Risk Factors for Fall and Fracture

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712252
• Other study ID #: 2022-01997-01
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Cecilia Rogmark, MD, PhD
• Phone: +4640336123
• Email: cecilia.rogmark[@]skane.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 31, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Fall Injury
• Fractures, Bone
• Frailty
• Hip Fractures
• Osteoporosis
• Osteoporosis, Osteopenia
• Risk Reduction

Locations

Country	Name	City	State
Sweden	Department of Orthopaedics	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The number of deaths during follow-up	One year after admission to hospital
Primary	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	One year after admission to hospital
Primary	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.	One year after admission to hospital