Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 24
- 主要终点
- Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score
研究概览
简要总结
Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.
Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.
Primary hypothesis:
In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years with a metacarpal V neck fracture with a palmar angulation and/or shortening and /or rotational deformity as determined on radiological diagnosis
- •Trauma within 10 days before appearing in the study centre
- •No specific medical treatment before
- •Ability to fully understand the character and implications of the clinical trial
- •Written or oral (in case of an injury of the dominant hand, if so attested by witnesses)consent
排除标准
- •Indications for conservative therapy
- •Patient is not suitable for anaesthesia
- •Other physical conditions or characteristics which made surgical interventions inappropriate or to risky (e.g. open fractures, polytrauma, pregnancy, acute infections, pathological fractures)
- •Prior participation in this study (e.g. injury of the contralateral hand) or participation in other interventional studies with the same objective
- •Physical or mental diseases which makes the consequent participation in diagnostic, therapy and the follow-up-examinations unlikely
- •Lacking language skills
研究组 & 干预措施
Single Kirschner Wire
Antegrade intramedullary fixation of with a single Kirschner wire.
干预措施: Single Kirschner Wire (Device)
Double Kirschner Wire
Antegrade intramedullary fixation with double Kirschner wire.
干预措施: Double Kirschner Wire (Device)
结局指标
主要结局
Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score
时间窗: 6 months after randomisation
次要结局
- Flexion or extension lag(6 months after randomisation)
- Pain intensity <10 points (VAS)(6 months after randomisation)
- Rate of perforation/dislocation/break of the fracture fixation devices(6 months after randomisation)
- Duration of inability to work(6 months after randomisation)
- Shortening of the metacarpus >2mm(6 months after randomisation)
- Palmar angulation >30°(6 months after randomisation)
- Non-union/Pseudarthrosis(6 months after randomisation)
- Duration of surgical intervention(6 months after randomisation)
- Limitation of fist closure(6 months after randomisation)
- Rate of infections(6 months after randomisation)
- Malposition or angulation in the frontal and sagittal planes of max. 5°(6 months after randomisation)
- Rate of re-interventions(6 months after randomisation)
研究者
Prof. Dr. Andreas Eisenschenk
Prof. Dr.
University Medicine Greifswald