Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 主要终点
- Disability as measured by Disability of Arm, Shoulder and Hand Score
研究概览
简要总结
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
详细描述
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.
The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has an unstable extra-articular metacarpal fracture that meets operative indications
- •Informed consent is obtained from the patient or proxy
- •Male or female who are 16 years of age or older
排除标准
- •If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
- •Pathological Fracture
- •Greater than 21 days from fracture to definitive open reduction and internal fixation
- •If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
- •Highly comminuted diaphyseal fractures
- •Articular fractures
- •Multiple fractures involving bones other than another metacarpal in the same upper extremity
- •The patient had a previous upper extremity injury that has limited hand function or finger range of motion
研究组 & 干预措施
Buried Intramedullary K-wire Fixation
Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire.
干预措施: Buried Intramedullary K-wire Fixation (Procedure)
Plate and Screw Fixation
Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion.
干预措施: Plate and Screw Fixation (Procedure)
结局指标
主要结局
Disability as measured by Disability of Arm, Shoulder and Hand Score
时间窗: 3 months
次要结局
- Total Active Motion in degrees(3 months)
- Disability as measured by Disability of Arm, Shoulder and Hand Score(1 year)
- Grip Strength(3 months)