Hip Fracture in Individuals Under 60 Years of Age

NCT ID: NCT03848195

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-29

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Hip Fractures

Keywords

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hip fractures adult middle-aged DXA-scan osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Strøm Rönnquist

MD, orthopaedic surgeon, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cecilia Rogmark, MD, PhD

Role: STUDY_DIRECTOR

Lund University, Skane University Hospital, Department of Orthopaedics, Sweden

Locations

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Department of Orthopaedics, Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Site Status

Department of Orthopaedic Surgery and Traumatology, Kolding Hospital - part of Hospital Lillebaelt

Kolding, , Denmark

Site Status

Department of Orthopaedic Surgery and Traumatology, Odense University Hospital

Odense, , Denmark

Site Status

Skane University Hospital, Department of Orthopaedics

Malmo, , Sweden

Site Status

Countries

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Denmark Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HFU-60

Identifier Type: -

Identifier Source: org_study_id