Clinical trial NCT03848195: Hip Fracture in Individuals Under 60 Years of Age
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: hip fractures
adult
middle-aged
DXA-scan
osteoporosis
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Southern Denmark
First posted: 2019-02-20
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density (BMD) at the time of the fracture
timeFrame: Baseline
measure: Trauma mechanism leading to the hip fracture
timeFrame: Baseline
measure: Hip fracture type according to Garden classification (femoral neck fractures) and Arbeitsgemeinschaft für Osteosynthesefragen (AO)-classification (other hip fractures)
timeFrame: Baseline
measure: EQ-5D
timeFrame: Patients are followed up during two years
measure: EQ-VAS
timeFrame: Patients are followed up during two years
measure: Oxford Hip Score
timeFrame: Patients are followed up during two years
measure: VAS-pain, satisfaction, rehabilitation (VAS-psr)
timeFrame: Patients are followed up during two years
measure: New Mobility Score
timeFrame: Patients are followed up during two years
measure: Timed up and go
timeFrame: Patients are followed up during two years
measure: 10 meter walking test
timeFrame: Patients are followed up during two years
measure: Hand grip strength
timeFrame: Patients are followed up during two years
measure: Complications after hip fracture surgery
timeFrame: Patients are followed up during two years
measure: Reoperations after hip fracture surgery
timeFrame: Patients are followed up during two years
measure: Radiological outcome after hip fracture surgery
timeFrame: Patients are followed up during two years
measure: Diagnosis of avascular necrosis by MRI with metal artefact reduction
timeFrame: Patients are followed up during two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Orthopaedics, Copenhagen University Hospital Hvidovre
city: Kolding
country: Denmark
facility: Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt
city: Odense
country: Denmark
facility: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital, Department of Orthopaedics
Study officials:
affiliation: Lund University, Skane University Hospital, Department of Orthopaedics, Sweden
name: Cecilia Rogmark, MD, PhD
role: STUDY_DIRECTOR
References: