Original Title: Dosage sanguin du titane par spectrométrie de masse à plasma à couplage inductif (ICP-MS)

Authors' objectives: A request to introduce a new test to the Répertoire québécois et système de mesure des procédures de biologie médicale (hereinafter referred to as the “ Répertoire ”) has been submitted to the Institut national d'excellence en santé et en services sociaux (INESSS), in accordance with the evaluation mechanism for new medical biology tests. The mandate given was to evaluate blood titanium levels as part of the management of toxicities potentially associated with this metal, particularly in the case of orthopedic surgery or occupational exposure. As this test is not listed in the Répertoire, the Ministère de la Santé et des Services sociaux (MSSS) considers it necessary to evaluate the relevance of this test from a provincial perspective.

Authors' results and conclusions: RESULT: (#1 SOCIO-CULTURAL DIMENSION): The national and international regulatory agency documents reviewed do not contain recommendations for titanium ion testing in patients undergoing metal-on-metal hip arthroplasty, nor do they provide information on a reference threshold in blood. They state that no evidence has been found to demonstrate an association between high titanium concentrations and any adverse effects occasionally observed. Only the FDA (Food and Drug Administration) has reported that patients with metal-on-metal hip implants may have elevated levels of titanium metal ions in their blood, without providing reference exposure thresholds for this metal. In Quebec, to date, no recommendations or guidelines for titanium blood testing have been produced. (#2 POPULATION DIMENSION): Titanium testing is currently conducted outside Quebec, and most requests come from orthopedists, mainly for suspected metallosis. Clinicians report that metallosis is rare but undermines people's quality of life. It is mostly confirmed by medical imaging and often leads to surgical revision. Some clinicians mentioned that titanium testing could be considered as part of a diagnosis of exclusion, following confirmation of metallosis by physical examinations and imaging results. Others believe testing could be used for research purposes, particularly for overexposed workers. (#3 CLINICAL DIMENSION): A search of the scientific literature identified two observational cohort studies and two case reports with findings on a possible association between elevated blood titanium levels and systemic toxicities, as well as the validation of a reference range for titanium ions in patients with functional hip implants. The results suggest that elevated blood titanium levels can be observed in patients with certain surgical implants. This rise in blood titanium ions could be indirectly linked to systemic and neurological toxicities. These toxicities remain rare, and merit further research to better identify risk and protective factors. No studies on the occurrence of toxicities following occupational exposure to titanium have been identified. (#4 ORGANIZATIONAL DIMENSION): According to the MSSS, the CTQ would be the only laboratory designated to perform titanium testing by inductively coupled plasma mass spectrometry, should it be included in the Répertoire. The CTQ stated that it had the human and material resources required to respond to the provincial request within two weeks. The clinicians consulted agreed with the proposed timeframe. Should the test be added to the Répertoire, it is reasonable to assume that the volume will be higher than that currently performed outside Quebec.(#5 ECONOMIC DIMENSION): The effectiveness of the recommended test cannot be accurately evaluated, given that clinical outcomes and costs cannot be adequately measured or approximated. The weighted value of this analysis is 62.88. The introduction of the recommended test in the Répertoire could, over the first 3 years, generate savings of $45,672 under the lower scenario, or costs of $149,570 under the higher scenario.

Authors' recommendations: Based on the findings of the five value dimensions, which highlight the rarity of titaniumrelated toxicities in orthopedics at the provincial level, or those of occupational origin with no established cause-and-effect relationship in patients, given the absence of a reference threshold for interpreting titanium blood test results, and the weakness of scientific data supporting the clinical usefulness of such a test, the INESSS considers that there is insufficient evidence currently to recommend the inclusion of a titanium blood test in the Répertoire.

Authors' methods: To answer the evaluation questions, a rapid review of the scientific literature was conducted, based on publications listed in bibliographic databases and other information sources. Consultations were also held with clinicians and other stakeholders. The methodology was based on nine evaluation questions covering the five dimensions of the INESSS framework for evaluating the value of interventions. A budgetary impact analysis was conducted, considering the costs associated with the introduction of titanium blood levels testing in the Répertoire. Costs were projected over a three-year time period from the perspective of the healthcare system. All the scientific, contextual and experiential data were interpreted and synthesized into findings to guide the analysis process by the Internal Expertise Committee, in order to make recommendations.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-du-titane-par-spectrometrie-de-masse-a-plasma-a-couplage-inductif-icp-ms.html

Year Published: 2024

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-du-titane-par-spectrometrie-de-masse-a-plasma-a-couplage-inductif-icp-ms.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)