NL-OMON46756尚未招募4 期
Randomized prospective evaluation of the clinical use of the Keep Walking Femoral Implant in European countries - Randomized evaluation Keep Walking Femoral Implant
Revalidatiecentrum Het Roessingh0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Have been indicated for a transfemoral amputation due to traumatic, vascular, or oncologic aetiology;
- •- In case of vascular aetiology: presence of femoral pulse with no significant stenosis (percentage of stenosis lower than 60%) and PPCI hemodynamic index below 0.25;
- •- Have the ability to bear weight on the contralateral (intact) leg during at least 10 seconds, with or without using technical aids;
- •- Have functional walking ability between 8-12 weeks prior to the amputation, with or without technical aids;
- •- Have a residual femur length of at least 14 centimetre measured from the greater trochanter.
排除标准
- •Absolute contraindications
- •- Age <18 years
- •- Active neoplasia pathology
- •- Currently undergoing chemotherapy treatment
- •- Currently using immunosuppressant
- •- Sepsis or active infection
- •- Residual length of the femur less than 12 cm measured from the greater trochanter
- •- Pregnancy
- •- Alcohol or drug addiction
- •- Alterations of the central nervous system (CNS): dementia, cerebral tumours, degenerative pathology etc.
- •- Patient that does not consent to participation in the study
- •- Psychiatric disorders
- •- Allergy to any of the components of the implant;Relative contraindications
- •- Severe osteopenia or osteoporosis (cortical bone thickness less than 3 mm)
- •- Previous infection of the stump
- •- Deformity in hip flexion greater than 300
- •- Residual length of the femur between 12 and 14 cm measured from the greater trochanter.
研究者
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