Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 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. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
详细描述
Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
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 fracture or open injury with small wound less than 1.5 cm;
- •involvement of proximal phalanges of index to little fingers; shaft fractures;
- •at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged;
- •oblique, spiral, and comminuted fractures;
- •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;
- •severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface;
- •old fractures exceeding 15 days because close reduction was most likely difficult;
- •a 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.)