Benefits and durability of an affordable prosthetic silicone cushion liner locally manufactured in a resource-limited environment: Enabling adoption of total surface bearing sockets and silicone cushion liners.

Only 12 of 17 participants completed the study, limiting the reliability of the findings. The study duration was only 3 months, so long-term effects on mobility and skin health are unknown. The new prosthesis included two changes at once: the silicone liner and the TSB socket design. It is impossible to separate which change caused the improvement in walking. Participants did not have leprosy, so results may not apply to patients with loss of sensation who are at higher risk for ulcers. The modified satisfaction questionnaire used was not validated. The TSB socket was used without a suspension sleeve, which is not typical for this design and may have affected comfort and performance.

The study was supported by Operation Namaste, a non-profit organization involved in the design and manufacture of the liner. The authors include researchers from this organization.

Do not assume the silicone liner alone caused the improved walking. The study changed both the liner and the socket design simultaneously, so the benefit could be due to the socket, the liner, or both.