Effectiveness and Cost-effectiveness of Conservative and Operative Treatment of Three- and Four-part Fractures of the Proximal Humerus. A Nested Randomised Controlled Trial and Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Constant Score
研究概览
简要总结
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation.
The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years and older
- •Acute trauma:
- •randomisation (op vs cons) within 7 days of injury.
- •3- or 4-part fracture with >5mm dislocation of the anatomic neck.
- •AO classification C1-2 for non-luxation fractures
- •AO classification C3 for luxation fractures
排除标准
- •Head Splitting fracture
- •Open fracture
- •Additional fractures in the shoulder region
- •Other injuries requiring surgical treatment
- •Clinically significant injury of the brachial plexus or vasculature
- •Pathological fracture associated with cancer
- •History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
- •Rheumatoid Arthritis in the shoulder requiring active treatment
- •Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
- •unwillingness to accept some of the treatment options.
结局指标
主要结局
Constant Score
时间窗: 3 mo, 6 mo, 1 year, 2 years
Pain at rest Numeric Rating Scale 0-10 (NRS)
时间窗: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
Pain in active motion NRS
时间窗: 6 weeks, 3 mo, 6 mo, 1 year, 2 years
次要结局
- Subjective satisfaction(6 weeks, 3 mo, 6 mo, 1 year, 2 years)
- Simple Shoulder Test (SST)(3 mo, 6 mo, 1 year, 2 years)
- Quality of life assessed with 15D(6 weeks, 3 mo, 6 mo, 1 year, 2 years)
- Disabilities of the Arm, Shoulder and Hand (DASH)(3 mo, 6 mo, 1 year, 2 years)
- Complications(6 weeks, 3 mo, 6 mo, 1 year, 2 years)
研究者
Tuomas Lahdeoja
MD
University of Helsinki