Joint Replacement Patient Forum
Re: Nickel allergy - there is only a small percentage of people with nickel allergy.
First, don't worry too much about this now. Good standards have not established to identify possible allergies to metals in orthopaedic implants. Rather complete your course of healing for a typical knee replacement, and if you were having significant issues after about a year (post-op) then it would be reasonable to consider issues with allergies.
If you have an allergy and need a joint replacement, don't panic - there are devices suitable for nickel sensitive patients. The metal parts are coated with ceramic.
BIOLOX® delta ceramic implants
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Smith and Nephew Oxidized Zirconium knee replacement
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From Smith and Nephew website
"If it is determined that an implant made with VERILAST◊ technology is right for you, the femoral - or thighbone portion - of your implant will be made from OXINIUM Oxidized Zirconium - a patented and award winning ceramicised metal alloy that Smith & Nephew spent more than a decade developing.
During manufacture, OXINIUM implants undergo a process that transforms the implant's surface into a hard, ceramicised metal - while still retaining all of the durability of the underlying metal. In addition to being more durable than a true ceramic, this metal implant's ceramicised surface is more than twice as hard and therefore twice as resistant to the kind of scratching that can cause a cobalt chrome implant to wear out before its time."
If you are having problems with an already implanted device which you think may be related to allergy, steps are:
1. find out what kind of prosthesis you have and its make up
2. either you or your surgeon need to contact the Metal Allergy Testing Laboratory. which is in Chicago
3. a blood sample has to be mailed to them overnight mail
(Thanks to Maryo for this info)
LINK Lima News
Total knee arthroplasty may fail due to multifactorial causes which, however, all relate to either biological or mechanical conditions. Biological causes include allergic reactions to metal, as documented in studies. Around 10-15% of the general population is allergic or hypersensitive to metal. However, the phenomenon is not always predictable in case of joint replacements and the link between cause and effect in implant loosening cannot always be demonstrated with any degree of certainty.
All metals in contact with biological systems corrode and consequently release ions. In predisposed individuals, these ions may activate the immune system by forming metal-proteins and eventually generate delayed hypersensitivity. Nickel, cobalt and chromium are the most common allergens found in metal knee replacement devices. Titanium and vanadium as well as certain constituents of bone cement have been reported to elicit hypersensitivity responses.
Numerous clinical trials have looked into possible correlations between allergy and implant failure, however, none have so far proven a definite link between the two events.
One of the main challenges lies in the lack of universally accepted methods of investigation. Certain in vitro tests, based on the reactivity of the cells of the immune system to metal-proteins, have been proposed as diagnostic methods for evidencing metal allergy.
These are expensive procedures that can only be performed by highly qualified centres that can analyse only certain materials. As an alternative, epidermal testing (patch tests) are cheaper and can be used to assess a larger number of elements simultaneously. Patch tests are the most commonly used method for diagnosing metal allergy.
Recently, a trial was conducted by the Rizzoli Orthopedic Institute in Bologna (Italy), to assess the frequency of skin sensitivity in patients with knee implants, and to measure any impact this might have on the survival of the implant; the patch tests used the elements present in cobalt‐chromiummolybdenum (CoCrMo) and titanium-aluminium-vanadium (TiAlV) alloys, and in bone cement.
The study included three patient populations:
- one group of candidates awaiting a total knee replacement, studied prior to the procedure,
- another group of patients with stable knee implants and
- a third group of patients with clear evidence of loosening of the prosthesis.
The frequency of metal sensitivity in the patients awaiting surgery was similar to that of the general population and the most common sensitizers were nickel, followed by cobalt, chromium and manganese. The tests were significantly more positive in the patients with knee implants, both stable and mobilized.
More specifically, there was a higher frequency of positive reactions to vanadium in the stable implants with at least one component (the tibial plateau) in titaniumaluminium-vanadium alloy.
A higher percentage of positive reactions to manganese was found in patients with loosening of the prosthesis in cobalt-chromium-molybdenum (CrCoMo). It should be noted that the percentage of manganese in this alloy is very low, around just 1%.
It was also interesting to observe that the same group of patients with loosening of the CrCoMo implant was found to have a more frequent positive patch test to vanadium than the general population. This finding could be due to cross-reactivity to vanadium and other elements such as manganese. These results could confirm the assumption that it is the individual’s genetic predisposition that is responsible for sensitisation responses, rather than a concentration of the sensitising agent. In this study, patch testing was unable to discriminate between stable and loose implants.
However, implant loosening was observed to be 4 times more frequent in patients who reported symptoms associated with allergic reaction to metal before the knee replacement surgery. In conclusion, patients with a positive history of metal allergy should be assessed for possible sensitivity to the elements present in the metal alloys of knee implants.
Patch testing is a valid rapid screening exam for all the elements contained in current total knee replacement. Nonetheless, this does not rule out the possible need for more extensive in vitro diagnostic testing in doubtful cases or to confirm reactivity to a small number of elements.
NB: With respect to metal-allergic patients, an excellent solution might be found in the use of a ceramic femoral component combined with an “all-poly” polythene tibial component. This is the only type of coupling that will rule out the risk of implant elements triggering metal allergies. The use of new ceramic materials such as Biolox(R) delta (CeramTec AG, Stuttgart) appears to solve the structural limits posed by the fragile nature of ceramics, which currently requires fixation with bone cement.
There is also more on this page on the BoneSmart website
Re: Metal on Metal warning
The latest from the US of A on this subject - also gives some information on the sensitivity of metal ions:
Surgeon discusses rate, presentation of metal allergy in joint replacement
Although metal allergy with total joint replacement exists, the prevalence of this condition is unknown, according to Joshua J. Jacobs, MD.
“Metal allergy [with] orthopaedic implants has been well documented in isolated cases,” Jacobs said during his presentation at the American Academy of Orthopaedic Surgeons 2012 Annual Meeting/Orthopaedics Research Society symposium. “The true prevalence is unknown. Clinically significant symptomatologies seem to be rare in total knee replacements and metal-on-polyethylene total hip replacements, but much more common in metal- on-metal total hips.
Based on case reports and device literature, Jacobs said that metal allergy exists and has been seen as a temporal association. It can have different presentations and many involve a rash. In some examples, patients suffer skin reactions after implantation of total joint replacement devices. In other cases, the reaction goes away after the implant is removed for nonunion or refracture, only to return after re-implantation.
“In my mind, those sorts of cases prove to me that this is a real clinical entity,” Jacobs said.
Using patch testing, 14% of the general population would be sensitive to nickel and 10% would be sensitive to cobalt and chromium. However, Jacob said that patch testing may be flawed because it may have no bearing on what is occurring happening in deep tissues.
“Metal-on-metal allergy is the cause of clinical symptomatology, such as pain and swelling,” Jacobs said. These allergies present as skin reactions such as dermatitis, or patients may have a history of allergy to jewelry. The responses to these allergies can present as stiff knees, pseudotumors, necrosis or unexplained pain, Jacobs said.
“In patients with metal-on-metal surface replacements, there is a direct correlation between serum metal levels and metal sensitivity determined by [lymphocyte transformation testing] LTT,” Jacobs said. “Current diagnostic methods, both patch testing and in vitro, do require more robust clinical validation, but it can be useful in preop screening for patients with in vitro metal allergies when there is a history of reaction to jewellery.”
Jacobs JJ. Clinical manifestations of metal allergy. Adverse reactions to byproducts of joint replacements (AAOS/ORSI). Presented at the American Academy of Orthopaedic Surgery 2012 Annual Meeting. Feb. 7-11. San Francisco.
Josephine, I have an email into the surgeon's gatekeeper, as it were, so we will see on that front. I also independently emailed Zimmer but don't have a response yet. Soon I'll be dipping back into those old contacts. I'd be happy to private message you about my experience, but don't know how to do that here!
In the pdf, it does speak of a non-nickel device which is not yet on the market but who knows when that was written? I'll get back to him. I have his phone #
Josephine, thanks for your info. However, it poses a dilemma because it of course contradicts what I've been told by the manufacturer and surgeon so it appears I'm back to square 1. Let's see if I can get a consistent answer from someone at Zimmer or my surgeon's office who knows what they're talking about.
I posted a few days about concerns that the Zimmer persona implant I'm to receive contained nickel, as I have a nasty allergic reaction to it. None of the literature suggests that the implant has nickel, but it didn't say it DIDN'T have it, either -- always a warning sign.
A call to the manufacturer and my surgeon directly confirmed that parts of the implant do have nickel, but these more minor components can be swapped out by the manufacturer for those that do not for patients with nickel allergies. My surgeon has already ordered the implant with the non-nickel components.
Just FYI for fellow metal-allergy sufferers out there -- and many thanks to those who dug deep to help me resolve this issue. This forum is fabulous!
Josephine, thanks for your extensive reply and very good points. I understand what the trabecular metals do. (I should have prefaced my original post by saying that I've worked with academic medical center orthopedic surgeons and seen several dozen BTKR and TKR performed -- former career -- but I always find more insights from the average person who's been to the rodeo! But it has has been awhile.).
I've read the Zimmer website already, which is full of corporate doublespeak to a degree in that if its Persona implant were nickel-free, they'd be screaming it from the rooftops -- and they aren't. The implant was recalled earlier this year and some patients listed in the recall experienced severe metal implant allergies to the point of needing revision.
This implant will not be cementless as the surgeon said so himself; he doesn't believe in cementless for the reasons you pointed out. The Zimmer persona can be cemented according to the surgeon's preference and the patient's bone condition (details in the surgical overview directions on the Zimmer website -- and my doc believes 100% in cement for durability and healing. I'm simply looking for whether any nickel at all is within this implant -- which is strangely not discussed virtually anywhere.
Thank you very much for taking the time to reply with very good information! This forum is a godsend!
Hi and welcome to BoneSmart!
The Trabecular Metal™ Material is made of elemental tantalum (atomic number 73) which is one of the most chemically stable and biologically inert metals used in orthopaedic implants, making it highly biocompatible and corrosion-resistant. (quote from Zimmer site!) It is also only use in the coating that the bone grows into, not in the implant itself which might well contain nickel. However, I can find no mention of this yet but will continue looking and will also contact Zimmer.
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