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NCT Number: NCT05881343

Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

Over the last months, the Rizzoli Orthopedic Institute in Bologna, Italy, has drained orthopedic urgencies from all other hospitals in the urban and suburban area. In this context urgencies are defined as fractures and primary or metastatic bone lesions with indication to non-deferrable surgery. A subset of these patients tested positive for SARS CoV 2, either before or after the surgical procedure.

Anesthesiological clinical management of covid19 cases is complicated by the consequences of the viral infection on respiratory and cardio-vascular systems, renal function and coagulation. Similarly, management of asymptomatic patients is challenging because of the lack of data on possible specific complications.

This study will report a snapshot of our early experience on perioperative clinical management of patients undergoing orthopedic surgery in the presence of SARS CoV 2 infection, ascertained or not at the time of surgery.

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Key information

Conditions

Coronavirus Infection Bone Diseases Bone Fracture Bone Metastases Bone Neoplasm Bone Neoplasms COVID-19 Coronaviridae Infections Coronavirus Infections Fractures, Bone Infections Lung Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nidovirales Infections Orthopedic Disorder Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

IORizzoli

Bologna, BO, 40136, Italy

About this study

This is a monocentric, retrospective, observational study.

the study will analyze all medical records of patients that underwent major or non-delayable orthopaedic surgery from the 1st of March 2020 to the 30th of June 2020 with known ongoing Coronavirus infection or postoperative diagnosis via nasal swab test collected at Rizzoli Orthopaedic Institute.

Medical history, anthropometrical, clinical, radiological, and biochemical data will be inserted in a database.

Primary objective will be to estimate population mortality in the time frame from surgery to hospital discharge.

Secondary objectives will be estimation of correlation between SARS-CoV2 infection and main postoperative complications. Mortality and site infection rate will be compared among the cohort and pre-COVID19 similar data.

Continuous variables will be summarized using median and interquartile range while dichotomic variables will be expressed as absolute and relative frequencies. Frequencies and outcomes will be reported as absolute frequency (observed / total) and relative percentage. Association between independent variables and outcomes will be tested with multivariate analysis, hypothesis testing (t-test or Mann-Whitney) and Fisher's exact test according to the type of variable and its distribution (and the experimental question at hand). Variables showing statistically significant association (p<0.1), will be used to build a multivariate logistic regression model with dichotomic dependent variable. Statistical significance threshold will be set to 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients urdergoing non-deferrable Orthopaedical surgery
  • Ascertained SARS-CoV-2 infection detected by nasopharyngeal swab before of after the surgery
  • Written, signed informed consent to the trial.

Exclusion criteria

  • Lack of signed informed consent.

Treatment and study plan

Primary outcomes

  1. SARS-CoV-2 infection

    Time frame: at baseline (day 0)

    Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery

  2. SARS-CoV-2 mortality

    Time frame: at baseline (day 0)

    Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery

Secondary outcomes

  1. Population

    Time frame: at baseline (day 0)

    Descriptive analysis of the characteristics of the population

  2. Known SARS-CoV2 infection and type of anesthesia

    Time frame: at baseline (day 0)

    Correlation between known SARS-CoV2 infection at the time of surgery and type of anesthesia

  3. Known SARS-CoV2 mortality

    Time frame: at baseline (day 0)

    Correlation between known SARS-CoV2 infection at the time of surgery and mortality

  4. Known SARS-CoV2 infection

    Time frame: at baseline (day 0)

    Correlation between known SARS-CoV2 infection at the time of surgery and mortality

  5. SARS-CoV2 infection and DVT/PE

    Time frame: at baseline (day 0)

    Correlation between ascertained SARS-CoV2 infection and deep vein thrombosis/pulmonary embolism

  6. SARS-CoV2 and surgical site infection

    Time frame: at baseline (day 0)

    Correlation between ascertained SARS-CoV2 infection and surgical site infection

  7. SARS-CoV2 and postoperative oxygen therapy

    Time frame: at baseline (day 0)

    Correlation between ascertained SARS-CoV2 infection and need for postoperative oxygen therapy / non-invasive or invasive ventilation

  8. SARS-CoV2 infection and TEG

    Time frame: at baseline (day 0)

    Correlation between ascertained SARS-CoV2 infection and thromboelastography indicies.

  9. Mortality in SARS-CoV2 patients vs historical population

    Time frame: at baseline (day 0)

    Comparison of mortality of patients with SARS-CoV2 infection with historical population data subjected to urgent orthopedic surgery.

  10. Surgical site infection in SARS-CoV2 patients vs historical population

    Time frame: at baseline (day 0)

    Comparison of surgical site infection rate of patients with SARS-CoV2 infection with historical population data subjected to urgent orthopedic surgery.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Retrospective Evaluation of Patients With Coronavirus 19 Infection Undergoing Major Orthopedic Urgent Surgery: a Case Series

Acronym: COVID19&SURG

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 31, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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