Arthropathy of HipNCT06462885
Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
An observational study of Arthropathy of Hip and Perioperative/Postoperative Complications, run by University of Virginia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Hip, Perioperative/Postoperative Complications
- What is being tested?
- home support, hiving alone and home support, living with others
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,677 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elective total hip arthroplasty patients, ACS-NSQIP 2021
Who may be able to join
- Elective, non-emergent cases
- Living alone
- Living with others
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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
- Being tested
- home support, hiving alone, home support, living with others
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home support, hiving aloneBehavioural
Home support: living alone
home support, living with othersBehavioural
Home support: living with others
| Study group | Role | What they receive |
|---|---|---|
| Living alone | 1,624 patients undergoing elective total hip arthroplasty who were living alone at the time of admission. Receives: Behavioral: home support, hiving alone | |
| Living with others | 1,624 patients undergoing elective total hip arthroplasty who were living with others at the time of admission. Receives: Behavioral: home support, living with others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge disposition
Home versus non-home
Measured: Thirty days
Secondary outcomes (9)
Requiring home services
Measured: Thirty days
Functional status at discharge
Dependent versus independent
Measured: Thirty days
Postoperative delirium
Measured: Thirty days
Hospital length of stay
Measured: Thirty days
Unplanned resource utilization
Unplanned readmission and return to the operating room
Measured: Thirty days
Wound complications
Superficial surgical site infection (SSI), deep incisional SSI, organ space SSI, and wound dehiscence
Measured: Thirty days
Systemic complications
Cardiac arrest, myocardial infarction, stroke, reintubation, pneumonia, deep venous thrombosis, pulmonary embolism, bleeding, sepsis, septic shock, and acute kidney injury
Measured: Thirty days
Bleeding events
Requiring transfusion
Measured: Thirty days
Mortality
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HipStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,677 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyi Zuo, MD, University of Virginia
- Investigators
- Zhiyi Zuo, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462885
- Sponsor's protocol ID
- HSRZOKZZ3
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
- ClinicalTrials.gov ID
- NCT06462885
- Acronym / sponsor ID
- HSRZOKZZ3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,677 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living alone | – | Behavioral: home support, hiving alone1,624 patients undergoing elective total hip arthroplasty who were living alone at the time of admission. |
| Living with others | – | Behavioral: home support, living with others1,624 patients undergoing elective total hip arthroplasty who were living with others at the time of admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elective total hip arthroplasty patients, ACS-NSQIP 2021
Key inclusion criteria (3 listed)
- Elective, non-emergent cases
- Living alone
- Living with others
Key exclusion criteria (7 listed)
- Fracture in surgical diagnosis
- Hospital admission >1 day preoperatively
- End-stage renal disease (preoperative)
- Metastatic disease (preoperative)
- Sepsis (preoperative)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home support, hiving aloneHome support: living alone | Behavioural | Living alone |
| home support, living with othersHome support: living with others | Behavioural | Living with others |
Primary outcome
Discharge disposition
Time frame: Thirty days
Home versus non-home
9 secondary outcomes
Requiring home services
Time frame: Thirty days
Functional status at discharge
Time frame: Thirty days
Postoperative delirium
Time frame: Thirty days
Hospital length of stay
Time frame: Thirty days
Unplanned resource utilization
Time frame: Thirty days
Wound complications
Time frame: Thirty days
Systemic complications
Time frame: Thirty days
Bleeding events
Time frame: Thirty days
Mortality
Time frame: Thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Yes. American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyi Zuo, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Hip and Perioperative/Postoperative Complications, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge disposition (time frame: Thirty days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.