Volar Locked Plating Versus Bridging External Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Quick-DASH
研究概览
简要总结
A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3.
Hypothesis:
There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.
详细描述
We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).
- •All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion.
排除标准
- •Gustillo-Anderson type III open fractures
- •Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
- •Congenital anomaly
- •Bilateral radius fracture
- •Pathological fracture other than osteoporotic fracture
- •Congenital bone disease (for example osteogenesis imperfecta)
- •Age below 18 and above 70
- •Disabling nury to other parts og the movement apparatus at the same time as the current injury
结局指标
主要结局
Quick-DASH
时间窗: 2 year follow-up
次要结局
未报告次要终点
研究者
Ola-Lars Hammer
PhD-student
University Hospital, Akershus