Dorsally Displaced Intraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
研究概览
简要总结
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
详细描述
This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female 50-74 years or male 60-74 years
- •Dorsally displaced intraarticular distal radius fracture
- •Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
- •Low energy trauma
- •Injury <72 hours when diagnosed
- •Patient independent of help for ADL
排除标准
- •Earlier dysfunction in any wrist
- •Other major injuries
- •Rheumatoid arthritis or other systemic joint disease
- •Dementia or severe psychiatric disease
- •Severe medical condition making general anesthesia a major risk
研究组 & 干预措施
external fixation
Operation with external fixation and optional addition of k-wire
干预措施: External fixation (Procedure)
Volar plate
Operation with a Synthes volar two column plate (TCP)
干预措施: Volar plate (Procedure)
结局指标
主要结局
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
时间窗: 12 months
次要结局
- A secondary outcome is the degree of malalignment on the x-ray of the injured wrist.(12 months)
- A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument.(12 months)
研究者
Sari Ponzer
Professor, MD, Senior consultant orthopaedic surgeon
Karolinska Institutet