NCT05712252

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Feb 2023Sep 2027

First Submitted

Initial submission to the registry

January 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2024

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2027

Expected
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

January 11, 2023

Last Update Submit

July 13, 2025

Conditions

Keywords

FallsFractureFrailtyOrthogeriatric

Outcome Measures

Primary Outcomes (3)

  • Mortality

    The number of deaths during follow-up

    One year after admission to hospital

  • 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

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • years or older at the time of admission.
  • Admitted to Orthopaedic ward at due to fall, with or without a fracture.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics

Malmo, Skåne County, 20502, Sweden

Location

MeSH Terms

Conditions

Hip FracturesRisk Reduction BehaviorOsteoporosisBone Diseases, MetabolicFrailtyFractures, Bone

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg InjuriesBehaviorBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cecilia Rogmark, MD, PhD

    Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

February 3, 2023

Study Start

February 1, 2023

Primary Completion

October 6, 2024

Study Completion (Estimated)

September 6, 2027

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations