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Article History

Received: 3 March 2022

Accepted: 23 May 2022

First Online: 4 June 2022

Declarations

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: The study was previously approved, with the waiver of the free and informed consent form, by the Ethics and Research Committee of the Federal University of São Paulo (UNIFESP) under the number: 0846P/2021. In addition, we confirm that all methods were performed in accordance with the relevant guidelines and regulations currently available.Waiver of consent justification Patient consent was waived by the local IRB for this observational study because involved in minimal risk to the subject due to the anonymization of patients’ data and meets specific criteria during the COVID-19 pandemic period. The reasonable rationale for why the research would not be possible without the waiver is stated below:1. The need to carry out only online consultation follow-up, made it difficult to obtain many patients’ consents, as social distance was mandatory during this period.2. Fracture-related infection diagnosis is usually performed months after surgery, and many patients were contacted online or even by telephone, hindering the possibility to obtain a signed informed consent.3. The research could not practicably be carried out without waiver, as involved more than 100 non-infected patients.4. Part of this cohort study is retrospective because existing data, specimens and medical records were available and analysed as of the date of IRB submission.5. The research could not practicably be carried out without using identifiable private information and biospecimens in an identifiable format.6. The waiver will not adversely affect the rights and welfare of the subjects.7. Inability to identify subjects that is likely to evolve to fracture-related infection, which may occur from the emergency admission to months after the surgical procedure. Therefore, the study staff can't plan for coverage to obtain consent.8. The study involved more than 100 patients undergoing any type of surgery for fracture stabilization, which has been physically impossible to obtain consent from them all.9. The number of patients with FRI was small (21) and removing any subject due to the impossibility to obtain the consent or even those refusing to participate in the study would largely bias our results.10. FRI is a relatively rare disease and loss of a few subjects would affect the power of the study.11. During the COVID-19 pandemic period, there were subjects, especially older patients, with severe medical condition and co-infected with SARS-CoV2 virus infection, which was not appropriate to approach families during the course of hospitalization.Not applicable.

: The authors declare no conflict of interest.