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Detection of Covid-19 in Tissue Samples of Orthopedic Origin

4. juni 2021 oppdatert av: Centre de l'arthrose, Paris

Detection of Covid-19 in Tissue Samples of Orthopedic Origin: a Prospective Cohort Study

Background The presence of the Covid-19 virus has been detected in tissues of various origins: nasopharyngeal swabs, sputum, bronchoalveolar fluid, blood, stool and anal swabs. However, it does not appear that the virus is excreted in the urine. The REACTing group (Research & Action Emerging Infectious Diseases) has demonstrated the presence of the virus in the conjunctiva and pleural fluid. This detection was made possible by carrying out quantitative, real-time RT-PCR and sequencing of the viral genes, which are currently the benchmark for the diagnosis of COVID-19. However, it is not known at this time whether the Covid-19 virus is present in joint fluid or in bone.

However, some viruses have a particular bone tropism (Parvovirus B19, HHV6); others have joint tropism (parvovirus B19, HBV, HCV, rubella, HIV, HTLV-1). The presence in "orthopedic" tissues of the various coronaviruses (MERS, SARS, etc.) has never been evaluated in the past. However, cases of pulmonary contamination by coronavirus after bone marrow transplantation have been reported in the literature. A potential location at these levels could cause problems of different kinds.

Rationale First, and concretely, a possible direct transmission by these tissues. The current English and Spanish national recommendations in orthopedics show a controversy as to the risk of intraoperative contamination during medical procedures generating aerosols, in particular those involving instruments at high speed (saw blade, reamer, drill). This transmission could also be a problem during bone marrow transplants, from the iliac crests, for example.

Second, but hypothetically, Covid-19 could become quiescent at the level of the myelo-hematopoietic niches and reactivate at a distance, which could then explain the current interrogation on "absence of immunity" and cases of early revival in patients considered cured. This hypothesis is all the more likely since, always by analogy with Parvovirus B19 or HHV6, a recent alert on cases of myocarditis in children has been issued in Parisian pediatric hospitals and that treatment with tocilizumab, which blocks the action Interleukin 6 receptors, and initially used for joint manifestations of rheumatoid arthritis, appear promising.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  • Objective: The objective is to determine if Covid-19 is present in bone and joint tissue from operative parts, extracted during routine procedures, in patients diagnosed with Covid + before the procedure.
  • Methods: Sample form orthopedics procedure that is usually collected will be analysed for the detection of Covid-19
  • Hypothesis: The presence of the virus in the blood suggests a variable amount of presence in the bone tissues, and to a lesser extent articular, of the weakness of their poor vascularity.

Nevertheless, if this is confirmed, understanding of the natural history of the disease would be greatly improved.In the absence of a virus, this would end the controversy about the possibility of contamination by accident from exposure to the block and modify the national recommendations for good orthopedic practices.

Studietype

Observasjonsmessig

Registrering (Faktiske)

15

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Paris, Frankrike, 75011
        • Université de Paris

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

All the patients planned to undergo orthopedic or trauma surgery, and having had a nasopharyngeal sample in their clinical history which was recognized as positive by RT-PCR.

Beskrivelse

Inclusion Criteria:

  • patients eligible for traumatology or orthopedics procedure.
  • > 18 years-old with no upper age limit
  • diagnosed Covid+ using RT-PCR during the past one month

Exclusion Criteria:

  • Pregnant or lactating women or in age to procreate without contraceptive treatment
  • History of mental illness or neurological deficit or adults lacking capacity to consent for themselves
  • Prisoners or young offenders
  • Persons who might not adequately understand verbal explanations or written information given in French, or who have special communication needs
  • Subjects having been or being under an infectious or oncological intercurrent disorder
  • Heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function
  • Any participants who are involved in current research or have recently been involved in any research prior to recruitment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
positive detection rate
Tidsramme: immediately after surgery
rate of patients with possible detection of the virus in an orthopedic sample
immediately after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
viremia
Tidsramme: immediately after surgery
virus detection levels in the blood
immediately after surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Cedric Maillot, MD, APHP

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mai 2020

Primær fullføring (Faktiske)

15. januar 2021

Studiet fullført (Faktiske)

15. mai 2021

Datoer for studieregistrering

Først innsendt

3. juni 2021

Først innsendt som oppfylte QC-kriteriene

4. juni 2021

Først lagt ut (Faktiske)

7. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CovidOS_2020

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Individual participant data will only be done on request and after acceptance of the sponsor's scientific committee if the request is properly justified

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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