Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Quality of Life

Soft Tissue Sarcoma

Sending of 2 questionnaires (SF 36 and TESS)

Quality of life questionnaire

Stéphane SUPIOT, PHD-MD

Surgery and radiation therapy play a major role in the treatment of bone and soft tissue tumors. Osteosarcomas, rhabdomyosarcomas, and Ewing tumors are the most common histologic types. Surgery may require multiple techniques and radiation therapy may be conformational, or more recently IMRT (Intensity Modulated Radiation Therapy). If surgery is possible, lower limb surgery is generally the recommended treatment, even if a poor functional result can be expected.

The literature is very poor regarding the impact of radiotherapy on quality of life and functional results, mainly with the use of prosthetic materials.

Tools such as the Toronto Extremity Salvage Score (TESS) are now available for self-assessment of functional outcomes. The presence of large cohorts such as FCCSS, COHOPER and SALTO facilitates these studies.

The SF-36 is a short 36-question health questionnaire that consists of a generic, consistent, and easy-to-administer set of measures. These measures are based on self-report by patients and are now widely used by organizations managing the care of adult patients.

The TESS Functional Questionnaire is a patient-completed self-questionnaire widely used for motor stimulation in patients with musculoskeletal tumors. This score is based on the definitions of handicap, impairment and handicap as documented by the World Health Organization (WHO). It includes 30 questions assessing overall function and daily activities. The final score varies from 0% to 100%, 100% being the best possible score. So far, several studies have reported the validation of TESS in Portuguese, Danish, Korean, Japanese and since this year in French. Indeed, the TESS questionnaire was validated in French by the study "Transcultural validation of TESS and MSTS questionnaires" promoted by the Nantes University Hospital.

Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

Long-term Evaluation of the Quality of Life and the Functional Repercussions of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

Institut Cancerologie de l'Ouest

Symptoms and General Pathology

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

Depression

Anxiety Disorders

Depressive Disorder

Psychotropic Drugs

All Drugs and Chemicals

Fluoxetine

* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values

Behavioral Activation

Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

Medication Optimization

Michael Avidan, MBBCh, FCASA

Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.

The proposed research is relevant to public health because the prevalence of undertreated depression/anxiety in older adults coupled with the increasing number of surgeries performed in this population are creating a crucial need for the integration of mental health interventions into critical periods, such as the perioperative period. Thus, the proposed research is relevant to the mission of the NIMH to transform the treatment of mental illnesses through clinical research, paving the way for prevention, recovery, and cure.

Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

National Institute of Mental Health (NIMH)

Washington University School of Medicine

Patient Participants

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.

Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants

Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study

Baseline

1 month

3 months

Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy	NCT04644913	Osteosarcoma in...	Quality of life...	18 Years -	Institut Cancerologie de l'Ouest
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli
Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy	NCT04644913	Osteosarcoma in...	Quality of life...	18 Years -	Institut Cancerologie de l'Ouest
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study	NCT05110690	Older Adults Anxiety Depression Cardiac Surgery Orthopedic Surg... Major Surgical ... Major Surgical ...	Behavioral Acti... Medication Opti...	60 Years -	Washington University School of Medicine
Retrospective Case Series of COVID19+ Patients Undergoing Orthopedic Surgery	NCT05881343	Coronavirus Inf... Orthopedic Diso... Bone Fracture Bone Metastases Bone Neoplasm		-	Istituto Ortopedico Rizzoli

Spots Global Cancer Trial Database for orthopedic surgery