Detection of Covid-19 in Tissue Samples of Orthopedic Origin

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Diagnostic test: RT-PCR

Detailed Description

• 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Paris, France, 75011
    • Université de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive detection rate	rate of patients with possible detection of the virus in an orthopedic sample	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
viremia	virus detection levels in the blood	immediately after surgery

Collaborators and Investigators

• Sponsor: Centre de l'arthrose, Paris
• Collaborators: Beaujon Hospital
• Investigators: Principal Investigator: Cedric Maillot, MD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CovidOS_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will only be done on request and after acceptance of the sponsor's scientific committee if the request is properly justified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No