Hip Fractures (ICD-10 72.01-72.2)TOFFEENCT06700031
Time on Feet After Hip Fracture Event
An observational study of Hip Fractures (ICD-10 72.01-72.2), run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2)
- What is being tested?
- Inertial measurement unit
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 22 Nov 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Therese Jönsson, PhD contact
Sweden1 site
Dept. of Orthopaedics, Skane University Hospital
Malmö, 20502
Malin Lindahl, PT, +4640331000, malin.lindahl@skane.se
Therese Jönsson, PT, PhD, +4646171000, therese.jonsson@med.lu.se
About this study
Official title: Time on Feet After Hip Fracture Event - the TOFFEE Study
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.
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Being tested
- Inertial measurement unit
- Keywords
- hip fracture, mobilization, rehabilitation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial measurement unitDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes in upright position per day
Sitting, standing or walking as measured by the IMU
Measured: During hospital stay, an average of one week
Secondary outcomes (9)
Complications within 30 days
Mortality and Incidence of infection or venous thromboembolism within 30 days
Measured: 30 days from surgery
Association with type of fracture
Association between total time in upright position with type of fracture (intra- or extracapsular)
Measured: During hospital stay, an average of one week
Association with type of surgical method
Association between total time in upright position with type of surgical method (hemiarthroplasty, total hip arthroplasty, internal fixation)
Measured: During hospital stay, an average of one week
Association with duration of surgery
Association between total time in upright position with duration of surgery (min)
Measured: During hospital stay, an average of one week
Association with age
Association between total time in upright position with age (years)
Measured: During hospital stay, an average of one week
Association with sex
Association between total time in upright position with sex (male/female)
Measured: During hospital stay, an average of one week
Association with comorbidities (ASA grade)
Association between total time in upright position with comorbidities measured by ASA grade (American society of anesthesiologists classification system)
Measured: During hospital stay, an average of one week
Association with frailty (CFS)
Association between total time in upright position with frailty (CFS - Clinical Frailty Score)
Measured: During hospital stay, an average of one week
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)
Measured: During hospital stay, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start22 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Cecilia Rogmark, PhD, Professor, Principal investigator, Lund UniversityEva Ekvall Hansson, PhD, Professor, Study chair, Department of Health Sciences, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700031
- Sponsor's protocol ID
- 2023-07759-01
- Other IDs
- 2023
- Acronym
- TOFFEE
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Swedish legislation is rigid on this point and request needs to be handled individually
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 34006139Howell 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time on Feet After Hip Fracture Event - the TOFFEE Study
- ClinicalTrials.gov ID
- NCT06700031
- Acronym / sponsor ID
- TOFFEE / 2023-07759-01
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Keywords
- hip fracture, mobilization, rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 22 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with acute hip fractures regardless of age or cognitive status. The fracture should need surgical treatment.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inertial measurement unitA 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. | Device | – |
Primary outcome
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
9 secondary outcomes
Complications within 30 days
Time frame: 30 days from surgery
Association with type of fracture
Time frame: During hospital stay, an average of one week
Association with type of surgical method
Time frame: During hospital stay, an average of one week
Association with duration of surgery
Time frame: During hospital stay, an average of one week
Association with age
Time frame: During hospital stay, an average of one week
Association with sex
Time frame: During hospital stay, an average of one week
Association with comorbidities (ASA grade)
Time frame: During hospital stay, an average of one week
Association with frailty (CFS)
Time frame: During hospital stay, an average of one week
Association with presence of dementia
Time frame: During hospital stay, an average of one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Results publication: PubMed 34006139Moller 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.
- Results publication: PubMed 36833801Howell 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.
- Individual participant dataSharing planned: Undecided. Swedish legislation is rigid on this point and request needs to be handled individually
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Jönsson, PhD contact
Cecilia Rogmark, PhD, Professor principal investigator
Lund University
Eva Ekvall Hansson, PhD, Professor study chair
Department of Health Sciences, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures (ICD-10 72.01-72.2), run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Rogmark, MD, PhD (+46705984992, cecilia.rogmark@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes in upright position per day (time frame: During hospital stay, an average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.