A Prospective Randomised Trial of Plate Fixation Versus Tension Band Wire for Olecranon Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- DASH
研究概览
简要总结
Proximal forearm fractures comprise approximately 5% of all fractures, with olecranon fractures accounting for almost 20% of thes fractures. There is limited conclusive evidence regarding the optimal treatment and outcome of these fractures with only one prospective randomized trial (1992) in the literature comparing tension band wire and plate fixation for displaced olecranon fracture. Our trial includes all patients under the age of 75yrs presenting to the Edinburgh Orthopaedic Trauma Unit with an isolated olecranon fracture requiring operative intervention. Patients who consent to enrol in the trial will be randomised to operative fixation using one of two recognised fixation techniques - tension band wire fixation or plate fixation. Patients will be evaluated over a one year period following their surgery.
详细描述
Background
Proximal forearm fractures comprise approximately 5% of all fractures, whilst olecranon fractures account for almost 20% of fractures occurring around the elbow1. There is limited conclusive evidence regarding the epidemiology, optimal treatment and outcome of isolated olecranon fractures.
Patients with undisplaced olecranon fractures can be treated non-operatively2,3. The aims of treatment in displaced olecranon fractures are the restoration of function and stability to the elbow joint4. The technique employed should allow preservation and reconstruction of the articular surface with minimal associated complications. Tension-band wiring (TBW) is the most recognised and commonly used fixation method, although plate fixation and intramedullary screw fixation are noted alternatives2,4-10. Potential problems with the TBW technique are wound breakdown, infection, prominent metalwork, malunion and non-union2,4,7,11-13. Furthermore, plate fixation is considered to be superior in distal/comminuted/oblique fractures and fracture-dislocations, with superior fracture reduction and fixation results, as well as a lower rate of re-operation2,5,13,14. There is only one prospective randomized trial in the literature comparing TBW and plate fixation for displaced olecranon fracture13. The major conclusions from this study were:
- The functional outcome at six months was not significantly different in the two groups
- Post-operative loss of fracture reduction (53% vs 5%) and prominent symptomatic metalwork was more frequently observed after TBW
This study was performed in 1992 with less sophisticated plates when compared with the location specific plates currently available.
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
- 16 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥16 years to <75yrs
- •Minimal/moderate fragmentation of the olecranon
- •Within two weeks of olecranon fracture
排除标准
- •Pregnant women with pre-determined treatment
- •Patients unable to give informed consent
- •Associated fractures to the coronoid, radial head and/or distal humerus
- •Associated ligamentous injury, dislocation or subluxation
- •Open fractures
结局指标
主要结局
DASH
时间窗: One year
Patient rated outcome measure - DASH questionnaire at one year post injury/surgery.
次要结局
- Time taken to return to activities(One year)
- Range of motion(One year)
- Mayo Elbow Performance Index (MEPI)(One year)
- Pain(One year)
- Radiographic Assessment(Six months)
研究者
Andrew D Duckworth
StR
Royal Infirmary of Edinburgh