Hip Fracture in Individuals Under 60 Years of Age

Hip Fractures Clinical Trial

— HFU-60  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848195
• Other study ID #: HFU-60
• Status: Completed
• Start date: July 29, 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2023
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Denmark	Department of Orthopaedics, Copenhagen University Hospital Hvidovre	Hvidovre
Denmark	Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt	Kolding
Denmark	Department of Orthopaedic Surgery and Traumatology, Odense University Hospital	Odense
Sweden	Skane University Hospital, Department of Orthopaedics	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	University of Copenhagen, University of Southern Denmark

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

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