Fall, Fracture and Frailty

NCT ID: NCT05712252

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2027-09-06

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.

Conditions

Fall Injury; Hip Fractures; Risk Reduction; Osteoporosis, Osteopenia; Frailty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fallers without a fracture

Individuals who obtain no fracture.

No interventions assigned to this group

Fallers with a fracture

Individuals who obtain one or several fractures through fall. This group can be further subgrouped according to type of fracture.

No interventions assigned to this group

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Rogmark, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden

Locations

Department of Orthopaedics

Malmo, Skåne County, Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-01997-01

Identifier Type: -

Identifier Source: org_study_id