Hip FracturesNCT03749122
Time to Hip Fracture Surgery
An observational study of Hip Fractures and Mortality, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of… Read more about this study
- Who is it for?
- Ages 60 to 105 years
- Conditions the study is for
- Hip Fractures, Mortality, Surgery
- What is being tested?
- Waiting time for hip fracture surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2006to 31 Dec 2016
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute hip fracture
Who may be able to join
- hip fracture surgery between 2007-2016.
- Over 60 years of age.
Who cannot join
- Pathological fracture.
- In-hospital falls.
- Diagnostic delay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Waiting Time to Surgery Related to Mortality in Hip Fracture Patients
The purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status Classification, type of surgery and time from admission to surgery along with data on mortality.
- Conditions
- Hip Fractures, Mortality, Surgery
- Being tested
- Waiting time for hip fracture surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waiting time for hip fracture surgeryProcedure or surgery
Time from hospital admission to start of hip fracture surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Date of Death captured through Swedish Taxation Authority within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Nellgård, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749122
- Sponsor's protocol ID
- 331-16
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2018
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Waiting Time to Surgery Related to Mortality in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT03749122
- Acronym / sponsor ID
- 331-16
- Conditions
- Hip Fractures, Mortality, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Nov 2018 (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 the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status Classification, type of surgery and time from admission to surgery along with data on mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute hip fracture
Key inclusion criteria (2 listed)
- hip fracture surgery between 2007-2016.
- Over 60 years of age.
Key exclusion criteria (3 listed)
- Pathological fracture.
- In-hospital falls.
- Diagnostic delay.
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 |
|---|---|---|
| Waiting time for hip fracture surgeryTime from hospital admission to start of hip fracture surgery | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: 30 days
Date of Death captured through Swedish Taxation Authority within 30 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 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Fractures and Mortality, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 inclusion and 3 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 13 Dec 2023. 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 Sweden. 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?
Mortality (time frame: 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 13 Dec 2023.