Thank you for your recent inquiry.
Unfortunately there is no Practice Parameter or Guideline, to my knowledge, dealing with this area. I could not find such Guideline utilizing a literature search. Therefore, with the lack of a Guideline I cannot give you a definitive answer to your question. Some insight may be gained, however, by looking at two previous responses that the "Ask the Expert" site has given to previous submitted similar questions. One of these responses was from Dr. Burt Zweiman, who managed the website before I started, and the other response is from me. They each contain references in the form of abstracts that deal with the issue.
In addition, I have copied below a reference dealing with cement allergy that is available at no charge online. It discusses the issue of delayed hypersensitivity reactions to cement and presents a case report. It is a nice concise review of the literature in this regard.
The bottom line, however, is that, at least to my knowledge, there is no standardized procedure, and how one attacks this is up to their clinical judgment. I believe that the panel that you used for testing is superb. I think cement could easily be added to this panel.
In addition, we often write the manufacturer for a patch test kit. Many manufacturers have such a kit, and this makes the job a lot easier.
Thank you again for your inquiry and we hope this response is helpful to you.
"I've been getting requests from some ortho surgeons to patch test essentially all pts before ortho implant. I can't find any good references regarding whether testing is indicated in a patient without any history of contact derm due to metal or other contact allergen. Thanks.
Answer from Dr. Phil Lieberman:
Thank you for your recent inquiry. As far as I am aware, it is not standard practice to patch test "preemptively" before the insertion of metal implants. In my experience, this is usually done only when there is a previous history of possible contact dermatitis to the metal in question or on occasion when patients have developed a dermatitis after implantation. However, there are studies that have evaluated prospective patch testing prior to implantation. For your interest, I have copied a couple of these abstracts below.
Should you wish to conduct prospective patch testing, you can sometimes obtain patch test kits from the manufacturer of the implant. Also metals for patch testing are available from certain suppliers. Listed for you below are three such suppliers:
Chemotechnique Diagnostics (Malmo, Sweden); www.chemotechnique.se
Hermal (Reinbek, Germany); www.hermal.de
Brial Allergen (Greven, Germany); www.brial.com
The decision to do prospective patch testing, of course, would be based upon individual judgment. At this time, at least from my perusal of the literature, it would not be standard, but at least based on one of the abstracts copied below, such testing can be helpful.
Thank you again for your inquiry and we hope this response is helpful to you.
Arch Dermatol. 2008 Aug;144(8):999-1007.
Retrospective evaluation of patch testing before or after metal device implantation.
Reed KB, Davis MD, Nakamura K, Hanson L, Richardson DM.
College of Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA.
Comment in: Arch Dermatol. 2008 Aug;144(8):1042-4.
OBJECTIVE: To review the results of patch testing before or after metal device implantation. DESIGN: Retrospective medical chart review. SETTING: Tertiary care academic medical center. PATIENTS: All patients who underwent patch testing before or after metal device implantation. INTERVENTIONS: Patch testing. RESULTS: From January 1999 through March 2006, 44 patients underwent patch testing in conjunction with metal device implantation, 22 preoperatively and 22 postoperatively. The reason for preoperative patch testing was a history of allergy to metals. Five patients had positive results for a component of the proposed device. The reasons for postoperative patch testing were unexplained skin eruptions at the implantation site (13 patients), chronic joint pain (8 patients), and joint loosening (1 patient). None of the patients had positive patch test results to a component of the previously implanted device. CONCLUSIONS: Although the numbers of patients in this study were small, patch testing performed before metal device implantation was helpful in guiding the choice of device selected. Patch testing after implantation was of limited value.
Zentralbl Chir. 1998;123(11):1271-6.
[Prospective study of the significance of contact sensitization caused by metal implants]
[Article in German]
Duchna HW, Nowack U, Merget R, Muhr G, Schultze-Werninghaus G.
Abt. f. Pneumologie, Allergologie und Schlafmedizin, Ruhr-Universität Bochum. Hans-Werner.Duchna@ruhr-uni-bochum.de
INTRODUCTION: Allergies caused by metallic implants are often thought to be a reason for postoperative complications like bone necrosis or loosening of the prosthesis. PATIENTS AND METHODS: In a prospective study, we investigated allergic sensitivity against components of stainless steel implants, including titanium, in 112 patients shortly before surgical operation. The same tests were then repeated in 100 of these patients exactly one year after operation. There were three different kinds of procedures: 1. titanium implants, mainly total hip replacements, 2. regular steel implants, 3. surgery without any implants (control group). Any differences from the process of regular healing were regarded as postoperative complications. RESULTS: A sensitivity against nickel (Ni) was diagnosed in three of these 100 patients (3%) before surgery. These patients, of whom two received a nickel-containing implant and one a titanium arthroplasty, did not show any postsurgical complications. Furthermore, three patients (3%) acquired a new sensitivity against metals during the study-interval of one year. Two of these three patients were women, who developed a postsurgical sensitivity against nickel or chrome but got titanium arthroplasties, which did not contain any nickel. These two women wore metal-containing jewelry, which might be the reason for the newly acquired metal-sensitivities, and both showed postsurgical complications. The third patient, who has developed a postsurgical sensitivity against components of his steel arthroplasty, did not reveal any complications. DISCUSSION: We conclude that the rate of allergic sensitization against metal-components of arthroplasties is low in our patients. Additionally, skin-sensitivity against components of alloys and platings was not associated with a higher rate of postsurgical complications in our patients. We did not see any sensitivity against titanium. In conclusion, metallic implants are not a cause of allergies to a relevant extent, nowadays"
Do you have any articles or information regarding metal allergy to a hip replacement? Metal to include nickel, cobalt, titanium, chromium.
Answer from Dr. Burt Zweiman:
I discussed your question with the former Chief of the Hip Surgery service in the Orthopedics Dept of our medical center. He pointed out that the question of sensitivity to metallic components released from the prostheses during wear and tear used to be discussed frequently when such prostheses were almost always made of metal on metal. However, when metal on plastic prostheses essentially replaced the metal on metal type, the incidence of suspected sensitization decreased considerably. Ceramics were also being used more in such prostheses. However, local irritative problems secondary to the breakdown within the plastic components of prostheses have stimulated the return to metal on metal prostheses in some centers. The metal currently used is more resistant to wear and tear and is composed mainly of titanium with nickel and chromium. As noted in the enclosed abstract, it is uncertain how often sensitization to metallic components will occur with these newer prostheses. Older studies suggested an association of positive parch tests to metallic ions with premature loosening/failure of hip prostheses (see enclosed abstract). However, some more recent studies have not found such an association. My personal impression is that the value of patch testing for metal sensitivity in such patients is still uncertain.
Br J Dermatol. 2003 Jun;148(6):1089-93.
Related Articles, Links
Metal sensitivities and orthopaedic implants revisited: the potential for metal allergy with the new metal-on-metal joint prostheses.
Gawkrodger DJ. Department of Dermatology, Royal Hallamshire Hospital , Sheffield S10
The potential of metal-containing orthopaedic prostheses to induce problems through metal allergy taxes dermatologists and orthopaedic surgeons alike. Metal-on-plastic joint replacements are not thought to induce metal allergy but wear products, principally polypropylene particles, produce a foreign body reaction in bone and may lead to aseptic loosening of the joint. Orthopaedic surgeons are increasingly using metal-on-metal joint replacements, particularly for younger patients, as some evidence suggests that there is less wear debris and hence less aseptic loosening. The original metal-on-metal hip joints of the 1960s were associated with sensitivities to cobalt, nickel and chromate when loosening occurred. The potential for modern metal-on-metal joint prostheses, with their lower production of wear debris, to sensitize the recipient to metals or to induce a problem in subjects already allergic to metals, is unclear. One uncontrolled series suggested an association between nickel allergy and prosthesis loosening in some subjects, but the question has yet to be addressed in a prospective study and to date there is no other observation in the orthopaedic literature to suggest a problem
Br Med J. 1975 Nov 15;4(5993):376-8.
Related Articles, Links
Incidence of metal sensitivity in patients with total joint replacements.
Elves MW, Wilson JN, Scales JT, Kemp HB.
Sensitivity to chromium, cobalt, nickel, molybdenum, vanadium, and titanium was studied by patch tests in 50 patients who had received total joint replacements. Nineteen (38%) were sensitive to one or more of the metals. In 23 patients non-traumatic failure of the prosthesis had occurred, and 15 of these patients were sensitive to metal. Out of 27 patients with no evidence of prosthesis loosening, four were sensitive to nickel and cobalt or nickel only. Dermatological reactions occurred in 13 patients after surgery; in only eight, however, was there evidence of metal sensitivity. These findings indicate that metal-on-metal total joint replacements may sensitize the patient to metals contained in the prosthesis. Although there is a high incidence of prosthesis failure among metal-sensitive patients it remains uncertain whether the loosening causes the sensitization or vice versa.
ORTHOPEDICS July 2008;31(7):708.
Hypersensitivity to Polymethylmethacrylate Following Shoulder Hemiarthroplasty
by LT Jonathan Erpenbach, MD; CDR Eric Hofmeister, MD
Phil Lieberman, M.D.
Key Words: patch tests, orthopedic prosthesis, metal allergy