Trial reportActa orthopaedica2014
Metal release and metal allergy after total hip replacement with resurfacing versus conventional hybrid prosthesis.
Trial report in Acta orthopaedica, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Pooled it
- Existing and Novel Assessment Methods for Metal Sensitivity in Elective Lower-Limb Arthroplasty-A Scoping Review.Arthroplasty today · 2024Article
- Understanding immune-mediated cobalt/chromium allergy to orthopaedic implants: a meta-synthetic review.Arthroplasty (London, England) · 2024Review
- Serum cobalt and chromium concentration following total hip arthroplasty: a Bayesian network meta-analysis.Scientific reports · 2023Article
- Lymphocyte transformation test reveals low prevalence of true metal hypersensitivity among pre-operative total knee arthroplasty patients.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2022Article
- Nickel hypersensitivity and skin patch testing in total hip replacement surgery: a systematic review.EFORT open reviews · 2021Review
- Fragility Index as a Measure of Randomized Clinical Trial Quality in Adult Reconstruction: A Systematic Review.Arthroplasty today · 2021Article
- Long-term outcome after implantation of a nickel-containing cemented hip stem on the right in a patient with type IV sensitization to nickel sulphate.GMS Interdisciplinary plastic and reconstructive surgery DGPW · 2019Article
- Specifications for Innovative, Enabling Biomaterials Based on the Principles of Biocompatibility Mechanisms.Frontiers in bioengineering and biotechnology · 2019Article
- Article
- Allergic Sensitization to Nickel and Implanted Metal Devices: A Perspective.Dermatitis : contact, atopic, occupational, drugArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMetal-on-metal (MOM) total hip arthroplasties were reintroduced because of the problems with osteolysis and aseptic loosening related to polyethylene wear of early metal-on-polyethylene (MOP) arthroplasties. The volumetric wear rate has been greatly reduced with MOM arthroplasties; however, because of nano-size wear particles, the absolute number has been greatly increased. Thus, a source of metal ion exposure with the potential to sensitize patients is present. We hypothesized that higher amounts of wear particles result in increased release of metal ions and ultimately lead to an increased incidence of metal allergy.
methods52 hips in 52 patients (median age 60 (51-64) years, 30 women) were randomized to either a MOM hip resurfacing system (ReCap) or a standard MOP total hip arthoplasty (Mallory Head/Exeter). Spot urine samples were collected preoperatively, postoperatively, after 3 months, and after 1, 2, and 5 years and tested with inductively coupled plasma-sector field mass spectrometry. After 5 years, hypersensitivity to metals was evaluated by patch testing and lymphocyte transformation assay. In addition, the patients answered a questionnaire about hypersensitivity.
resultsA statistically significant 10- to 20-fold increase in urinary levels of cobalt and chromium was observed throughout the entire follow-up in the MOM group. The prevalence of metal allergy was similar between groups.
interpretationWhile we observed significantly increased levels of metal ions in the urine during the entire follow-up period, no difference in prevalence of metal allergy was observed in the MOM group. However, the effect of long-term metal exposure remains uncertain.
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Registered trials
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