Longevity and effectiveness of 3D-printed transtibial prosthetic sockets in rural Sierra Leone: A pilot study with 2.5-year follow-up.

Abstract

Prosthetic care is limited in low- and middle-income countries. Finding solutions to improve prosthetic accessibility is commendable, and 3D printing presents a potential solution. To evaluate the durability and usage of 3D-printed transtibial prosthetic sockets, as well as to assess the impact of these prostheses on participants' functioning and health-related quality of life (HRQoL). A longitudinal cohort study with 2.5 year follow-up. Participants received a locally manufactured transtibial prosthesis with a 3D-printed prosthetic socket at the 3D Lab at Masanga Teaching Hospital in Sierra Leone. Baseline, 10-week, 9-month, 1.5-year, and 2.5-year follow-up assessments included (1) quantifying prosthetic longevity, (2) prosthetic use using activity sensors, (3) lower extremity functional status using the adopted Orthotics and Prosthetics User's Survey (OPUS) (range: 0-60), (4) disease-specific health-related quality of life using the adapted OPUS survey (range: 0-36), and (5) generic health-related quality of life using EQ-5D-3L (range: -0.145 to 0.9) and visual analog scale score (range: 0-10). Nine participants participated in the study. Six prosthetic sockets exhibited damage after 361, 398, 399, 553, 641, and 756 days. One participant used the prosthesis for 2.5 years, another had their socket replaced due to socket size problems, and one was lost to follow-up. At 2.5 years, the median wear time was 12.4 (11.4-13.5) hours daily, with 6906 steps (4277-9792), 65% (51%-82%) while wearing the prosthesis. Median scores at follow-up compared with baseline were as follows: OPUS Function (47-55 points), OPUS disease-specific health-related quality of life (17-34 points), EQ-5D-3L (0.741-0.744), and visual analog scale (6-10 points). Most prostheses were extensively used. The study underscores the need for research on enhancing the durability of 3D-printed sockets.