Trans-femoral Amputated Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMedacta femoral prosthesis
patients' treatment with a new implant prosthesis
Sponsors
Christian Candrian
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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: 1. Trauma 2. Oncologic disease * Written informed consent
Exclusion criteria
* Trans-femoral amputation due to infection * Patients affected by 1. metabolic disease 2. neurologic degenerative disease 3. vascular disease proximal to the amputation 4. body weight \>100 kg 5. Hip arthritis of the amputated limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Two years | Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Two years | Post surgery adverse events collecting adverse events |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORChristian Candrian, Dr. med
EOC
Outcome results
None listed