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Clinical Trials/NCT05712252
NCT05712252
Active, not recruiting
Not Applicable

Risk Factors for Fall and Fracture - A Cohort Study of Fall-related Factors Obtained in Routine Orthopaedic Fracture Care

Region Skane1 site in 1 country1,200 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall Injury
Sponsor
Region Skane
Enrollment
1200
Locations
1
Primary Endpoint
Mortality
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
September 6, 2027
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • 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)

Outcomes

Primary Outcomes

Mortality

Time Frame: One year after admission to hospital

The number of deaths during follow-up

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.

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

Study Sites (1)

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