- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06462885
Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Living alone
1,624 patients undergoing elective total hip arthroplasty who were living alone at the time of admission.
|
Home support: living alone
|
|
Living with others
1,624 patients undergoing elective total hip arthroplasty who were living with others at the time of admission.
|
Home support: living with others
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge disposition
Time Frame: Thirty days
|
Home versus non-home
|
Thirty days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding events
Time Frame: Thirty days
|
Requiring transfusion
|
Thirty days
|
|
Requiring home services
Time Frame: Thirty days
|
Thirty days
|
|
|
Functional status at discharge
Time Frame: Thirty days
|
Dependent versus independent
|
Thirty days
|
|
Postoperative delirium
Time Frame: Thirty days
|
Thirty days
|
|
|
Hospital length of stay
Time Frame: Thirty days
|
Thirty days
|
|
|
Unplanned resource utilization
Time Frame: Thirty days
|
Unplanned readmission and return to the operating room
|
Thirty days
|
|
Wound complications
Time Frame: Thirty days
|
Superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, and wound dehiscence
|
Thirty days
|
|
Systemic complications
Time Frame: Thirty days
|
Cardiac arrest, myocardial infarction, stroke, reintubation, pneumonia, deep venous thrombosis, pulmonary embolism, bleeding, sepsis, septic shock, and acute kidney injury
|
Thirty days
|
|
Mortality
Time Frame: Thirty days
|
Thirty days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhiyi Zuo, MD, PhD, University of Virginia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSRZOKZZ3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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