ComplicationNCT03375268
Predictive Model for Postoperative Complications in Hemi-hip Arthroplasty
An observational study of Complication and Risk Factor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Complication, Risk Factor, Elderly Patient
- How many people
- 460 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2011to 31 Aug 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2011 to December 2015, we will enroll adult patients aged 60 years or older who underwent Hemi-hip Arthroplasty at our institution.
Who may be able to join
- A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty
Who cannot join
- 1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Eulji university hospital
Seoul, 01830
Eunsu Choi, Pf, 1032990658, potterydoll@hanmail.net
About this study
Official title: Predictive Model for Postoperative Complications in Elderly Patients With Hip Arthroplasty: Retrospective Study
The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.
Read the detailed description
We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.
- Conditions
- Complication, Risk Factor, Elderly Patient, Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
we collect postoperative complications which include cardiac, pulmonary renal, cerebral, and other complications.
Measured: from operation day to postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eunsu Choi, pf, Principal investigator, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375268
- Sponsor's protocol ID
- 2017-10-003
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Model for Postoperative Complications in Elderly Patients With Hip Arthroplasty: Retrospective Study
- ClinicalTrials.gov ID
- NCT03375268
- Acronym / sponsor ID
- 2017-10-003
- Conditions
- Complication, Risk Factor, Elderly Patient, Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 18 Dec 2017 (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 purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.
Detailed description
We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2011 to December 2015, we will enroll adult patients aged 60 years or older who underwent Hemi-hip Arthroplasty at our institution.
Key inclusion criteria (1 listed)
- A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty
Key exclusion criteria (1 listed)
- 1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative complications
Time frame: from operation day to postoperative 30 days
we collect postoperative complications which include cardiac, pulmonary renal, cerebral, and other complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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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.
Eunsu Choi, pf principal investigator
Eulji University Hospital
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 Complication and Risk Factor, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Dec 2017. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunsu Choi, pf (821032990658, potterydoll@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: from operation day to postoperative 30 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 Dec 2017.