Status:
RECRUITING
Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients
Lead Sponsor:
Christian Candrian
Conditions:
Trans-femoral Amputated Patients
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03445481
Start Date
February 20 2018
End Date
December 31 2027
Last Update
August 6 2025
Active Locations (1)
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1
Ospedale Regionale di Lugano Civico e Italiano
Lugano, Switzerland, 6900