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Completed

NCT Number: NCT03848195

Hip Fracture in Individuals Under 60 Years of Age

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.

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Key information

Conditions

Hip Fractures Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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).

  7. 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.

  8. 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).

  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. 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.

  11. 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.

  12. 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.

  13. Reoperations after hip fracture surgery

    Time frame: Patients are followed up during two years

    Type and frequency of reoperations after hip fracture surgery (clinical).

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • University of Copenhagen
  • University of Southern Denmark

Registry information

Official study 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

Acronym: HFU-60

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Dec 12, 2023

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.

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