Table 5 Prevalence of Nickel hypersensitivity across the studies together with relevant clinical outcomes for each population (e.g. complications, status of implant, further management etc.)
Study | Timing of testing | Population | Sample size (n) | Nickel hypersensitivity | Clinical results (e.g. complications, status of implant, further management etc.) | ||
|---|---|---|---|---|---|---|---|
No. patients | Proportion | ||||||
Atanaskova Mesinkovska et al. [24] | Preoperatively | Before implantation of an orthopedic metal device | 31 | 16a | 52.0% | Patients with metal hypersensitivity received a hypoallergenic implant and developed no complications attributable to hypersensitivity at time of follow-up | |
Postoperatively (median follow-up 21 months, range 1–232) | After implantation of an orthopedic metal device | 41 | 10a | 24.0% | 6 out of 10 patients with positive patch test to a metal in their implant had the prosthesis removed leading to resolution of symptoms. The other 4 patients did not undergo revision surgery and continued to experience symptoms. | ||
Carlsson and Möller [25] | Postoperatively (mean follow-up 6.3 years, range 1 to 16 years) | Patients with contact allergy to Chromium, Cobalt and/or Nickel (verified by patch test preop) followed up after implantation of various metallic orthopedic devices (3 TKA, 15 other orthopedic implants) containing metal to which they were allergic c | 18 | 15a/b | 83.3% | No patients developed dermatologic or orthopedic complications attributable to contact allergy | |
Carossino et al. [28] | - | Control group—no implant, no skin/immunological/metabolic or chronic disease | 9 | NR | NR |  | |
Preoperatively | Patients awaiting TKA with documented clinical history of metal allergy and hypersensitivity reactions | 8 | 7 | 87.5% | Patients underwent TKA with hypoallergenic implant and had no complications at 12-month post-op review. | ||
Postoperatively (after at least 6Â months) | Patients with painful TKA with referred metal allergy | 11 | 6 | 54.5% | 7 out of 11 patients underwent revision arthroplasty with Nickel-free implant and were free of symptoms and complications at 12-month post-op review. | ||
Postoperatively (after at least 6Â months) | Patients with painful TKA without referred metal allergy or signs of sensitisation | 11 | 2 | 18.0% | Treated as non-hypersensitive: 3 patients underwent second procedure with Nickel-free implant and pain disappeared. The other patients were treated with analgesics and steroids and had persistent symptoms and variable joint function. | ||
Desai et al. [29] | Postoperatively (after at least 3 months) | TKA patients at least 3 months post-op | 233 | 20 | 8.6% | Patch test positive patients (to all metals) (n = 37): 6 patients – pain (P = 0.17) 5 patients – loss of function (P = 0.03) 5 patients – patient dissatisfaction (P = 0.01) | |
Frigerio et al. [30] | Preoperatively | Before TJA (knee or hip) | 100 | 21a | 21.0% | 5 patients with initial negative test (PT or LTT) for MHS became positive postoperatively – 4 were Nickel positive (3 patch test, 1 LTT) 1 patient reported pain without radiographic evidence of implant loosening: No other patients developed cutaneous signs attributable to metal hypersensitivity or implant loosening after TKA or THA. | |
Postoperatively (after 1Â year) | After TJA (knee or hip) | 72 | 3b | 4.2% | |||
Granchi et al. [7] | Preoperatively | Control group = no implant, candidates for TKA | 20 | NR | 10.0% |  | |
Postoperatively (median follow-up 18 months, range 9.6–120) | Stable TKA | All | 27 | NR | 7.4% |  | |
With clinical symptoms i.e. pain | 14 | NR | 7.1% | Â | |||
without clinical symptoms i.e. no pain | 13 | NR | 7.7% | Â | |||
Postoperatively (median follow-up 24 months, range 4.8–132) | Loosened TKA | All | 47 | NR | 23.4% |  | |
Aseptic loosening | 21 | NR | 23.8% | Â | |||
Septic loosening | 17 | NR | 35.3% | Â | |||
Mechanical failure | 9 | NR | 0.0% | Â | |||
Guenther et al. [31] | NR | Primary and revision knee and hip arthroplasty patients from historic database | 34,914 | 849 | 2.4% | Â | |
Postoperatively (mean follow-up 2 years) | Historic database patients with pre-operatively known sensitisation to Chromium, Cobalt, Nickel, or cement component who underwent revision knee (n = 14) and hip (n = 3) arthroplasty due to a potential allergic reaction c | 17 | 13a | 76.5% | In TKA patients with likely allergic reactions, Hospital for Special Surgery score (HSS) increased following revision with hypoallergenic coated implants. | ||
Innocenti et al. [32] | Preoperatively | Patients with referred or suspected metal allergy before TKA with a hypoallergenic implant | 24 | 21 | 87.5% | All patients underwent TKA with a hypoallergenic implant. Mean follow-up was 79.2 months (range 61–90). No patients reported any hypersensitivity-related reaction, pain or failure of implant. Postop had improved VAS, KSS and functional score. | |
Kitagawa et al. [26] | Preoperatively | Before TKA | 48 | 3 | 6.3% | Â | |
Postoperatively (after 6Â months) | After TKA with CoCr implant | 25 | 0b | 0.0% | Both groups showed improved knee score and functional score postoperatively. No clinical or radiological complications observed in either group at 5-year follow up. | ||
Postoperatively (after 6Â months) | After TKA with OxZr implant | 22 | 2 (0b) | 9.1% (0%) | |||
Kręcisz et al. [27] | Preoperatively | Before TJA (knee [n = 21] or hip [n = 39]) | 60 | 12a | 20.0% | Patients with confirmed metal allergy preoperatively received implants without sensitising metal, and none developed complications or symptoms postoperatively | |
Postoperatively (after 24 months) | After TJA (knee or hip) | 48 | 10a/b | 20.8% | 5 patients with newly positive reaction to metal were symptomatic:  3 patients – recurrent pain, swelling and erythema  2 patients – symptoms of metal dermatitis | ||
Lützner et al. [42] | Preoperatively | Before TKA with coated (hypoallergenic) implant | 61 | NR | NR | No patients developed skin reactions or complications with their implant. | |
Preoperatively | Before TKA with standard implant | 59 | NR | NR | |||
Postoperatively (after 1Â year) | After TKA with coated (hypoallergenic) implant | 60 | 1 'doubtful' reactionb | 1.7% | |||
Postoperatively (after 1Â year) | After TKA with standard implant | 56 | 1 'doubtful' reactionb | 1.8% | |||
Sasseville et al. [33] | Postoperatively (mean follow-up 29.1Â months, SD 20.1) | Postop TKA patients with complications | 39 | 4 | 10.3% | 1 PT positive patient underwent revision with 'ceramic' implant and had persistent asymptomatic erythema over knee. 1 PT positive patient underwent revision with titanium implant and had complete remission. 1 PT and LTT positive patient underwent revision with titanium implant and had significant improvement in symptoms. 1 PT and LTT positive patient underwent revision with titanium implant and had no improvement. | |
Tam et al. [34] | Preoperatively | Patients referred for evaluation of MHS before implantation of orthopedic (n = 21), cardiovascular (n = 7), dental (n = 8) and other (n = 4) devices (12 TKA patients) | 40 | 17a | 42.5% | Patients with relevant metal hypersensitivity who underwent revision surgery had complete resolution or improvement of their symptoms, whereas those with metal hypersensitivity who did not undergo revision surgery had persistent symptoms. | |
Postoperatively (time frame NR) | Patients referred for evaluation of MHS after implantation of orthopaedic (n = 49), cardiovascular (n = 4), dental (n = 28) and other (n = 6) devices (27 TKA patients) | 87 | 14 (6 out of 49 orthopedic implantsa) | 16.10% (12.2% of orthopedic implants) | |||
Thomas et al. [35] | Postoperatively (time frame NR) | TKA patients with yet unexplained complications (loosening, recurrent effusions, and pain) | 25 | 10 | 40.0% | 8 out of 9 patients who underwent revision with hypoallergenic implant reported symptom relief. | |
- | "OA-control group" = OA patients awaiting TKA | 12 | NR | NR | |||
- | "PT-control group" = patients without implant but having undergone patch testing for suspected skin allergy | 8 | NR | NR | |||
Thomas et al. [36] | NR | Patients within study population who had been patch tested in the past for several reasons | 48 | 13a | 27.1% | Â | |
Postoperatively (time frame NR) | TKA (n = 189) and THA (n = 61) patients suspected of having allergic reactions with complaints of pain (90.5%), reduced ROM (74%), swelling (67.5%), effusions (29%), loosening (16.5%) and eczema (5.5%) | 250 | 32a/b | 12.8% |  | ||
Thomas et al. [37] | - | Patients with eczema without metal implant, no CMI | 30 | 0 | 0.0% | Â | |
- | Patients with eczema without metal implant, with CMI | 38 | 13 | 34.2% | Â | ||
Postoperatively (time frame NR) | TKA (n = 47) and THA (n = 53) patients without symptoms/complications | 100 | 9a | 9.0% |  | ||
TKA (n = 187) and THA (n = 13) patients with symptoms/complications (Pain, effusion, eczema, loosening, reduced ROM) | 200 | 35a | 17.5% |  | |||
Treudler and Simon [38] | Postoperatively (average follow-up NR, range 6–36 months) | TKA patients with suspicion of contact allergy to implant material | 13 | 1 | 7.7% | The one patient with Nickel hypersensitivity reported pain and palmar eczema. | |
Verma et al. [39] | Postoperatively (time frame NR) | TKA patients with eczema surrounding the knee | 15 | 4 | 26.7% | All patients were treated with topical corticosteroid resulting in clearing of eczema within 2Â weeks. There was no recurrence of eczema or implant complications. | |
Webley et al. [40] | Postoperatively (mean follow-up 2.7 years, range 1–5 years) | Control group = patients with rheumatoid arthritis or osteoarthritis without prostheses | 33 | NR | NR |  | |
Patients with hinge arthroplasty of the knee investigated for possible metal sensitivity | 50 | 5 | 10.0% | 33/50 patients—No complications (10 patients had positive PT) 7/50 patients—Loosening (1 patient had positive PT) 10/50 patients—Discharge (5 patients had positive PT) | |||
Zeng et al. [41] | Preoperatively | Before TKA | 29 | NR | 7.2% | Â | |
Before THA | 67 | NR | 15.5% | ||||