Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Rotation
研究概览
简要总结
The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implant section that protrudes from the soft parts.
The benefits of using an osseointegrated prosthesis are the improved sensory feedback (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis to the abutment, greater control of the prosthesis and the absence of heat, pain, and pressure sores.
The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good growth of bone and muscle mass. The aim of this study is to evaluate the stability of the osseointegrated implant in trans-femoral and trans-humeral amputees.
The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and follow-up.
The secondary outcome: evaluation of the quality of life improvement in patients through clinical score and satisfaction survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI<35 kg/m2
- •Problem in using socket
排除标准
- •Diabetes;
- •Peripheral vascular diseases;
- •Psychiatric problems;
- •Pregnancy;
- •Rheumatoid arthritis;
- •Neurovascular diseases;
- •Neurological deficits;
- •Amputation of the contralateral limb;
- •Infections in progress;
- •Immunosuppression;
结局指标
主要结局
Rotation
时间窗: 24 months
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Translation
时间窗: 24 months
Translations X, Y, Z (in mm) of the implant with respect to the bone
次要结局
- Lower limb: Autonomy(24 months)
- Health-related quality of life(24 months)
- lower limb: Mobility(4 months)
- Pain evaluation(24 months)
- Upper limb: functionality(24 months)
- Upper Limb: Development and evaluation of the activities measure for upper limb amputees(24 months)
研究者
Stefano Zaffagnini
Full Professor and Head of department
Istituto Ortopedico Rizzoli