Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

NCT05881343 | Completed

• 1 other identifier: CORONAVIRUS&SURGERY
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Orthopedic Disorder; Bone Fracture; Bone Metastases; Bone Neoplasm

Keywords

coronavirus; orthopedic surgery; SARS COV 2; COVID19

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 infection

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

  at baseline (day 0)

• SARS-CoV-2 mortality

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

  at baseline (day 0)

Secondary Outcomes (10)

• Population

  at baseline (day 0)

• Known SARS-CoV2 infection and type of anesthesia

  at baseline (day 0)

• Known SARS-CoV2 mortality

  at baseline (day 0)

• Known SARS-CoV2 infection

  at baseline (day 0)

• SARS-CoV2 infection and DVT/PE

  at baseline (day 0)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Lack of signed informed consent.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IORizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (10)

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  PMID: 31978945 BACKGROUND

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  PMID: 32031570 BACKGROUND

• Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

  PMID: 32004427 BACKGROUND

• Silverstein WK, Stroud L, Cleghorn GE, Leis JA. First imported case of 2019 novel coronavirus in Canada, presenting as mild pneumonia. Lancet. 2020 Feb 29;395(10225):734. doi: 10.1016/S0140-6736(20)30370-6. Epub 2020 Feb 13. No abstract available.

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• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

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• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Yu P, Zhu J, Zhang Z, Han Y. A Familial Cluster of Infection Associated With the 2019 Novel Coronavirus Indicating Possible Person-to-Person Transmission During the Incubation Period. J Infect Dis. 2020 May 11;221(11):1757-1761. doi: 10.1093/infdis/jiaa077.

  PMID: 32067043 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.

  PMID: 32083643 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Musculoskeletal Diseases; Fractures, Bone; Bone Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Wounds and Injuries; Neoplasms by Site; Neoplasms; Bone Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stefano Bonarelli, MD

  Post-operative Anaesthesia and Intensive Care and Pain Therapy - IRCCS Rizzoli Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: May 31, 2023
• Study Start: July 18, 2020
• Primary Completion: September 30, 2020
• Study Completion: March 1, 2021
• Last Updated: May 31, 2023

Record last verified: 2021-07

Locations

IT (1)