Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol

Conditions
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Trans-femoral Amputated Patients

Intervention / Treatment
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* Device: Medacta femoral prosthesis


Participation Criteria
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Eligibility Criteria
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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: Trauma Oncologic disease Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femoral prosthesis<br>newly developed prosthesis for trans-femoral amputation | Device: Medacta femoral prosthesis<br>* patients' treatment with a new implant prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Post surgery adverse events collecting adverse events | Two years |