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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 4
- 主要终点
- EQ-5D
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute non-pathologic hip fracture regardless of trauma energy level or previous medical conditions.
排除标准
- •Fracture older than four weeks.
- •Not able to follow up, e.g. not living in the department area.
结局指标
主要结局
EQ-5D
时间窗: 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
时间窗: Patients are followed up during two years
Type and rate of complications after hip fracture surgery (clinical) are recorded.
Reoperations after hip fracture surgery
时间窗: 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)
时间窗: Baseline
Analysis of the patients' hip fracture types on diagnostic radiographs.
Radiological outcome after hip fracture surgery
时间窗: 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
时间窗: Baseline
Analysis of BMD measured by DXA-scan at the time of the fracture.
Trauma mechanism leading to the hip fracture
时间窗: Baseline
Analysis of trauma mechanism, defined as "low-energy trauma" or "not low-energy trauma", leading to the hip fracture.
Hand grip strength
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Sebastian Strøm Rönnquist
MD, orthopaedic surgeon, PhD-student
Lund University