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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06462885
Other study ID # HSRZOKZZ3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 30, 2022

Study information

Verified date June 2024
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to assess the effect of living alone on total hip arthroplasty thirty-day outcomes. The main questions it aims to answer are: Is living alone associated with discharge disposition (home versus non-home)? Is living alone associated with greater incidences of secondary adverse events? Participants will be sampled from the 2021 American College of Surgeons National Surgical Quality Improvement Program


Recruitment information / eligibility

Status Completed
Enrollment 5677
Est. completion date January 30, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Elective, non-emergent cases - Living alone - Living with others Exclusion Criteria: - Fracture in surgical diagnosis - Hospital admission >1 day preoperatively - End-stage renal disease (preoperative) - Metastatic disease (preoperative) - Sepsis (preoperative) - Bleeding diathesis (preoperative) - American Society of Anesthesiologists Physical Status Classification 5

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
home support, hiving alone
Home support: living alone
home support, living with others
Home support: living with others

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Discharge disposition Home versus non-home Thirty days
Secondary Requiring home services Thirty days
Secondary Functional status at discharge Dependent versus independent Thirty days
Secondary Postoperative delirium Thirty days
Secondary Hospital length of stay Thirty days
Secondary Unplanned resource utilization Unplanned readmission and return to the operating room Thirty days
Secondary Wound complications Superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, and wound dehiscence Thirty days
Secondary Systemic complications Cardiac arrest, myocardial infarction, stroke, reintubation, pneumonia, deep venous thrombosis, pulmonary embolism, bleeding, sepsis, septic shock, and acute kidney injury Thirty days
Secondary Bleeding events Requiring transfusion Thirty days
Secondary Mortality Thirty days
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