Hip Fracture in Individuals Under 60 Years of Age (HFU-60)

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures

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 Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Department of Orthopaedics, Copenhagen University Hospital Hvidovre
  • Kolding, Denmark, 6000
    • Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt
  • Odense, Denmark, 5000
    • Department of Orthopaedic Surgery and Traumatology, Odense University Hospital
• Sweden
  • Malmö, Sweden, 20502
    • Skane University Hospital, Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density (BMD) at the time of the fracture	Analysis of BMD measured by DXA-scan at the time of the fracture.	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.	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.	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).	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.	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).	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.	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).	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.	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.	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.	Patients are followed up during two years
Complications after hip fracture surgery	Type and rate of complications after hip fracture surgery (clinical) are recorded.	Patients are followed up during two years
Reoperations after hip fracture surgery	Type and frequency of reoperations after hip fracture surgery (clinical).	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.	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.	Patients are followed up during two years

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: University of Copenhagen; University of Southern Denmark
• Investigators: Study Director: Cecilia Rogmark, MD, PhD, Lund University, Skane University Hospital, Department of Orthopaedics, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: adult; osteoporosis; hip fractures; middle-aged; DXA-scan
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: HFU-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No