Hip FracturesHFU-60NCT03848195
Hip Fracture in Individuals Under 60 Years of Age
An observational study of Hip Fractures, run by Lund University at 4 sites in 2 countries.
Trial summary
This study prospectively analyses and describes a cohort of non-elderly hip fracture patients at four orthopaedic departments in two Scandinavian countries regarding epidemiology, treatment, Patient Reported Outcome Measures, functional outcome as well as clinical results. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Hip Fractures
- How many people
- 218 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 29 Jul 2015to Dec 2020
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Among hip fracture patients treated at the participating departments, patients aged 18 to 59 years, who sustain an acute non-pathological hip fracture and are treated within four weeks, are invited to participate in the study. All patients are invited, regardless of medical, cognitive and functional pre-fracture status. The participating orthopaedic departments are part of local hospitals, treating all patients in the catchment area who seeks medical care at low (Sweden) or no cost (Denmark).
Who may be able to join
- Acute non-pathologic hip fracture regardless of trauma energy level or previous medical conditions.
Who cannot join
- Fracture older than four weeks.
- Not able to follow up, e.g. not living in the department area.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark3 sites
Department of Orthopaedics, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt
Kolding, 6000
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital
Odense, 5000
Sweden1 site
Skane University Hospital, Department of Orthopaedics
Malmö, 20502
About this study
Official title: Hip Fracture in Individuals Under 60 Years of Age: A Prospective Multi-center Study of the Epidemiology, Treatment, Outcome and Patient Satisfaction Regarding Hip Fractures
This study prospectively analyses and describes a cohort of non-elderly hip fracture patients at four orthopaedic departments in two Scandinavian countries regarding epidemiology, treatment, Patient Reported Outcome Measures, functional outcome as well as clinical results.
Read the detailed description
Hip fracture is common and well studied in the elderly population, but quite rare in the non-elderly and scarcely investigated in the literature. This prospective observational study focuses on individuals between 18 and 59 years old who have incurred a hip fracture and been treated at any of the participating orthopaedic departments in Sweden or Denmark. The study group is analysed and described at the time of the fracture and are followed during two years.
The patients' treatment follows the departments' standard rationale, there is no intervention in the study. Patients are included, after being informed and consent to participate is given, at the ward when they are admitted at the time of the fracture. The study comprises written enquiries (Patient Reported Outcome Measures, PROM) regarding hip- and global health before the fracture as well as interview and medical files and x-ray information regarding previous illness and use of medication, information about the injury, fracture type and treatment. Blood samples are used to investigate possible comorbidities and evaluate the hormonal and nutritional status and dual energy x-ray absorptiometry (DXA) is analysed with regards to reduced bone mineral density (osteopenia/-porosis). For patients with a femoral neck fracture who are treated with osteosynthesis, MRI with metal reduction is performed post-operatively and at 4 and 12 months to assess fracture healing and avascular necrosis of the femoral head.
Patients are followed up at 6 weeks by written PROM-enquiries by mail, and at 4, 12 and 24 months post-operatively with x-ray and visits in the outpatient clinic.
- Conditions
- Hip Fractures
- Keywords
- hip fractures, adult, middle-aged, DXA-scan, osteoporosis
- Medical subject headings
- Hip Fractures, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD) at the time of the fracture
Analysis of BMD measured by DXA-scan at the time of the fracture.
Measured: Baseline
Trauma mechanism leading to the hip fracture
Analysis of trauma mechanism, defined as "low-energy trauma" or "not low-energy trauma", leading to the hip fracture.
Measured: Baseline
Hip fracture type according to Garden classification (femoral neck fractures) and Arbeitsgemeinschaft für Osteosynthesefragen (AO)-classification (other hip fractures)
Analysis of the patients' hip fracture types on diagnostic radiographs.
Measured: Baseline
EQ-5D
Analysis of outcome with EQ5D (PROM). A 5 dimensions, 3-levels, questionnaire regarding general health. A subscore of 1-3 for each dimension combines into a 5 digit code where lower value for each dimension indicate better outcome (total range 11111-33333).
Measured: Patients are followed up during two years
EQ-VAS
Analysis of outcome with EQ-VAS (PROM). A visual analog scale regarding general health ranging from 0-100 where lower value indicate worse outcome.
Measured: Patients are followed up during two years
Oxford Hip Score
Analysis of outcome with Oxford Hip Score (PROM). A 12-item, 5-levels, questionnaire on hip problems in activities of daily living. The subscores 0-4 is added to a total score for the 12 items where a higher score indicate a better outcome (total range 0-48).
Measured: Patients are followed up during two years
VAS-pain, satisfaction, rehabilitation (VAS-psr)
Analysis of outcome with VAS-psr (PROM). Three visual analog scales (one for each dimension) regarding pain, satisfaction and rehabilitation ranging from 0-100 where lower value indicate better outcome.
Measured: Patients are followed up during two years
New Mobility Score
Analysis of outcome with New Mobility Score (PROM). A 3-items questionnaire regarding walking ability. Each item is scored 1-3 and added into a total score where higher score indicate better outcome (total range 3-9).
Measured: Patients are followed up during two years
Timed up and go
Analysis of outcome with timed up and go test (functional) measured in seconds. Shorter time indicates better outcome.
Measured: Patients are followed up during two years
10 meter walking test
Analysis of outcome with 10 meter walking test (functional) measured in seconds. Shorter time indicates better outcome.
Measured: Patients are followed up during two years
Hand grip strength
Analysis of outcome with hand grip strength (functional) measured in kg. Higher value indicates better outcome.
Measured: Patients are followed up during two years
Complications after hip fracture surgery
Type and rate of complications after hip fracture surgery (clinical) are recorded.
Measured: Patients are followed up during two years
Reoperations after hip fracture surgery
Type and frequency of reoperations after hip fracture surgery (clinical).
Measured: Patients are followed up during two years
Radiological outcome after hip fracture surgery
Analysis of radiological outcome after hip fracture surgery. Radiographs are assessed according to pre-defined criteria.
Measured: Patients are followed up during two years
Diagnosis of avascular necrosis by MRI with metal artefact reduction
Analysis of the use of MRI MARS to assess avascular necrosis of the femoral head in patients with femoral neck fracture treated with internal fixation.
Measured: Patients are followed up during two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start29 Jul 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Responsible party
- Principal investigator, Sebastian Strøm Rönnquist, Lund University
- Investigators
- Cecilia Rogmark, MD, PhD, Study director, Lund University, Skane University Hospital, Department of Orthopaedics, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848195
- Sponsor's protocol ID
- HFU-60
- Acronym
- HFU-60
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture in Individuals Under 60 Years of Age: A Prospective Multi-center Study of the Epidemiology, Treatment, Outcome and Patient Satisfaction Regarding Hip Fractures
- ClinicalTrials.gov ID
- NCT03848195
- Acronym / sponsor ID
- HFU-60 / HFU-60
- Conditions
- Hip Fractures
- Keywords
- hip fractures, adult, middle-aged, DXA-scan, osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Study start
- 29 Jul 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Feb 2019 (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.
This study prospectively analyses and describes a cohort of non-elderly hip fracture patients at four orthopaedic departments in two Scandinavian countries regarding epidemiology, treatment, Patient Reported Outcome Measures, functional outcome as well as clinical results.
Detailed description
Hip fracture is common and well studied in the elderly population, but quite rare in the non-elderly and scarcely investigated in the literature. This prospective observational study focuses on individuals between 18 and 59 years old who have incurred a hip fracture and been treated at any of the participating orthopaedic departments in Sweden or Denmark. The study group is analysed and described at the time of the fracture and are followed during two years.
The patients' treatment follows the departments' standard rationale, there is no intervention in the study. Patients are included, after being informed and consent to participate is given, at the ward when they are admitted at the time of the fracture. The study comprises written enquiries (Patient Reported Outcome Measures, PROM) regarding hip- and global health before the fracture as well as interview and medical files and x-ray information regarding previous illness and use of medication, information about the injury, fracture type and treatment. Blood samples are used to investigate possible comorbidities and evaluate the hormonal and nutritional status and dual energy x-ray absorptiometry (DXA) is analysed with regards to reduced bone mineral density (osteopenia/-porosis). For patients with a femoral neck fracture who are treated with osteosynthesis, MRI with metal reduction is performed post-operatively and at 4 and 12 months to assess fracture healing and avascular necrosis of the femoral head.
Patients are followed up at 6 weeks by written PROM-enquiries by mail, and at 4, 12 and 24 months post-operatively with x-ray and visits in the outpatient clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Among hip fracture patients treated at the participating departments, patients aged 18 to 59 years, who sustain an acute non-pathological hip fracture and are treated within four weeks, are invited to participate in the study. All patients are invited, regardless of medical, cognitive and functional pre-fracture status. The participating orthopaedic departments are part of local hospitals, treating all patients in the catchment area who seeks medical care at low (Sweden) or no cost (Denmark).
Key inclusion criteria (1 listed)
- Acute non-pathologic hip fracture regardless of trauma energy level or previous medical conditions.
Key exclusion criteria (2 listed)
- Fracture older than four weeks.
- Not able to follow up, e.g. not living in the department area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density (BMD) at the time of the fracture
Time frame: Baseline
Analysis of BMD measured by DXA-scan at the time of the fracture.
Trauma mechanism leading to the hip fracture
Time frame: Baseline
Analysis of trauma mechanism, defined as "low-energy trauma" or "not low-energy trauma", leading to the hip fracture.
Hip fracture type according to Garden classification (femoral neck fractures) and Arbeitsgemeinschaft für Osteosynthesefragen (AO)-classification (other hip fractures)
Time frame: Baseline
Analysis of the patients' hip fracture types on diagnostic radiographs.
EQ-5D
Time frame: Patients are followed up during two years
Analysis of outcome with EQ5D (PROM). A 5 dimensions, 3-levels, questionnaire regarding general health. A subscore of 1-3 for each dimension combines into a 5 digit code where lower value for each dimension indicate better outcome (total range 11111-33333).
EQ-VAS
Time frame: Patients are followed up during two years
Analysis of outcome with EQ-VAS (PROM). A visual analog scale regarding general health ranging from 0-100 where lower value indicate worse outcome.
Oxford Hip Score
Time frame: Patients are followed up during two years
Analysis of outcome with Oxford Hip Score (PROM). A 12-item, 5-levels, questionnaire on hip problems in activities of daily living. The subscores 0-4 is added to a total score for the 12 items where a higher score indicate a better outcome (total range 0-48).
VAS-pain, satisfaction, rehabilitation (VAS-psr)
Time frame: Patients are followed up during two years
Analysis of outcome with VAS-psr (PROM). Three visual analog scales (one for each dimension) regarding pain, satisfaction and rehabilitation ranging from 0-100 where lower value indicate better outcome.
New Mobility Score
Time frame: Patients are followed up during two years
Analysis of outcome with New Mobility Score (PROM). A 3-items questionnaire regarding walking ability. Each item is scored 1-3 and added into a total score where higher score indicate better outcome (total range 3-9).
Timed up and go
Time frame: Patients are followed up during two years
Analysis of outcome with timed up and go test (functional) measured in seconds. Shorter time indicates better outcome.
10 meter walking test
Time frame: Patients are followed up during two years
Analysis of outcome with 10 meter walking test (functional) measured in seconds. Shorter time indicates better outcome.
Hand grip strength
Time frame: Patients are followed up during two years
Analysis of outcome with hand grip strength (functional) measured in kg. Higher value indicates better outcome.
Complications after hip fracture surgery
Time frame: Patients are followed up during two years
Type and rate of complications after hip fracture surgery (clinical) are recorded.
Reoperations after hip fracture surgery
Time frame: Patients are followed up during two years
Type and frequency of reoperations after hip fracture surgery (clinical).
Radiological outcome after hip fracture surgery
Time frame: Patients are followed up during two years
Analysis of radiological outcome after hip fracture surgery. Radiographs are assessed according to pre-defined criteria.
Diagnosis of avascular necrosis by MRI with metal artefact reduction
Time frame: Patients are followed up during two years
Analysis of the use of MRI MARS to assess avascular necrosis of the femoral head in patients with femoral neck fracture treated with internal fixation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Cecilia Rogmark, MD, PhD study director
Lund University, Skane University Hospital, Department of Orthopaedics, Sweden
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Lund University at 4 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) at the time of the fracture (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.