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Not yet recruitingNCT06700031TOFFEEUpdated Nov 21, 2024

Time on Feet After Hip Fracture Event

An observational study in Hip Fractures (ICD-10 72.01-72.2), sponsored by Region Skane. Not yet recruiting at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Region Skane · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Sex
All
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Study summary

With simple technology investigators can map how long it takes for a patient with a hip fracture to be helped and encouraged to stand and walk in the days following the injury. A small sensor on the thigh can measure advanced data regarding movement patterns. The limited research results available show that patients spend too much time lying down or sitting, which can lead to poorer recovery, complications, and an increased risk of death. The project maps the current situation in orthopedic emergency care as well as in orthopedic geriatric care, which is provided in a modern building with single rooms and private bathrooms. In addition to better understanding the significance of different care models, the project aims to present baseline data that future intervention studies can use as control material. The project will also connect the activity level of the patients during the hospital stay with ongoing rehabilitation studies in community follow-up care.

Read the detailed description

Purpose and Specific Objectives Can better diagnosis and prevention of inactivity after hip fractures improve outcomes for individuals and society? The goal is to measure how much individuals with hip fractures move during their hospital stay, to investigate the link between activity levels and complications such as thromboembolism, infections, and mortality, and to use inertial measurement units (IMU) to provide feedback to patients and healthcare providers.

Outcomes after frailty-related fractures remain poor, despite improved orthopedic surgical treatment. Every year, at least 50,000 people over the age of 65 in Sweden sustain a major fracture. Despite enhanced treatment and care, a fracture in older individuals often leads to permanent reductions in function and quality of life. Hip fractures are also associated with an increased risk of death. In addition to personal consequences, the many fractures have significant effects on healthcare and social elder care. Relatives are also affected. Falls are estimated to cost society over 14 billion kronor annually.

To improve recovery and avoid complications after a fracture, coworkers must think broadly and innovatively in healthcare. Given the rapid changes in lifestyle and socioeconomics, it is questionable whether healthcare providers can apply research findings based on previous generations to today's older adults, for example concerning physical activity.

A hip fracture is surgically treated so that the skeleton can withstand immediate weightbearing. However, patients spend too much time immobilized, according to the limited research available. This inactivity can lead to limited recovery, complications such as infections and thromboembolism, longer hospital stays, and an increased risk of death.

02

Conditions studied

  • Hip Fractures (ICD-10 72.01-72.2)

Keywords

  • hip fracture
  • mobilization
  • rehabilitation
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.

Inclusion criteria

  • Having an acute hip fractures and being admitted to either two wards with orthopedic standard care or to one with orthogeriatric care at Skane University Hospital, Malmö

Exclusion criteria

Exclusion Criteria:

  • Lack of standing ability prior to the fracture, defined as requiring a sling lift for transfer
  • Skin disease that prevent the sensor from being attached (dry, flaky, or sore skin, or sensitivity to adhesive)
  • Additional fractures besides the hip fracture or other injuries that reduce mobility (e.g., head or thoracic injuries)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DeviceInertial measurement unit

    A sensor, an inertial measurement unit (IMU), will be attached to the thigh when the individual is on the postoperative ward and will be worn throughout the hospital stay. The IMU measures 7.9 x 3.2 x 0.8 cm and records body positions, movements, and gait parameters.

06

What researchers measure

Primary outcomes

  1. Minutes in upright position per day

    Sitting, standing or walking as measured by the IMU

    Time frame: During hospital stay, an average of one week

Secondary outcomes

  1. Complications within 30 days

    Mortality and Incidence of infection or venous thromboembolism within 30 days

    Time frame: 30 days from surgery

  2. Association with type of fracture

    Association between total time in upright position with type of fracture (intra- or extracapsular)

    Time frame: During hospital stay, an average of one week

  3. Association with type of surgical method

    Association between total time in upright position with type of surgical method (hemiarthroplasty, total hip arthroplasty, internal fixation)

    Time frame: During hospital stay, an average of one week

  4. Association with duration of surgery

    Association between total time in upright position with duration of surgery (min)

    Time frame: During hospital stay, an average of one week

  5. Association with age

    Association between total time in upright position with age (years)

    Time frame: During hospital stay, an average of one week

  6. Association with sex

    Association between total time in upright position with sex (male/female)

    Time frame: During hospital stay, an average of one week

  7. Association with comorbidities (ASA grade)

    Association between total time in upright position with comorbidities measured by ASA grade (American society of anesthesiologists classification system)

    Time frame: During hospital stay, an average of one week

  8. Association with frailty (CFS)

    Association between total time in upright position with frailty (CFS - Clinical Frailty Score)

    Time frame: During hospital stay, an average of one week

  9. Association with presence of dementia

    Association between total time in upright position with presence of dementia (medical record information on ICD-code for dementia disease)

    Time frame: During hospital stay, an average of one week

07

Study locations

1 site
08

References and documents

Publications

  • Moller U O, Fange A M, J K, D S, F F, Hansson E E. Modern technology against falls - A description of the MoTFall project. Health Informatics J. 2021 Apr-Jun;27(2):14604582211011514. doi: 10.1177/14604582211011514. PubMed 34006139 ↗
  • Howell DF, Malmgren Fange A, Rogmark C, Ekvall Hansson E. Rehabilitation Outcomes Following Hip Fracture of Home-Based Exercise Interventions Using a Wearable Device-A Randomized Controlled Pilot and Feasibility Study. Int J Environ Res Public Health. 2023 Feb 10;20(4):3107. doi: 10.3390/ijerph20043107. PubMed 36833801 ↗

Individual participant data

Plan to share: Undecided — Swedish legislation is rigid on this point and request needs to be handled individually

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06700031
Lead sponsor
Region Skane
Collaborators
Lund University
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Nov 22, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Nov 21, 2024

Study contacts

Cecilia Rogmark, MD, PhD
Contact
cecilia.rogmark@skane.se
+46705984992
Therese Jönsson, PhD
Contact
+460703360721
Cecilia Rogmark, PhD, Professor
principal investigator · Lund University
Eva Ekvall Hansson, PhD, Professor
study chair · Department of Health Sciences, Lund University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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