Clinical trial NCT05712252: Risk Factors for Fall and Fracture
Official title: Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fall Injury
Hip Fractures
Risk Reduction
Osteoporosis, Osteopenia
Frailty
Keywords: Falls
Fracture
Frailty
Orthogeriatric
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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:

* Younger than 65 years old at the time of admission.
* Severe head trauma or other severe non-orthopaedic trauma.
* Other condition requiring ward at other department (CCU, ICU).
* Moribund individuals with palliative care only.

Primary outcomes:
measure: Mortality
timeFrame: One year after admission to hospital
measure: Re-admission
timeFrame: One year after admission to hospital
measure: Other adverse events
timeFrame: One year after admission to hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Orthopaedics
state: Skåne
Study officials:
affiliation: Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
name: Cecilia Rogmark, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: