Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

Completed

• Conditions: Coronavirus Infection; Orthopedic Disorder; Bone Metastases; Bone Neoplasm; Bone Fracture

• Registration Number: NCT05881343
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2020-07-18
• Primary Completion: 2020-09-30
• Study Completion: 2021-03-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 mortality	at baseline (day 0)	Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery
SARS-CoV-2 infection	at baseline (day 0)	Overall mortality in patients with ascertained SARS-CoV-2 infection undergoing major orthopaedic surgery

Secondary Outcome Measures

Name	Time	Method
Known SARS-CoV2 infection	at baseline (day 0)	Correlation between known SARS-CoV2 infection at the time of surgery and mortality
SARS-CoV2 infection and DVT/PE	at baseline (day 0)	Correlation between ascertained SARS-CoV2 infection and deep vein thrombosis/pulmonary embolism
SARS-CoV2 infection and TEG	at baseline (day 0)	Correlation between ascertained SARS-CoV2 infection and thromboelastography indicies.
Surgical site infection in SARS-CoV2 patients vs historical population	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.
Known SARS-CoV2 infection and type of anesthesia	at baseline (day 0)	Correlation between known SARS-CoV2 infection at the time of surgery and type of anesthesia
Mortality in SARS-CoV2 patients vs historical population	at baseline (day 0)	Comparison of mortality of patients with SARS-CoV2 infection with historical population data subjected to urgent orthopedic surgery.
Population	at baseline (day 0)	Descriptive analysis of the characteristics of the population
SARS-CoV2 and surgical site infection	at baseline (day 0)	Correlation between ascertained SARS-CoV2 infection and surgical site infection
Known SARS-CoV2 mortality	at baseline (day 0)	Correlation between known SARS-CoV2 infection at the time of surgery and mortality
SARS-CoV2 and postoperative oxygen therapy	at baseline (day 0)	Correlation between ascertained SARS-CoV2 infection and need for postoperative oxygen therapy / non-invasive or invasive ventilation

Trial Locations

Locations (1)

IORizzoli; 🇮🇹 Bologna, BO, Italy