Review Article

Biomaterial Hypersensitivity: Is It Real? Supportive Evidence and Approach Considerations for Metal Allergic Patients following Total Knee Arthroplasty

Table 1

Hypersensitivity reactions after total joint arthroplasty reported in prospective studies.

Prospective study titlePublicationAuthorResults

Sensitivity to implant materials in patients undergoing total hip-replacementJ Biomed Mater Res Granchi et al. [19]Patch test unable to differentiate stable versus unstable implants, equivalent implant lifespan in metal patch +; 10 yr survival for metal patch + 44% versus patch − 47%; poor survival for cement patch +
Allergy to components of total hip arthroplasty before and after surgeryItal J Orthop TraumatolCancilleri et al. [20]10/66 THA patch + (1/12 w/aseptic loosening patch +), 2/41 preop. patch +; hypersensitivity may play role in loosening, but likely small
Metal sensitivity in patients with metal-to-plastic total hip arthroplastiesActa Orthop ScandCarlsson et al. [11]9/112 patch + preop., 12/112 patch + postop.; all complications except 1/246 explained by reasons other than hypersensitivity
Allergy in hip arthroplastyContact DermatitisWaterman and Schrik [21]13/85 patch + preop. (13 metal), 25/85 patch + postop. (23 metal, 2 cement), 0/10 loose THA patch +; no evidence to suggest loosening because of hypersensitivity
The development of metal hypersensitivity in patients with metal-to-plastic hip arthroplastiesContact DermatitisNater et al. [22]0/66 patch + preop., 4/66 patch + MOP conversion postop.; no clinical sequelae, no need to test
Metal sensitivity in patients with orthopedic implants: a prospective studyContact DermatitisFrigerio et al. [6]16/72 (22%) preop. + patch or LTT, (19/72 (29%) postop. (5 conversions of 72 total)); if preop. history insufficient, recommend for screening tests
Metal sensitivity before and after total hip arthroplastyJ Bone Joint Surg AmDeutman et al. [23]10/173 patch + preop., 4/66 converted patch + postop. MOP; no conclusion
Metal sensitivity in patients undergoing hip-replacementJ Bone Joint Surg BrRooker and Wilkinson [10]6/69 patch + preop. MOP, only 1/54 patch + postop.; patch + may be effect not cause, no need to screen in MOP
The effect of patch testing on surgical practices and outcomes in orthopedic patients with metal implantsArch DermatolMesinkovska et al. [9]31 with history of hypersensitivity preop., 21 patch +, all did well with “allergen-free” implants; 41 suspected of hypersensitivity w/TJA, 10 patch +, 6/10 had resolution of symptoms with allergen free implant; recommend patch testing in those with history
Screening for symptomatic metal sensitivity: a prospective study of 92 patients undergoing total knee arthroplastyBiomaterialsNiki et al. [24]24/92 TKA were mLST+ preop., 5/24 developed eczema, Cr + in eczema patients but not in others; screening indicated

Prospective study summaryPreop. patch/LTT +: 56/618 (9.1%), postop.: 73/521 (14.1%)
Conversion of patch/LTT preop. to postop.: 56/618 (9.1%) preop. versus 73/521 (14.0%) postop.