AI-Powered Research

- 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pain level as rated on a VAS scale<br /><br>- Distance/speed of walking assessed using the 6 Minutes Walking Test<br /><br>- Patient's quality of life assessed using the Prosthesis Evaluation<br /><br>Questionnaire and the SF-36<br /><br>- Implant failure assessed using the number of Serious Adverse Events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Bone mineral density assessed using bone densitometry<br /><br>- Hours of daily prosthetic use assessed using Houghton scale and a diary to<br /><br>keep track of prosthetic usage<br /><br>- Oxygen consumption during walking assessed using aerobic ergometry<br /><br>- Timed up and go test<br /><br>- Use of walking aids<br /><br>- Hip range of motion assessed using a goniometer<br /><br>- Number and type of skin and stump problems<br /><br>- Spatiotemporal, kinematic, and kinetic variables of walking assessed using an<br /><br>opto-electronic gait analysis system<br /><br>- Muscle activation patterns assessed using electromyography</p><br>