Clinical trial NCT05881343: Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery
Official title: Retrospective Evaluation of Patients With Coronavirus 19 Infection Undergoing Major Orthopedic Urgent Surgery: a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Orthopedic Disorder
Bone Fracture
Bone Metastases
Bone Neoplasm
Keywords: coronavirus
orthopedic surgery
SARS COV 2
COVID19
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing non-deferrable Orthopaedic surgery (fractures, primary or metastatic bone lesions) in presence of SARS-CoV-2 infection, ascertained at the time of the surgery or detected by nasopharyngeal swab after the surgery.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SARS-CoV-2 infection
timeFrame: at baseline (day 0)
measure: SARS-CoV-2 mortality
timeFrame: at baseline (day 0)
Secondary outcomes:
measure: Population
timeFrame: at baseline (day 0)
measure: Known SARS-CoV2 infection and type of anesthesia
timeFrame: at baseline (day 0)
measure: Known SARS-CoV2 mortality
timeFrame: at baseline (day 0)
measure: Known SARS-CoV2 infection
timeFrame: at baseline (day 0)
measure: SARS-CoV2 infection and DVT/PE
timeFrame: at baseline (day 0)
measure: SARS-CoV2 and surgical site infection
timeFrame: at baseline (day 0)
measure: SARS-CoV2 and postoperative oxygen therapy
timeFrame: at baseline (day 0)
measure: SARS-CoV2 infection and TEG
timeFrame: at baseline (day 0)
measure: Mortality in SARS-CoV2 patients vs historical population
timeFrame: at baseline (day 0)
measure: Surgical site infection in SARS-CoV2 patients vs historical population
timeFrame: at baseline (day 0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IORizzoli
state: BO
Study officials:
affiliation: Post-operative Anaesthesia and Intensive Care and Pain Therapy - IRCCS Rizzoli Orthopaedic Institute
name: Stefano Bonarelli, MD
role: PRINCIPAL_INVESTIGATOR
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