Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Bone healing
研究概览
简要总结
To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.
详细描述
Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p<0.05 was considered statistically significant.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient aged between 18 and 65 years;
- •acute fractures within 15 days;
- •closed fractures or fractures with small open wound less than 1.5 cm;
- •involvement of single middle phalanges of index to little fingers;
- •shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured;
- •transversal, short oblique or spiral fractures;
- •comminuted fractures of middle third phalanx;
- •normal opposite hand for comparison.
排除标准
- •patients younger than 18 years are excluded because of skeletal immaturity;
- •patients older than 65 years are excluded because of possible osteoporosis;
- •multiple finger involvement; severe open injury or crush injuries;
- •combined tendon or neurovascular injuries; involvement of articular surface;
- •old fractures exceeding 15 days because close reduction most likely became difficult;
- •combined tendon, nerve, or artery injuries or diseases;
- •diabetes, gout, ganglion;
- •osseous tumors, and other disease affecting bony structures and joint motion;
- •patients who declined to participate.
结局指标
主要结局
Bone healing
时间窗: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.
Time of bone healing
次要结局
- Joint motion(Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.)