Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures: a Prospective Double-center Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Radiographic Non-Union assessed by 2-plane radiograph at 26 weeks post-injury
研究概览
简要总结
Clavicle fractures are common and usually heal well without surgery. Most patients recover full shoulder function within a few weeks with conservative treatment, which is the standard in Denmark. However, in cases where the broken ends of the bone do not touch (displaced fractures), there is a higher risk of complications like non-healing (non-union), affecting 11-18% of such cases. Non-union can lead to long-term pain, reduced shoulder function, and a longer recovery time, often requiring multiple follow-up visits.
While surgery might prevent these complications for some patients, operating on all displaced fractures would lead to overtreatment. The current challenge is identifying which patients are at risk for non-union and would benefit most from surgery. This study aims to investigate the risk factors for non-union in patients with displaced clavicle fractures by examining both patient characteristics and fracture-related factors.
The goal is to use multiple data points to develop a score that can support clinicians and patients in shared decision-making regarding the optimal and individualized treatment for clavicle fractures.
This research is important not only for clavicle fractures but also for understanding and treating non-union in other bones like the ulna and tibia, which face similar challenges.
详细描述
Clavicle fracture The clavicle, the collarbone, connects the arm to the axial skeleton. It is essential to shoulder function as it provides attachment for the primary muscles stabilizing the shoulder joint, and allows an extensive range of motion by the upper limb.
The clavicle fracture is a common skeletal injury that accounts for approximately 5% of all adult fractures and 35-40% of injuries to the shoulder girdle. According to extensive epidemiological studies, the majority of clavicle fractures occur in the middle third, with 50-70% of those being displaced. It means that for every 100 clavicle fractures, approximately half of them are displaced midshaft fractures.
A clavicle fracture is frequently caused by a direct impact to the shoulder, often resulting from same-level falls, bicycle accidents, or sports-related incidents, which makes it a common fracture in Denmark. There is a classic bimodal distribution of the fracture with increased incidence in younger males, usually due to high-energy trauma, and a second peak in the elderly population often associated with low-energy falls. According to the Danish Health Data Authority, the incidence of clavicle fractures is relatively high, approximately 65/100,000 from 1996-2018, and numbers have been increasing throughout the years.
Most clavicle fractures heal uneventfully and are traditionally treated non-operatively with immobilization in an arm sling for a few weeks, typically attaining full recovery and range of motion within six weeks.
Clavicle non-union Fracture non-union is a rare but severe complication that affects 5-10% of all fractures worldwide, depending on fracture location and country. The risk of non-union is higher when the fracture is displaced and bone ends shift out of their normal alignment, especially in the clavicle, which has one of the highest rates of non-union. Non-union can cause long-term pain, physical disability, reduced quality of life, and an extended recovery period before returning to regular work productivity. Often a non-union requires later complex operative treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age upon study enrollment
- •Admitted to the emergency room (ER) at BBH or HVH with a displaced midshaft clavicle fracture
- •Danish social security number
- •Understand Danish
- •Able to fill out questionnaire by hand or online.
- •Provides informed consent prior to initiation of any study-related activities/procedures
排除标准
- •Subject incapable of understanding the patient information or unable to provide informed consent
- •Open fracture or fracture with risk of skin penetration
- •Pathological fracture
- •Clavicle fracture due to polytrauma
- •Floating shoulder injury
- •Vascular injury at fracture site
- •Pregnancy
结局指标
主要结局
Radiographic Non-Union assessed by 2-plane radiograph at 26 weeks post-injury
时间窗: 26 weeks
Measure: Radiographic assessment of non-union using standard 2-plane radiographs at 26 weeks post-injury. Non-Union Assessment: Non-union will be defined as the absence of bridging callus on radiographs at 6 months post-injury, measured on standard 2-plane radiographs of the clavicle. The assessment will include measurement of displacement and shortening (measured in millimeters).
次要结局
- Visual Analog Scale (VAS) score(Week 1 to week 6)
- Shoulder function measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) score(1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Quality of Life measured by the EuroQol (EQ-5D-5L) questionnaire(1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeks.)
- Radiographic assessment of fracture characteristics(1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Plasma concentration of health-related biomarkers(1 week)
- Patient-related factors extracted from medical record(Week 1)
研究者
Ida Tryggedsson
Medical doctor, principal investigator
Bispebjerg Hospital