Fall, Fracture and Frailty (FFF)

July 13, 2025 updated by: Region Skane

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Skåne
      • Malmö, Skåne, Sweden, 20502
        • Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: One year after admission to hospital
The number of deaths during follow-up
One year after admission to hospital
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
One year after admission to hospital
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.
One year after admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Cecilia Rogmark, MD, PhD, Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

October 6, 2024

Study Completion (Estimated)

September 6, 2027

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 13, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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