A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 主要终点
- Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed
研究概览
简要总结
A randomized clinical trial, with patients treated either by a custom thermoplastic orthosis or by the Kirschner wire with the distal interphalangeal (DIP) joint extended.
Evaluating the treatment efficacy of the operation management compared with a conventional orthosis.
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
- 是
入选标准
- •Diagnosis of a mallet finger, with or without fracture;
- •Age≥18 years
排除标准
- •Open lesions
- •Mallet fractures with subluxation of the DIP
- •Delays in treatment >2 weeks
结局指标
主要结局
Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed
时间窗: The first visit(Enrolled and completed treatment), 8 weeks after first visit(two weeks after 6 weeks fixation), 16 weeks(4 weeks after six weeks Rehabilitation)
Use a Protractor to measure the maximum degree of active flexion of the DIP joint at the first visit and at the end treatment; Use a Protractor to measure the maximum degree of active extension of the DIP joint at the start of immobilization and end of treatment. (If the maximum degree of active flexion of two time periods are 40° and 40°，respectively; the maximum degree of active extension of two time periods are 20° and -10°，respectively. We could get the range of motion of the DIP joint of two time periods are 20°\~40° and -10°\~40°，respectively. The maximum extension angle increased by 30 degrees).To assess whether there was a statistical difference in ROM changes between the two groups before and after treatment.
次要结局
未报告次要终点