Michelle Stiles's Blog, page 6
February 9, 2015
Are You Too Old To Have A Knee Replacement?
If you have been asking the question, “Am I too old to have a knee replacement?”, listen up, this study may help you decide.
While the term “frail” is not a term that most people would use to describe themselves, a new study has created a frailty score from 11 data points that may be useful to determine vulnerability to complications and mortality, answering the question just how high is my risk going into knee replacement surgery.
This study used a large population of 40,469 patients (61 percent of which were knee replacement patients, 39 percent hip replacement patients) and retrospectively calculated a simplified frailty index consisting of such variables as history of a heart attack, stent and hypertension.
The researchers then ran calculations to determine whether the frailty index had any relationship to poorer outcomes and in fact they found the following significant results.
Frailty Score And Relationship to Mortality:
Frailty score of 0/10–.08 percent
Frailty score of 4/10– 2 percent
Frailty Score And Relationship to Complications:
Frailty score 0/10–.67 percent
Frailty score of 4/10– 6.24 percent
Highest possible frailty score was 11/11. The population sample was relatively young with a mean age of 66 which is most likely reason why they only had a maximum frailty score of 4/10.
While more research is needed, it is not a bad place to start a discussion with your surgeon if you are worried about the risks of having knee replacement surgery.
Dr Adams, one of the lead researchers “points out that this frailty score could also be used to show that elderly patients should not be denied an option for surgical treatment. Patients who have low frailty scores will probably do well and should be considered on the merits of their health, and not solely on age.”
The moral of the story is that “age” probably has less to do with good knee replacement outcomes than” significant” medical histories. Ask your surgeon about the Frailty index mapped to the ACS NSQIP database.
If you decide to proceed with the surgery, Find the Best Hospitals for Knee Replacement Surgery in Less Than 1 Minute
If you are worried more about knee replacement recovery than knee replacement surgery, Find Out More About Knee Replacement Recovery Times
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Free Kindle Book Giveaway-Knee Replacement Wisdom
Free Kindle Book Giveaway November 15-17
Looking for a good read over the thanksgiving day holiday?. If so pick up Fast Track Your Recovery From A Total Knee Replacement: How to Eliminate Pain and Pain Medicine The Quickest Way Possible, by yours truly.
Ok so I’m a little biased. It is a great way to get educated prior to your surgery. After you fill your tummy with left over turkey and stuffing, grab a glass of wine, head over to the sofa and read away!
While it’s not rocket science, included are those silver pearls of knee replacement wisdom that come from years of exclusive experience with knee replacement surgery recovery that you just can’t find on Ask.com.
I am very proud of the fact that each and every patient who learns this system and applies it make steady industry-beating progress. There are people that fail to follow through but very few. Most people are delighted to be in the bus driver’s seat instead of bouncing around in the back near the lavatory uncertain of how the story would end.
Knee replacement recovery is simple and largely predictable when you know what I know. You can get that knowledge tomorrow for free.
And by all means, remember to tell a “gimpy” friend or two about the sale. They will thank you later…I promise.
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10 Reasons Not To Trust Stryker for Your Knee Impant
You may or may not have heard about the FDA bringing the hammer down on Otismed, a subsidiary of Stryker the big knee replacement implant industry giant. In a nut shell, the CEO plead guilty to selling the The Otisknee, a cutting guide that helps surgeons align a “Custom knee” after the FDA denied the device 510K approval. See my guest post on NaturalNews.com, a site I highly recommend by the way, for the full story.
Below I have included a detailed chronology of the events from both Otismed and Stryker’s perspective. The story is not pretty, at least not for the knee replacement consumer. Now more than ever you need to be an educated buyer and stop listening to the marketing messages while blinding trusting healthcare professionals.
Timeline Facts
1) Between May 2006 and September 2009, OtisMed sold more than 18,000 OtisKnee devices, generating revenue of approximately $27.1 million.
2) On Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee.
3) On Sept. 2, 2009, the FDA sent OtisMed a notice that its submission had been denied, noting that the company had failed to demonstrate that the OtisKnee was as safe and effective as other legally marketed devices.
4) Chi, The CEO of OtisMed directed employees to organize a mass shipment of all OtisKnee devices that had been manufactured but had not yet been shipped and suggested ways for the employees to hide the shipments from FDA regulators.
5) At Chi’s direction, OtisMed shipped approximately 218 OtisKnee guides from California to surgeons throughout the United States, including 16 to surgeons in New Jersey.
6) Chi faces a statutory maximum sentence of one year in prison and a $100,000 fine, or twice the gain or loss from the offense, for each of the three counts of introducing adulterated medical devices in interstate commerce.
7) Chi awaits sentencing by Judge Cecchi, on March 18, 2015.
Here’s the backstory that is actually far more disturbing and that will not be played on the media.
Stryker Timeline and Entanglements
1) Specifically, the settlement alleged that in May 2006, OtisMed, through co-promotion activities with Stryker Corporation, began commercially distributing the OtisKnee without having received clearance or approval from the FDA for the device. [Stryker a large Medical device company would have known FDA clearance had not been obtained]
2) On January 12, 2008 The Journal of Arthroplasty published a study on the OtisMed Custom Fit Knee. The results suggested that patients having an OtisMed Custom Fit Knee might experience early implant loosening or wear and eventual failure due to gross limb mal-alignment. Some surgeons reported aborting the surgery and using traditional techniques due to concerns during surgery.
3) On Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee.
4) On Sept. 2, 2009, the FDA sent OtisMed a notice that its submission had been denied, noting that the company had failed to demonstrate that the OtisKnee was as safe and effective as other legally marketed devices. [Why did it take the FDA, one year to investigate this and come to a conclusion?]
5) Stryker announced the acquisition of OtisMed, in November 2009 despite obviously knowing that the device had issues and was being marketed without FDA Approval.
6) In 2010 Stryker was served with subpoena by the DOJ relating to sales and marketing of the OtisKnee, a device that has not been approved by the FDA
7) May 2011 Stryker’s announced FDA approval for the ShapeMatch Cutting Guide through 510(k) clearance [Note Stryker is able to get approval for cutting guides even though two years previously the FDA refused to approve the Otisknee stating that safety and effectiveness had not been demonstrated]
8) On May 31, 2012 Stryker offers 33 million to the DOJ to settle allegations of violations of federal laws related to sales of The OtisKnee not cleared by the U.S. FDA.
9) In January, 2013, 18 months after being approved, Stryker’s ShapeMatch Cutting Guide was formally recalled by the FDA with a Class I recall. Read more
10) On May 31, 2012 Stryker offered 33 million to the DOJ to settle allegations of violations of federal laws related to sales of a device (The OtisKnee) not cleared by the U.S. FDA.
Final Word On Knee Implants
The Consumer Union’s Safe Patient Project states …
Instead of pre-market safety testing, the FDA primarily relies on “post-market” reporting to Medwatch, a system for physicians and patients to report problems with implants. When enough problems or “signals” are reported, FDA may send out notice to the companies and the companies can choose to voluntarily recall their products. This means virtually every hip and knee implant patient is an unwitting participant in a giant, “post market” test to see which products are actually safe and which ones turn out to harmful or ineffective.
This is true only in the case of newly marketed versions of implants. There are implants with significant histories and track records already on the books. Select the “Honda Civic” of the knee implant models and you will be fine. Do not listen to marketing hype or you will be the test case.
Sources
Consumer Union Report
http://safepatientproject.org/press_release/consumers-union-calls-on-medical-device-makers-to-provide-warranties-for-hip-knee-implants
Dr. Stefan Kreuzer MD
http://www.stefankreuzermd.com/custom-fit-knee-replacement.html
Department of Justice
http://www.justice.gov/usao/nj/Press/files/Otismed%20News%20Release.html
FDA Source
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426134.htm
Gibson and Dunn
http://www.gibsondunn.com/publications/pages/2012YearEndHealthCareEnforcementUpdate.aspx
Depuy FDA Action
http://www.aboutlawsuits.com/depuy-warning-hip-implant-knee-replacement-product-12387/#sthash.E3LVlwOz.dpuf
Press Release
http://orthodoc.aaos.org/SportsMedicine/BP%20Otis%20Knee%20Press%20Release.pdf
Reuters
http://www.reuters.com/article/2014/12/08/us-health-stryker-idUSKBN0JM24K20141208
Bloomberg
http://www.bloomberg.com/news/2014-12-08/stryker-s-otismed-will-plead-guilty-in-knee-device-case.html
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10 Reasons To Start Your Recovery After Knee Replacement Surgery At Home
Recently Daily RX reported on a study conducted in Australia and reported on in Arthritis Care and Research. The researchers found that patients had the same ability 6 weeks after surgery to bend or straighten their knee, similar levels of pain, readmission rates and the ability to walk 50 feet whether they followed a monitored exercise program at home or participated in a regular outpatient rehabilitation program.
The main implication of the study is the potential to lower healthcare costs across the board if patients are able to recover at least as well at home as at an outpatient clinic. While I will admit this is an important goal especially as the number of surgeries mushroom with the aging baby-boomers, there are many other excellent reasons to do your primary total knee replacement rehab at home. Click you heels together and say with me- “There is no place like home. There is no place like home.”
Benefits of Home Therapy Versus Facility Care
1. Less Chance of Infection-Better to deal with the bugs you are familiar with than the bugs you are not familiar with. Foot traffic in a rehab facility is high. Visitors come in and out. Staff that you will make contact with include aides, nurses, physical therapists, occupational therapists dietary, laundry, and administrative can all unwittingly be carriers for potential germs that can easily get the best of you especially right after surgery when your bodies defenses are down. Knee replacement surgery risks include being more vulnerable to general infections than the normal population. Landing a cold or flu virus 1-2 weeks after your surgery can really throw a wrench into a quick recovery.
2. You’ll Be More Active At Home- Patients who go home do more stuff for themselves. Caregivers at home are rarely able to be of service around the clock. That means you’ll get up and walk more, get some of your own lunches or snacks and get your own ice bag. Of course for the first couple days it ok to get some extra attention and help but after that…that best thing is to start doing for yourself as much as possible so that you can shorten recovery time for knee replacement.
3. You’ll Be Free to Establish Your Own Routine- For dynamic and energetic people there is no worse torture then to be put on someone else schedule, at the whim of busy nurses and staff constantly waiting for responses. When you go to your own home you can blessedly set your own schedule. Want to eat a late breakfast; snack after lunch; or do an extra set of exercises? You are king or queen.
4. Do More Rehabilitation For Your Knee and Less for Your Arms-For the majority of people who have nothing wrong with their upper extremities, wasting time on arm exercises (with OT) is stealing rehab time that could have been better spent on the primary problem- your knee.
5. Eat The Food You Are Used To- Nothing can be worse than eating food you don’t like or your body is not used to when you are in recovery mode. Of course if you usually cook and your spouse can’t cook worth a hill of beans you can still make up meals ahead of time to freeze so that no fuss home cooked meals are ready at your disposal when you get back from the hospital.
Benefits of Home Therapy Versus Outpatient Rehabilitation Care
1. Less Chance of Infection- The same rationale holds here as above. The more foot traffic the more potential for infection no matter how hard the facility tries to keep things clean and bug-free.
2. Decreased Cost- For many the co-pays don’t kick in till you start going to outpatient and using Medicare B and even many insurances provide for a certain amount of home care visits per year without additional co-pays. The costs can really add up as you pay out more and more for your recovery after knee replacement surgery.
3. No Need For Someone To Drive You- There is no doubt that your knee replacement rehab will progress faster using narcotic pain pills at least for the first two weeks. This means you need a driver to get the outpatient facility safely and legally. This can be hugely problematic for spouses who are still working age.
4. Do More Rehabilitation For Your Knee- While most outpatient facilities will thankfully focus on your knee and not your arms, the reality is that once you get done with your “monster session”, you are very unlikely to do any other exercises before or after. Frequency is one of the most important principles that lead to early and speedy range of motion recovery. People utilizing this mode of recovery tend to delegate responsibility to the “experts” and they feel less qualified and competent to own their own rehab progress and success.
5. Less Tempted To Overdo Walking- Going out and about especially in the first two weeks, most patients find it tempting to stop for lunch on the way home or to grab a few things at the grocery store. These are really bad ideas and most will learn the hard way after they suffer increase pain after knee replacement surgery, a setback no one wants to deal with.
Home really is the best place to begin your recovery; get back to comfortable surroundings, establish your own routine and focus in on your task with a defined program away from unnecessary distractions and unwanted delays.
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