Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol
概览
- 阶段
- 不适用
- 干预措施
- Medacta femoral prosthesis
- 疾病 / 适应症
- Trans-femoral Amputated Patients
- 发起方
- Christian Candrian
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Quality of Life
- 状态
- 终止
- 最后更新
- 上个月
概览
简要总结
Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed to implant a new developed prosthesis.
详细描述
The patients will undergo a surgical operation to implant a femoral prosthesis according to the hospital's protocol. The surgical intervention will be performed under general or spinal anesthesia with a tourniquet at the root of the lower limb. Under sterile conditions, the incision of the stump will be done at the level of the previous surgical scar. Preserving the soft tissue, the distal femoral bone is reached. Then, the medullary canal is opened and prepared with reamers of increasing diameter. A femoral cemented stem of appropriate dimensions correlated to the size of the canal and 105 mm of height is implanted. To the above-mentioned stem, the Medacta prosthesis will be fixed with a blocking screw. The prosthesis is then covered with the soft tissue and layered suturing of the stump is performed.
研究者
Christian Candrian
MD
Ente Ospedaliero Cantonale, Bellinzona
入排标准
入选标准
- •Age \>18 and \<75 years
- •Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score \< 60 or an SF-36 result below the 50th percentile
- •Amputation due to:
- •Oncologic disease
- •Written informed consent
排除标准
- •Trans-femoral amputation due to infection
- •Patients affected by
- •metabolic disease
- •neurologic degenerative disease
- •vascular disease proximal to the amputation
- •body weight \>100 kg
- •Hip arthritis of the amputated limb
研究组 & 干预措施
Femoral prosthesis
newly developed prosthesis for trans-femoral amputation
干预措施: Medacta femoral prosthesis
结局指标
主要结局
Quality of Life
时间窗: Two years
Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L
次要结局
- Adverse Events(Two years)