- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05712252
Fall, Fracture and Frailty (FFF)
Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Skåne
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Malmö, Skåne, Sweden, 20502
- Department of Orthopaedics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years or older at the time of admission.
- Admitted to Orthopaedic ward at due to fall, with or without a fracture.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Fallers without a fracture
Individuals who obtain no fracture.
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Fallers with a fracture
Individuals who obtain one or several fractures through fall.
This group can be further subgrouped according to type of fracture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mortality
Time Frame: One year after admission to hospital
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The number of deaths during follow-up
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One year after admission to hospital
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Re-admission
Time Frame: One year after admission to hospital
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Number of re-admissions to emergency centre or in-patient ward due to a new fall (primarily) or complications related previous fall/fracture
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One year after admission to hospital
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Other adverse events
Time Frame: One year after admission to hospital
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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.
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One year after admission to hospital
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cecilia Rogmark, MD, PhD, Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-01997-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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