

Not much…if you like needles.  There is a lot of poking around involved with blood draws, prolotherapy, bone marrow extractions,  prp and stem cell injections.  However, I remember being a bit anxious with my first treatment in anticipation of the bone marrow extraction.  In fact, Dr. Schultz paused the procedure and asked why my pulse was so high.  I told him his literature talks about bone marrow extractions with no indication of the pain level one may experience. I had conjured up in my head that it would be on a par with bone cancer treatments or spinal taps. I was happy to find out the pain level is not much more than a typical shot.   Their literature has since been revised.

Also, I received 3 rounds or approximately 10 injections each for prolotherapy treatments in Minneapolis prior to going to Boulder for the stem cell treatments.  This was torture…and unnecessary.   The local doctor that performed the treatment was pretty unsophisticated and did not use imagery devices to guide the horse needles into my knee…he was flying blind.

A good doctor will utilize fluoroscopy and/or ultrasound imagery in real time to guide injections into the joint capsule.  If done well, the pain level isn’t much more than acupuncture.  Doctors may offer a sedative to relieve anxious patients.  However, I found just breathing deep and going to my happy place works just fine.

Stem-cell-therapy-for-knees

  1. What are the features of a knee replacement that are difficult for you to accept?  

I would consider knee replacement for those people whose joints are damaged beyond the point where stem cell treatments are a reasonable solution.   I have also experienced firsthand the profit motives of the orthopedic industrial complex and doctors who reject the idea of stem cell treatments and prematurely recommend knee replacement.  As you know, a book could be written about the hideous lobbying by our western medical system and their efforts to obstruct FDA approval of stem cell treatments and detour any advancement of alternative medical treatments that would cut into profits.

100_1283 Knee Jonit REPLACEMENT IN PROGRESS.
Standard knee replacement procedure
  1. Under what conditions would you urge people to have a knee replacement?

When they have exhausted all other alternatives.

  1. What advice would you give people with acute knee pain?

If you go to a standard orthopedic surgeon they will figure out a way to use a knife to fix your pain. Instead, begin with the basics and consult professionals that specialize in noninvasive biomechanical and structural body work such as osteopaths, acupuncturists, chiropractors, or rolfers, etc.  These treatments should be the first line of defense… structure governs function.

  1. How would you advise people who want stem cell therapy but cannot afford it?

Good question.  Since adult stem cell treatments are not yet approved by the FDA, the costs are typically out of pocket.  I was fortunate enough to have an Health Savings Account (HSA) and used pretax dollars to pay for my procedures.  I also tried to bundle medical and dental expenses in a year in order to reach the threshold for income tax deductions.

I would also consult with providers to see if they would accept installment payments for treatments.

  1. Are there any elements of stem cell therapy that need improvement? (method of care, location, cost, unsure outcomes, chronic pain, lack of easy access…etc) ?

Yes. Approval by the FDA so the treatments can be paid for through insurance.

  1. Six years ago, stem cell therapy was not that common.  It seems to me that it took some courage to have agreed to this kind of therapy.  What gave you the courage to fly away from your home, rent a hotel room and subject yourself to this newish form of treatment?

Deanne Aronson.  If it was not for my forward thinking insightful partner I would not have known about stem cell treatments.  I also knew that if I had another arthroscopic surgery most of my remaining meniscus would be removed and I would be heading toward full knee replacement within a few years.  Full knee replacement would also limit certain activities that I was not willing to eliminate from my life quite yet.  I also realized that I was at an age when I would probably outlive the initial artificial knee and have to have that replaced in the future as well.

The more we researched stem cell therapy the more I was intrigued with the possibilities of regenerative medicine and was willing to give it a try.

  1. What personal traits are required of a person to have stem cell therapy?

A heartbeat.  Six years ago at 58 years of age, I was considered a marginal candidate.  The thought was that the older you are the fewer stem cells you produce.  It is my understanding that this notion has been disproved.  In fact, Deanne Aronson referred an 86 year old patient to a certified Stem Cell therapist, (Dr. Hanson) and is now receiving stem cell treatments.  Apparently, good nutrition plays a larger role in the quantity and health of your stem cells than age. 

  1. What personal traits are required of a person to heal from stem cell therapy and protect their knees from further damage?

Patience, a positive attitude and an understanding of the body’s ability to heal with proper nutrition, exercise, and biomechanics.

  1. What physical activities are you doing now?

Windsurfing, cycling, roller skiing, downhill skiing and freestyle skate skiing.  Over the course of the last 6 years I have done over ten, 50 plus kilometer skate ski events and competitions including the American Birkebeiner and the Minneapolis Loppet.

Snapshot 1 (11-10-2011 9-45 PM) copy
Geoff windsurfing in the Columbia River Gorge, Colorado
  1. How long will your second stem cell injection last?

We will have to wait and see.  The first treatment (6 years ago) never degenerated.

  1. Do you anticipate further degradation of your knee?

Well, through the process of the second treatment we discovered I have a budding bone spur located below the medial side of my knee cap. This apparently cannot be cured by stem cells. I am hoping to keep the spur at bay through biomechanical therapies.

  1. Do you anticipate possibly needing a metal knee replacement sometime in your future?

I hope that regenerative medicine will continue to advance to the point that I can avoid metal knee replacements.

  1. If so, will you allow it to happen?

I may have no other choice if I have exhausted all other possibilities.  Hopefully the metal knee replacement industry will also make some advancements to minimize risk and improve outcomes.

  1. If you have to have a TKR, what options will you foresee having? 

Learning how to embrace a more sedentary lifestyle.

END of interview.

Am I jealous of my brother? No, though envy slides in occasionally.  I am happy for his sustained level of activity. Even if he chose to live a more sedentary lifestyle I would be happy for his absence of chronic pain.  But, more so, I am haunted.  Something is wrong, terribly wrong, in the medical field of Orthopedics when reliance on highly invasive partial and total metal implants are on the rise, with all of their associated risks (Blog 7), while the far less invasive regenerative medical therapies remains side-lined, stubbornly out of reach by insurance companies and held at a long arm’s reach by the US Food and Drug Administration (FDA) for reasons that remain persistently suspect.  While a future blog will elaborate on this declaration, I encourage you to add these below information sites to your research list. When it comes to managing our health, researching our options can be only a click away for a less complicated, less painful, lifetime.

http://www.regenexx.com/resources/free-e-books/

http://www.stemcellsgroup.com

Castel Gandolfo, Italy
A stroll through Castel Gandolfo, Italy 2018 with my sister and son