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Hip Fracture in Individuals Under 60 Years of Age

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03848195
Acronym
HFU-60
Enrollment
218
Registered
2019-02-20
Start date
2015-07-29
Completion date
2020-12-31
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

hip fractures, adult, middle-aged, DXA-scan, osteoporosis

Brief 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.

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.

Interventions

None listed

Sponsors

University of Copenhagen
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Acute non-pathologic hip fracture regardless of trauma energy level or previous medical conditions.

Exclusion criteria

* Fracture older than four weeks. * Not able to follow up, e.g. not living in the department area.

Design outcomes

Primary

MeasureTime frameDescription
VAS-pain, satisfaction, rehabilitation (VAS-psr)Patients are followed up during two yearsAnalysis 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.
Bone Mineral Density (BMD) at the time of the fractureBaselineAnalysis of BMD measured by DXA-scan at the time of the fracture.
Trauma mechanism leading to the hip fractureBaselineAnalysis 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)BaselineAnalysis of the patients' hip fracture types on diagnostic radiographs.
EQ-5DPatients are followed up during two yearsAnalysis 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-VASPatients are followed up during two yearsAnalysis 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 ScorePatients are followed up during two yearsAnalysis 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).
New Mobility ScorePatients are followed up during two yearsAnalysis 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 goPatients are followed up during two yearsAnalysis of outcome with timed up and go test (functional) measured in seconds. Shorter time indicates better outcome.
10 meter walking testPatients are followed up during two yearsAnalysis of outcome with 10 meter walking test (functional) measured in seconds. Shorter time indicates better outcome.
Hand grip strengthPatients are followed up during two yearsAnalysis of outcome with hand grip strength (functional) measured in kg. Higher value indicates better outcome.
Complications after hip fracture surgeryPatients are followed up during two yearsType and rate of complications after hip fracture surgery (clinical) are recorded.
Reoperations after hip fracture surgeryPatients are followed up during two yearsType and frequency of reoperations after hip fracture surgery (clinical).
Radiological outcome after hip fracture surgeryPatients are followed up during two yearsAnalysis of radiological outcome after hip fracture surgery. Radiographs are assessed according to pre-defined criteria.
Diagnosis of avascular necrosis by MRI with metal artefact reductionPatients are followed up during two yearsAnalysis of the use of MRI MARS to assess avascular necrosis of the femoral head in patients with femoral neck fracture treated with internal fixation.

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026