Hip Fracture in Individuals Under 60 Years of Age

Completed

• Conditions: Hip Fractures

• Registration Number: NCT03848195
• Lead Sponsor: Lund University

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.

Study Timeline

• Study Start: 2015-07-29
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-10
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EQ-5D	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).
Complications after hip fracture surgery	Patients are followed up during two years	Type and rate of complications after hip fracture surgery (clinical) are recorded.
Reoperations after hip fracture surgery	Patients are followed up during two years	Type and frequency of reoperations after hip fracture surgery (clinical).
Hip fracture type according to Garden classification (femoral neck fractures) and Arbeitsgemeinschaft für Osteosynthesefragen (AO)-classification (other hip fractures)	Baseline	Analysis of the patients' hip fracture types on diagnostic radiographs.
Radiological outcome after hip fracture surgery	Patients are followed up during two years	Analysis of radiological outcome after hip fracture surgery. Radiographs are assessed according to pre-defined criteria.
Bone Mineral Density (BMD) at the time of the fracture	Baseline	Analysis of BMD measured by DXA-scan at the time of the fracture.
Trauma mechanism leading to the hip fracture	Baseline	Analysis of trauma mechanism, defined as "low-energy trauma" or "not low-energy trauma", leading to the hip fracture.
Hand grip strength	Patients are followed up during two years	Analysis of outcome with hand grip strength (functional) measured in kg. Higher value indicates better outcome.
Diagnosis of avascular necrosis by MRI with metal artefact reduction	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.
EQ-VAS	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.
VAS-pain, satisfaction, rehabilitation (VAS-psr)	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.
New Mobility Score	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).
Timed up and go	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 meter walking test	Patients are followed up during two years	Analysis of outcome with 10 meter walking test (functional) measured in seconds. Shorter time indicates better outcome.
Oxford Hip Score	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).

Trial Locations

Locations (4)

Skane University Hospital, Department of Orthopaedics; 🇸🇪 Malmö, Sweden

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, Denmark