Fall InjuryFFFNCT05712252
Fall, Fracture and Frailty
An observational study of Fall Injury and Hip Fractures, run by Region Skane at 1 site in Sweden.
Trial summary
This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Injury, Hip Fractures, Risk Reduction
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 6 Sep 2025
- How long will I take part?
- 1 Year
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals aged 65 years or older who are admitted to Orthopaedic ward at Skåne University Hospital in Malmö, due to a fall or fall-related trauma.
Who may be able to join
- 65 years or older at the time of admission.
- Admitted to Orthopaedic ward at due to fall, with or without a fracture.
Who cannot join
- Severe head trauma or other severe non-orthopaedic trauma.
- Other condition requiring ward at other department (CCU, ICU) >24 hours.
- Moribund individuals with palliative care only.
- Declined to participate
- Fall > 7 days before admission
- Residence outside the region (lack of follow-up)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care
This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.
Read the detailed description
Background: The knowledge of risk factors for falls and fractures amongst older individuals are enormous, still identification of fallers and prevention of falls is not part of Swedish standard of care. Some risk factors are more or less overlooked, such as alcohol consumption, orthostatic reactions, as are increased risks related to common medications such as certain antidepressants, opioids and sedatives. Although functional activity and frailty scores have been suggested to be potential predictors of adverse events, length of hospital stay and mortality, the use of standardized questionnaires has not been implemented in routine care in Sweden. Furthermore, outcomes after fragility fractures, a well known consequence of falls among older individuals, are continuously poor, although palpable improvements have been reached regarding surgical treatment. Are there other factors that are equally or more decisive for the global outcome from the patient's point of view?
Material \& Methods: In this prospective observational cohort study, all in-patients treated due to a fall-related trauma (fracture, dislocation or contusion) at the Department of Orthopaedics, Skane University Hospital Malmö, aged 65 years or older will be invited to participate during a 1-year study period. In all participants, a standard package of blood samples, temperature, measurement of orthostatic blood pressure and grip strength, grading of frailty and activity will be routinely obtained.
- Conditions
- Fall Injury, Hip Fractures, Risk Reduction, Osteoporosis, Osteopenia, Frailty
- Keywords
- Falls, Fracture, Frailty, Orthogeriatric
- Medical subject headings
- Hip Fractures, Risk Reduction Behavior, Osteoporosis, Bone Diseases, Metabolic, Frailty, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fallers without a fracture | Individuals who obtain no fracture. | |
| Fallers with a fracture | Individuals who obtain one or several fractures through fall. This group can be further subgrouped according to type of fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The number of deaths during follow-up
Measured: One year after admission to hospital
Re-admission
Number of re-admissions to emergency centre or in-patient ward due to a new fall (primarily) or complications related previous fall/fracture
Measured: One year after admission to hospital
Other adverse events
Other adverse events that are not included in outcome measure 1 or 2, such as infection, new falls, fractures, or complications from previous fall/fracture, or other medical complications. These can be further grouped by whether the events occur in in-patient or out-patient care.
Measured: One year after admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2023
- Primary completion6 Oct 2024
- Study completion6 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Rogmark, MD, PhD, Principal investigator, Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712252
- Sponsor's protocol ID
- 2022-01997-01
- Acronym
- FFF
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available because of patient integrity but anonymized, supplementary data supporting the findings of individual studies are available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care
- ClinicalTrials.gov ID
- NCT05712252
- Acronym / sponsor ID
- FFF / 2022-01997-01
- Conditions
- Fall Injury, Hip Fractures, Risk Reduction, Osteoporosis, Osteopenia, Frailty
- Keywords
- Falls, Fracture, Frailty, Orthogeriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 6 Sep 2025 (actual)
- First posted
- 3 Feb 2023 (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 project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.
Detailed description
Background: The knowledge of risk factors for falls and fractures amongst older individuals are enormous, still identification of fallers and prevention of falls is not part of Swedish standard of care. Some risk factors are more or less overlooked, such as alcohol consumption, orthostatic reactions, as are increased risks related to common medications such as certain antidepressants, opioids and sedatives. Although functional activity and frailty scores have been suggested to be potential predictors of adverse events, length of hospital stay and mortality, the use of standardized questionnaires has not been implemented in routine care in Sweden. Furthermore, outcomes after fragility fractures, a well known consequence of falls among older individuals, are continuously poor, although palpable improvements have been reached regarding surgical treatment. Are there other factors that are equally or more decisive for the global outcome from the patient's point of view?
Material \& Methods: In this prospective observational cohort study, all in-patients treated due to a fall-related trauma (fracture, dislocation or contusion) at the Department of Orthopaedics, Skane University Hospital Malmö, aged 65 years or older will be invited to participate during a 1-year study period. In all participants, a standard package of blood samples, temperature, measurement of orthostatic blood pressure and grip strength, grading of frailty and activity will be routinely obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallers without a fracture | – | –Individuals who obtain no fracture. |
| Fallers with a fracture | – | –Individuals who obtain one or several fractures through fall. This group can be further subgrouped according to type of fracture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals aged 65 years or older who are admitted to Orthopaedic ward at Skåne University Hospital in Malmö, due to a fall or fall-related trauma.
Key inclusion criteria (2 listed)
- 65 years or older at the time of admission.
- Admitted to Orthopaedic ward at due to fall, with or without a fracture.
Key exclusion criteria (6 listed)
- Severe head trauma or other severe non-orthopaedic trauma.
- Other condition requiring ward at other department (CCU, ICU) >24 hours.
- Moribund individuals with palliative care only.
- Declined to participate
- Fall > 7 days before admission
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
Mortality
Time frame: One year after admission to hospital
The number of deaths during follow-up
Re-admission
Time frame: One year after admission to hospital
Number of re-admissions to emergency centre or in-patient ward due to a new fall (primarily) or complications related previous fall/fracture
Other adverse events
Time frame: One year after admission to hospital
Other adverse events that are not included in outcome measure 1 or 2, such as infection, new falls, fractures, or complications from previous fall/fracture, or other medical complications. These can be further grouped by whether the events occur in in-patient or out-patient care.
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 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available because of patient integrity but anonymized, supplementary data supporting the findings of individual studies are available upon reasonable request to the corresponding author.
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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.
Cecilia Rogmark, MD, PhD principal investigator
Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
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 Fall Injury and Hip Fractures, run by Region Skane 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 6 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 14 Oct 2026. 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: One year after admission to hospital). The study lists 3 primary outcomes in all. 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 Oct 2026.