Workshop on Nickel Dermatitis NACD & Implants Rosemont, IL 23 June 2016

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1 Rosemont, IL 23 June 2016 Kalman L. Watsky, M.D. Clinical Professor of Dermatology Yale School of Medicine Site Director, Dermatology Yale-New Haven Hospital, St. Raphael Campus

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3 In what way is patch testing important in relation to implanted devices? When is patch testing indicated? In what ways can patch testing affect clinical management?

4 In recent years, numerous case reports and small series have reported metal allergy associated with failure of primarily orthopedic implants. The current body of literature does not permit evidence based guidelines in the management of implant related metal hypersensitivity reactions (MHR).

5 In the US, there are >600,000 total knee arthroplasties and >420,000 total hip arthroplasties yearly; long term pain outcomes occur in ~9% after hip and ~20% after knee replacement. Estimates of MHR for implanted devices range from 0 to 5%. This is much lower than the 18.5% of patients found to be allergic to nickel alone in patients patch tested in Patients with failed implants have higher metal sensitivity rates.

6 The immunologic environment surrounding a metal implant is complex and incompletely understood; current evidence suggests Type IV reactions as the predominant type in MHRs. A proposed mechanism for metal implant aseptic joint loosening was proposed by Cadosch et al. (J BiomedMaterRes A 2010: 92: ). Osteoclasts are able to mature and proliferate on Ti and Al, leading to metal degradation, and uptake and eventual release of the Ti or Al ions. These osteolytic lesions may partially explain joint loosening.

7 Orthopedic implants are most commonly composed of metal alloys including stainless steel (primarily 316L which contains nickel, cobalt, and chromium), titanium alloys, including nitinol (55% nickel and 45% titanium), and oxidized zirconium. The exact constituents will vary by device and manufacturer.

8 Other metal containing devices with reported cases of MHR are used in gynecology (eg nickel or titanium containing devices used for fallopian tube occlusion), cardiology (eg stents and devices made of stainless steel and nitinol), and dentistry.

9 Changes consistent with a Type IV immunologic response have been documented in peri-implant reactions. Epicutaneous patch testing appears to be the best test for evaluation of potential metal or other reactions both pre- and post-implantation. A recommended protocol for patch testing using a baseline series and additional metal allergens based on implant composition was recently published. Testing with components of bone cement is also recommended; metal discs provided by manufacturers are not considered reliable for testing. The lymphocyte transformation test (LTT) is rarely endorsed as an alternative or supplement to patch testing by dermatologists, though it may have a future role. Hypersensitivity reactions to metallic implants diagnostic algorithm and suggested patch test series for clinical use. Schalock PC, Menne T, Johansen JD, et al. Contact Dermatitis 2012;66:4-19.

10 In the US, pre-implant testing is only recommended for patients who give a history of reactions to metals though screening for nickel allergy is recommended for all patients undergoing Nuss bar surgery for pes excavatum (a study showed that 6.4% of patients tested had nickel allergy leading to use of a titanium rod). European groups rarely recommend any pre-implantation testing. Use of titanium or oxidized zirconium is recommended for patients with a question of metal sensitivity who do not undergo pre-implant testing.

11 Reactions to implanted devices are uncommon, even in patients who receive a device with a metal to which they have documented sensitivity. No testing is indicated for patients who are symptom free after implantation. There are many reports of chronic pain, skin reactions, and aseptic joint loosening or implant failure in patients who prove to be allergic to metals in their implanted device. There are outcome studies examining post-implant testing that show some benefit, though they are of small size and poorly controlled. Published guidelines exist classifying those patients who may benefit from post-implant testing using major and minor criteria.

12 In most situations, deliberately implanting a material to which someone is allergic is not ideal, and will make the best option a suboptimal option. Illustrative of this point were patients examined in a retrospective case control study prior to total hip replacement and symptomatic and asymptomatic individuals after total hip replacement. Those with positive patch test reaction(s) to metals and a history of metal hypersensitivity had significantly shorter lifespans of their implants. Of individuals with positive test(s) for bone cement components, none had a stable implant at a 10-year endpoint (J BiomedMater Res B Appl Biomater 2006: 77: ). These findings have not been confirmed in a prospective study.

13 Proposed management algorithm following positive patch testing in patients with orthopaedic implants. Schalock PC, Menne T, Johansen JD, et al. Contact Dermatitis 2012;66:4-19 PTFE: polytetrafluoroethylene

14 A positive patch test result (an immunological process) is not necessarily relevant to a clinical disease process (allergic contact dermatitis and symptoms such as joint loosening). Do not make management decisions on the basis of a positive test result alone. The questions around MHR and joint or other device failure persist. Larger and better controlled studies are needed along with further research to help clinicians and patients faced with this challenge.

15 A 30yo woman with a hx of reactions to costume jewelry developed dermatitis on her lower back 2 weeks after spinal fusion with a titanium implant. Patch testing showed allergy to Ni, lanolin, triclosan, fragrance mix II, palladium, copper, & benzoyl peroxide but not to titanium. Final dx: Most likely allergic contact dermatitis to prep solution or dressing materials.

16 An 84yo woman presents with a persistent dermatitis following THR. Patch testing positive for gold; not relevant. Final dx: stasis change related to prior surgery.

17 PATCH TESTING FOR ORTHOPAEDIC AND OTHER IMPLANTED DEVICES: BONE CEMENT Andreas Bircher, Niklaus F. Friederich, Walter Seelig and Kathrin Scherer. Allergic complications from orthopaedic joint implants: the role of delayed hypersensitivity to benzoyl peroxide in bone cement. Contact Dermatitis doi: /j x Potential bone cement allergens: acrylates, benzoyl peroxide, N,N-dimethyl-p-toluidine, & gentamycin 5 patients with complications from knee or shoulder joint implantation are reported in whom allergy to benzoyl peroxide was demonstrated by patch testing A bone cement-free replacement was chosen for these sensitized patients In 4/5 patients, the replacement led to a decrease or disappearance of pain & swelling and complete clearing of dermatitis. Haddad F S, Cobb A G, Bentley G, Levell N J, Dowd P M. Hypersensitivity in aseptic loosening of total hip replacements. The role of constituents of bone cement. J Bone Joint Surg Br 1996: 78: /15 patients with early aseptic loosening of cemented total hip replacements had positive patch tests to N,Ndimethyl-p-toluidine Clementi D, Surace A, Celestini M, Pietrogrande V. Clinical investigations of tolerance to materials and acrylic cement in patients with hip prostheses. Ital J Orthop Traumatol 1980: 6: % of THR patients had positive patch tests to methyl methacrylate 6 months after implantation

18 PATCH TESTING FOR ORTHOPAEDIC AND OTHER IMPLANTED DEVICES: OUTCOMES The Effect of Patch Testing on Surgical Practices and Outcomes in Orthopedic Patients With Metal Implants Mesinkovska NA, Tellez A, Molina L, et al. Arch Dermatol. 2012;148(6): doi: /archdermatol Objective: To determine the effect of patch testing on surgical decision making and outcomes in patients evaluated for suspected metal hypersensitivity related to implants in bones or joints. Main Outcome Measures: The surgeon s preoperative choice of metal implant alloy compared with patch testing results and the presence of hypersensitivity complications related to the metal implant on postsurgical follow-up. Continued on next slide

19 PATCH TESTING FOR ORTHOPAEDIC AND OTHER IMPLANTED DEVICES: OUTCOMES Results: Patients with potential metal hypersensitivity from implanted devices (N=72) were divided into 2 groups depending on timing of their patch testing: preimplantation (n=31) and postimplantation (n=41). History of hypersensitivity to metals was a predictor of positive patch test results to metals in both groups. Positive patch test results indicating metal hypersensitivity influenced the decision making process of the referring surgeon in all preimplantation cases (n=21). Patients with metal hypersensitivity who received an allergen-free implant had surgical outcomes free of hypersensitivity complications (n=21). In patients who had positive patch test results to a metal in their implant after implantation, removal of the device led to resolution of associated symptoms (6 of 10 patients). Conclusions: The findings of this study support a role for patch testing in patients with a clinical history of metal hypersensitivity before prosthetic device implantation. The decision on whether to remove an implanted device after positive patch test results should be made on a case-by case basis, as decided by the surgeon and patient. Arch Dermatol. 2012;148(6):

20 In what way is patch testing important in relation to implanted devices? Patch testing can help guide choice of materials and aid in diagnosis in the case of certain post-implant complications. When is patch testing indicated? Pre-implantation in cases of suspected metal sensitivity and post-implant in the event of skin reactions, chronic pain, joint loosening, or implant failure absent other causes. In what ways can patch testing affect clinical management? Known metal sensitivity can impact choice of implant in advance of surgery; comprehensive testing post surgery in cases of complications may affect surgical choices, including implant removal and replacement with an allergen-free device.