Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months
研究概览
简要总结
With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.
Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.
In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.
The primary aim of the study is
- To understand the epidemiology and prognostic factors for proximal humerus fractures
- Incidence
- Health service utilization
- clinical and functional outcomes
- To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.
We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective
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
- 21 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years old and above
- •Radiologically confirmed proximal humerus fracture
- •Within 3 weeks of their injury
排除标准
- •Open fracture
- •Mentally incompetent patients
- •Co-morbidities precluding anaesthesia
- •Severe soft tissue compromise
- •Neurovascular compromise
- •Pathological fracture other than osteoporosis
- •Surgery delayed > 3 weeks
结局指标
主要结局
Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months
时间窗: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
A 12-item patient-report questionnaire developed to evaluate the outcome of shoulder surgery, excluding surgery for instability. The OSS contains two subscales, pain and activities of daily living. Each responses is of a 0-4 scoring format with a higher score representing better function. Hence, the highest possible total score is 48 and a higher score represents a better outcome.
QuickDASH scoring - change over 6 weeks, 3, 6, 12 months
时间窗: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
This score is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months
时间窗: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
To evaluate the clinical outcomes over time by comparing the change in constant shoulder score over a period of 1 year. The Constant Shoulder Score is used to assess the level of pain and the patient's ability to carry out normal daily activities. Constant score of the unaffected shoulder was also assessed at baseline to compare the function between the two shoulders.
次要结局
- EQ5D-5L - change over 6 weeks, 3, 6, 12 months(Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months)
- Costing questionnaire(Assessed at 6 weeks, 3 months, 4.5 months, 6 months)
研究者
Bryan Tan
Associate Consultant
Tan Tock Seng Hospital