Introduction To the Term

First of all lets look at what is actually meant by the term “custom” knee replacement. Are you getting a custom implant? The answer is “no”. You are getting a customized cutting guide that supposedly will ensure perfect placement for your knee implant. And while this intuitively seems like a very good thing, let’s examine this topic further.

History

Here is a brief history of somewhat recent innovations to the traditional model of conventional “off the shelf” implants

1) Gender Specific Implants- smaller and more tapered “off the shelf” versions

2) Computer Navigation- this aids in alignment but has nothing to do with the size and shape of the implant itself.

3) Custom Knee Replacement: Cutting guides are created by imaging the patients knee (CT or MRI) and then forming a cutting guide specifically for that patient. Some guides specify where the surgeon should cut the bone while other types guide the insertion of pins so that standard cutting guides can be used more accurately or so the theory goes.

So who are the major players in the market?

Biomet (Signature System/Vanguard)

ConforMIS (IFit/ITotal)

DePuy (TruMatch/Sigma)

OtisMed (OtisKnee/Triathlon) a division of Stryker

Smith & Nephew (Visionaire/Journey)

Wright Medical (Prophecy/Advance)

Advantages

The purported advantages over conventional surgical guides are as follows:

  • Improved alignment
  • Decreased operative time
  • Increased patient throughput
  • Decreased instrumentation
  • Reduced risk of fat embolism and intra-operative bleeding due to minimal bone removal (i.e., no intra-medullary canal reaming)
  • Decreased tissue loss
  • Shorter recovery
  • Reduced postoperative pain
  • Decreased incidence of infection
  • Lowered costs

Sounds great doesn’t it? Sign me up! It all seems to make perfect sense. Why would I not want a custom fit? What could go wrong?

But……..wait

Product Recalls

On January 23, 2012, Biomet sent a recall notice to its customers explaining two lots of Signature guides were incorrectly labeled. Biomet instructed its customers to return any affected product and notify hospital personnel if the affected guides had been further distributed.

Incorrectly labeled… yikes…you mean my personalized guide was someone else’s personalized guide?

Also if anyone remembers the Stryker lawsuit regarding their ShapeMatch cutting guide that I discussed in a previous blog post, it should be enough to give you pause.

Additionally, here is the list of problems with customized knee replacement cutting guides that were reported to the MAUDE database (A collection of reports from voluntary user facilities).

  • Incorrect/difficult template fit (48)
  • Template caused over-rotation (39)
  • Template caused incorrect cut (20)
  • Broken template during surgery (10)
  • Broken tool (8)
  • Sterilization-induced template malfunction (2)
  • Bone fracture (1)
  • Missing instrumentation (1)

Little Conclusive Evidence That They Are Better At This Point

The ECRI institute released an Emerging Technology Evidence Report April 2012 for Total Knee Replacement Using Patient Specific Templates.They concluded that the evidence is insufficient to demonstrate the claims made for use of the guides.

Outcome reports_conventional

 

 

 

 

 

Outcome reports_Computerized

 

 

 

 

 

 

 

 

 

Screenshot images taken from ECRI report  The first table shows data comparing custom knee replacements to computer navigation and the second table shows custom knee replacements vs conventional instrumentation. The yellow panel area is for inconclusive results.

So who is behind the ECRI? Their mission is as follows… to research the best approaches for safety, quality, and cost-effectiveness in healthcare, ultimately enabling your organization to improve patient care.

But one must always follow the money when evaluating the so-called neutrality of non-profits.

Their website states that they have three funding sources.

Although ECRI Institute occasionally receives charitable grants to support our work, the majority of our funding is derived from three sources:1) Memberships from organizations—This membership model allows ECRI Institute to conduct research and provide information and advice, which is shared across our various memberships.2) Clients who engage us in custom planning and consulting projects such as quality system assessments, accident investigations, or strategic technology planning.3) Contracts, most often from government agencies—Examples include the U.S. Agency for Healthcare Research and Quality for the National Guidelines Clearinghouse and The Pennsylvania Patient Safety Authority, for whom we develop and maintain the Patient Safety Reporting System.

Private contracts, government contracts and memberships from clients. Geez sounds like a for profit business to me. Although I am not ruling out this data source, I would look further because a high volume of government contracts or big industry contracts just doesn’t seem unencumbered to me.

You can find their entire report Here

Additionally the most recent study on patient cutting guides was completed by the Journal of Bone and Joint Surgery  The authors concluded that…

“There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with standard instruments. The group treated with patient-specific cutting blocks had a significantly higher prevalence of mal-alignment in terms of tibial component slope than the knees treated with standard instruments.”

Dr. Tarlow,  who we have mentioned (Arizona Total Joint Surgeon who maintains his own blog), concurs with this report.

“Routine use can not be supported in uncomplicated knee replacement. Patients should not be influenced by marketing efforts suggesting widespread adoption of these products. “

In Summary:
Can things go wrong with conventional surgery..of course. I’m I trying to say that a customized template is a bad thing…not at all.

My purpose is to offset the deceptive quality of current marketing that lures people into uncritically adoption and acceptance.

Is a custom knee replacement the next best thing since sliced bread? The jury is still out.


Michelle, PT
Michelle, PT

Michelle Stiles called “the no nonsense” therapist, by her patients, created a company called Cowboy Up Recovery after recognizing the bankruptcy of the present medical model. Too many people regard conventional medical wisdom as gospel, ignoring the subversive influences of Big Pharma and Big Medicine.

She believes, Americans in general are being trained from an early age to defer to experts in numerous areas of life and losing the impulses for self-responsibility and self-reliance in the process. Over-diagnosis and over-medicating has become endemic.

While thankful for the best miracles of modern medicine, she encourages people of all persuasions to listen to their bodies and seek out answers to maintain not just an absence of disease but optimal health.

Her advice is: Cowboy Up, no one cares more about your health than you do.

    1 Response to "Custom Knee Replacement: Next Best Thing Since Sliced Bread?"

    • Michelle, PT

      I know this is late but will reply anyway for others who might read, The answer to Benjamin’s question is somewhat complex. First off many people will not be able to match the range in non-operative knee. There are a lot of reasons for this, type of knee implant, the surgeons technique (some surgeons are known for producing “tight” knees), therapy technique, and diligence. Swelling and tightness can be a nuisance for 6 months or more. Benjamin is worried that a traditional knee may have slightly limited his ultimate ROM however the important thing to remember is a traditional knee has been highly tested having been implanted in thousands of people and with high survival rates (number years of worry free service). This is a much more important result than a few extra degrees ROM in an untested or brand new model. I understand the desire to have the new knee be just like the old one but so far that is not the case. I would go with the tested knee every time. Don’t be the guinea pig!

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