Status:
COMPLETED
An Investigation Into a New Manufacture Technique of Trans-femoral Sockets
Lead Sponsor:
Össur Iceland ehf
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL). Device(s) being tested: Interchan...
Detailed Description
The test will be a single group prospective pre/post design. Amputees are a small proportion of the general population. The population group specified in the inclusion/exclusion criteria is a further ...
Eligibility Criteria
Inclusion
- Cognitive ability to understand all instructions and questionnaires in the study.
- Patients who have undergone a trans-femoral amputation \> 1 year post amputation.
- Willing and able to participate in the study and follow the protocol.
- Circular dimension of 40-65 cm at the crotch.
- Residual limb length at least 20 cm from ischium to distal end.
Exclusion
- 50Kg \> body weight \> 160Kg
- Users with cognitive impairment
- Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04312724
Start Date
April 30 2018
End Date
July 1 2020
Last Update
November 20 2020
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Artificial Limb Specialists
Mobile, Alabama, United States, 36606
2
Alabama Artificial Limb Specialists
Montgomery, Alabama, United States, 36116
3
Alabama Artificial Limb Specialists
Opelika, Alabama, United States, 36801
4
Van Der Watt Prosthetics & Orthotics
Greenwood, Arkansas, United States, 72936