Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06700031

Time on Feet After Hip Fracture Event

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hip Fractures (ICD-10 72.01-72.2) Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Inertial measurement unit

Device

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.

Primary outcomes

  1. Minutes in upright position per day

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

    Sitting, standing or walking as measured by the IMU

Secondary outcomes

  1. Complications within 30 days

    Time frame: 30 days from surgery

    Mortality and Incidence of infection or venous thromboembolism within 30 days

  2. Association with type of fracture

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

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

  3. Association with type of surgical method

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

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

  4. Association with duration of surgery

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

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

  5. Association with age

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

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

  6. Association with sex

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

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

  7. Association with comorbidities (ASA grade)

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

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

  8. Association with frailty (CFS)

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

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

  9. Association with presence of dementia

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Rogmark, MD, PhD

CONTACT

[email protected]

+46705984992

Therese Jönsson, PhD

CONTACT

+460703360721

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Time on Feet After Hip Fracture Event - the TOFFEE Study

Acronym: TOFFEE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.