Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 14
- 主要终点
- Oxford Elbow Score
研究概览
简要总结
Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.
详细描述
Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Patient instructed not to reveal treatment and to wear long sleeves.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced olecranon fracture (Mayo 2A and 2B).
排除标准
- •Associated fractures in the coronoid process, radial head or distal humerus.
- •Open fracture, Gustilo-Andersen 2 or 3
- •Severe cardiopulmonary disease or other medical condition which contraindicates surgery.
- •Previous injury to or other condition in the elbow with serious functional impairment
结局指标
主要结局
Oxford Elbow Score
时间窗: 52 weeks
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
次要结局
- Range of motion(52 weeks)
- Elbow extension strength(52 weeks)
- Elbow satisfaction(52 weeks)
- Complications(Through study period up to 52 weeks.)
- Number of Reoperations(Through study period up to 52 weeks.)
- Oxford Elbow Score(12 weeks)
研究者
Frede Frihagen
Associate professor
Oslo University Hospital