Osseointegrated Prostheses for the Rehabilitation of Amputees.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Q-TFA Prosthetic Use Score
研究概览
简要总结
Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4. The potential for improvement is substantial. Based on the very good long-term results with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical trial began.
The hypothesis is that the treatment will improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transfemoral amputation
排除标准
- •Transfemoral amputation due to vascular disease
研究组 & 干预措施
Implant System
干预措施: OPRA Implant System (Device)
结局指标
主要结局
Q-TFA Prosthetic Use Score
时间窗: 0,1,2,3,5,7,10,15,20 years
The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.
次要结局
未报告次要终点