Hip FractureNCT06773884
Population-based Registry Study on Primary Hip Fracture Surgery
An observational study of Hip Fracture, run by Region Örebro County at 1 site in Sweden.
Trial summary
This study aims to describe primary hip fracture surgeries and to identify patient-related and perioperative risk factors affecting outcomes. It will utilize data from the Swedish Perioperative Registry (SPOR) and the Swedish National Patient Register to track epidemiological changes, treatment outcomes, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- "Observational Analysis of Primary Hip Fracture Surgery Outcomes"
- How many people
- 90,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older who underwent hip fracture surgery and were recorded in SPOR from January 1, 2018, to December 31, 2022.
Who may be able to join
- Patients aged 18+ with hip fractures, identified through ICD code S72*, who underwent surgery during the study period.
Who cannot join
- Patients without a Swedish personal identification number, as this is necessary to link data across registers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to describe primary hip fracture surgeries and to identify patient-related and perioperative risk factors affecting outcomes. It will utilize data from the Swedish Perioperative Registry (SPOR) and the Swedish National Patient Register to track epidemiological changes, treatment outcomes, and perioperative factors.
Read the detailed description
Hip fractures, a significant health concern among the elderly, necessitate hospitalization and surgical intervention, with high mortality and morbidity rates within the first year post-surgery. The study will retrospectively analyze records of approximately 90,000 patients over 18 who underwent hip fracture surgery between 2018 and 2022. Key factors such as age, sex, preoperative health status, and perioperative care methods will be evaluated to determine their impact on complications, reoperation rates, and survival.
This research could inform future clinical practices and policies, aiming to optimize the treatment and management of elderly patients with hip fractures.
- Conditions
- Hip Fracture
- Being tested
- "Observational Analysis of Primary Hip Fracture Surgery Outcomes"
- Keywords
- Hip Fracture, Primary Hip Fracture Surgery, Perioperative Risk Factors, Reoperation Rates, Mortality, Geriatric Fractures, Epidemiology, Swedish Perioperative Registry (SPOR), Population-Based Study
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Observational Analysis of Primary Hip Fracture Surgery Outcomes"Other
This study examines outcomes following standard primary hip fracture surgery by analyzing retrospective data from national health registries. The focus is on identifying perioperative and patient-related risk factors that influence outcomes such as reoperation rates, mortality, and secondary fractures within one year of surgery. No experimental or new intervention is introduced in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reoperation and secondary fractures.
Rate of reoperation and secondary fractures within one year post-surgery.
Measured: One year post-surgery
Secondary outcomes (1)
Mortality rate, hospitalization duration, and time to surgery
Mortality rate, hospitalization duration, and time to surgery
Measured: One year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- 90,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773884
- Sponsor's protocol ID
- EPM 2024-03060-01
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Registry Study on Primary Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT06773884
- Acronym / sponsor ID
- EPM 2024-03060-01
- Conditions
- Hip Fracture
- Keywords
- Hip Fracture, Primary Hip Fracture Surgery, Perioperative Risk Factors, Reoperation Rates, Mortality, Geriatric Fractures, Epidemiology, Swedish Perioperative Registry (SPOR)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
This study aims to describe primary hip fracture surgeries and to identify patient-related and perioperative risk factors affecting outcomes. It will utilize data from the Swedish Perioperative Registry (SPOR) and the Swedish National Patient Register to track epidemiological changes, treatment outcomes, and perioperative factors.
Detailed description
Hip fractures, a significant health concern among the elderly, necessitate hospitalization and surgical intervention, with high mortality and morbidity rates within the first year post-surgery. The study will retrospectively analyze records of approximately 90,000 patients over 18 who underwent hip fracture surgery between 2018 and 2022. Key factors such as age, sex, preoperative health status, and perioperative care methods will be evaluated to determine their impact on complications, reoperation rates, and survival.
This research could inform future clinical practices and policies, aiming to optimize the treatment and management of elderly patients with hip fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who underwent hip fracture surgery and were recorded in SPOR from January 1, 2018, to December 31, 2022.
Key inclusion criteria (1 listed)
- Patients aged 18+ with hip fractures, identified through ICD code S72*, who underwent surgery during the study period.
Key exclusion criteria (1 listed)
- Patients without a Swedish personal identification number, as this is necessary to link data across registers.
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 |
|---|---|---|
| "Observational Analysis of Primary Hip Fracture Surgery Outcomes"This study examines outcomes following standard primary hip fracture surgery by analyzing retrospective data from national health registries. The focus is on identifying perioperative and patient-related risk factors that influence outcomes such as reoperation rates, mortality, and secondary fractures within one year of surgery. No experimental or new intervention is introduced in this study. | Other | – |
Primary outcome
Rate of reoperation and secondary fractures.
Time frame: One year post-surgery
Rate of reoperation and secondary fractures within one year post-surgery.
1 secondary outcome
Mortality rate, hospitalization duration, and time to surgery
Time frame: One year post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- 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.
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 Fracture, run by Region Örebro County 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 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of reoperation and secondary fractures. (time frame: One year post-surgery). 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 14 Jan 2025.