Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions

CompletedOBSERVATIONAL
Enrollment

27

Participants

Timeline

Start Date

July 8, 2019

Primary Completion Date

March 12, 2020

Study Completion Date

November 30, 2020

Conditions
Transtibial Amputees
Interventions
DEVICE

Amparo Confidence Socket

"The Amparo Confidence Socket technology takes a different approach by starting with a prefabricated socket (https://www.amparo.world/confidence-socket-en). The socket is made from a moldable thermoplastic and has the attachment point pre-assembled. This prefabricated socket is essentially an off-the-shelf product that can be heated, then molded directly to the patient's residual limb. This removes many of the intermediate steps in traditional socket fabrication. The product's molding temperature is between 60-70 ˚C but the insulation of a silicone liner between the plastic and limb ensures safe temperatures for the patient. This process is currently used in several workshops in Europe and with approximately 50 patients currently using the product. In general, it has been shown to be safe and effective in creating below-knee prosthesis."

Trial Locations (2)

80100

Association for the Physically Disabled of Kenya (APDK), Mombasa

Unknown

AIC CURE International Hospital Kenya, Kijabe

All Listed Sponsors
collaborator

GDI Hub

UNKNOWN

collaborator

AT 2030

UNKNOWN

lead

Amparo GmbH

INDUSTRY

NCT04679701 - Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions | Biotech Hunter | Biotech Hunter