Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Difference of DASH-score between two study groups
研究概览
简要总结
A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture
详细描述
Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.
Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 50 years-old
- •primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
- •primary reduction of fracture is acceptable considering primary conservative treatment
排除标准
- •bilateral and open fractures and fractures with neurovascular compromise
- •other major concurrent fracture necessitating treatment of any kind
- •patients under 50 years of age
- •previous ipsilateral distal radius fracture
- •inflammatory joint disease
- •significant radiocarpal-joint degeneration
- •patient's bad co-operation or major co-morbidity making an operation contraindicated
结局指标
主要结局
Difference of DASH-score between two study groups
时间窗: 2 year observation
Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
次要结局
- Difference of radiological parameters between two study groups(2 year observation)
