Neoplasms

Symptoms and General Pathology

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Musculoskeletal Diseases

Neoplasm Metastasis

COVID-19

Fractures, Bone

Communicable Diseases

Coronavirus Infections

Bone Neoplasms

Coronaviridae Infections

Nidovirales Infections

Virus Diseases

RNA Virus Infections

Bone Diseases

Stefano Bonarelli, MD

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.

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.

Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery

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

Publication or posting on trial registers

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

Descriptive analysis of the characteristics of the population

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

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

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

Correlation between ascertained SARS-CoV2 infection and surgical site infection

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

Correlation between ascertained SARS-CoV2 infection and thromboelastography indicies.

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

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

Istituto Ortopedico Rizzoli

Rare Diseases

Cysts

Bone Cysts

Bone Cysts, Aneurysmal

Aneurysmal Bone Cysts

Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst

Aneurysmal bone cysts (ABCs) are benign, locally destructive growing bone tumors, which were first described in 1942 by Jaffé and Lichtenstein (1). They are most often diagnosed in childhood and early adulthood. The literature reports that ABCs comprise 1-6% of all primary benign bone tumors (2). Most cases of ABCs (75-90%) are reported for patients younger than 20 years, with a slightly higher incidence for females (3). Most common localizations are the pelvis, the metaphysis of long bones and the spine, but ABCs can also affect any other localization(2). ABCs that are associated with a preexisting osseous lesion are defined as secondary ABCs. They represent approximately 30% of all ABCs (2). Secondary ABCs can occur, e.g., in cases of a giant cell tumor, chondroblastoma or telangiectatic osteosarcoma

The clinical symptoms of an ABC are usually accidently discovered or may consist of pain and swelling in the affected region and pathological fractures ( complete and incomplete ) can be observed occasionally. In conventional radiography a relatively well-defined osteolytic, expansile lesion with possible blowout of the periosteum and a soap-bubble appearance can be found (4). MRI scanning shows cystic formations with typical fluid-fluid levels due to blood sedimentation (7). Because of the possible rapid growth with local destruction, the literature describes cases of ABCs that mimic malignant bone tumors

Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst

Results will discuss in this study, according to assessment of ABC healing ( complete or not ) , and also following assessment of recurrence rate and incidence of complication.

Al-Azhar University

principal investigator

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Neoplastic Processes

Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA

Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score

CT scans are used to generate a finite element model of patient-specific long bones. The bone model is loaded in stance position. Load based on patient's weight and the mechanical response, including the risk of fracture, is computed.

CTFEA

Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Conventional decision algorithm

Haggai Schermann, MD

Amir Sternheim, MD

Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.

Patients will be randomized to two arms and followed prospectively

Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.

The individual participant data will remain in TLVMC and will not be shared

Number of patients who became unable to ambulate for any reason. Inability to ambulate will be determined by an orthopedic surgeon from anamnesis and physical examination.

Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.

Death within 30 days after prophylactic surgery

Infection, re-operation, mechanical failure within 4 months of follow up

The number of surgeries "avoided" - presented only in the group of Intervention and only in patients without the safety endpoint within 4 months of follow up. Specifically, number of patients without the safety endpoint in whom a physician changed his/her decision to operate based on the CT-based FE analysis.

Agreement between the pathological fracture risk estimated using Mirels' scale and the pathological fracture risk CT-based FE simulation analysis. Risk levels determined by either of the estimates: low, medium, high

Number of patients who did not undergo a prophylactic surgery, in whom the CT-based FE analysis showed a risk above moderate for fractures in future and who developed a fracture during the 4 months of follow-up - calculated in both study groups.

Number of patients who underwent a prophylactic surgery, in whom the CT-based FE analysis showed a mild-moderate risk of a fracture and who devel-oped a complication (as defined in a composite safety endpoint) - calculated in both study groups

To compare proportion of patients undergoing surgery in the treatment group vs the control group.

pathological fracture during 4 months of follow up OR death within 30 days after prophylactic surgery in patients who underwent surgery OR surgical complications within 4 months of follow up: infection, re-operation, mechanical failure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli
Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst	NCT05696834	Orthopedic Diso...	Sclerotherapy W...	1 Year -	Al-Azhar University
Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.	NCT03453905	Bone Neoplasm o... Orthopedic Diso... Bone Metastases Proximal Femora...	CTFEA Conventional de...	18 Years - 120 Years	Tel-Aviv Sourasky Medical Center
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli

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