Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain: Patient-rated
研究概览
简要总结
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery.
详细描述
Background: Previous studies document that 75% of traumatic amputees in low-income countries develop incapacitating chronic pain syndromes. With the present level of rehabilitation service, amputees have to wait 4-6 months for postoperative prosthesis fitting.
Hypothesis: Immediate postoperative prosthesis fitting reduce chronic pain and improves function in trans-tibial amputees.
Reference population: Traumatic amputees living in low-income and low-resource communities.
Study population: Adult patients with trans-tibial amputations in rural districts of Battambang Province, Cambodia.
Study design: A semi-cross over controlled study. Supplement:longitudinal qualitative studies of subsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic transtibial amputation
排除标准
- •Double amputation
结局指标
主要结局
Pain: Patient-rated
时间窗: 1, 3, and 6 months postinjury
Pain: clinical exam rated
时间窗: 1, 3, and 6 months post-injury
Function: patient-rated
时间窗: 1, 3, and 6 months post-injury
Function: gait analysis
时间窗: 1, 3, and 6 months post-injury
次要结局
- Qualitative longitudinal study of subsets(1, 3, and 6 months post-injury)