Early Clinical Outcomes, Comfort, and Satisfaction With Customized 3D-Printed PLA Transtibial Sockets: A Prospective Pilot Study

Background: Fused Deposition Modeling (FDM) using Polylactic Acid (PLA) may support transtibial socket fabrication, but evidence remains limited regarding short-term patient-centered responses, wear time, and safety. This study evaluated socket comfort, residual-limb pain, satisfaction, wear time, and adverse events over 28 days. Methods: This single-arm, uncontrolled, pre-experimental repeated-measures pilot study purposively recruited 30 adults with unilateral transtibial amputation in Central Java, Indonesia. The primary outcome was Socket Comfort Score (SCS); secondary outcomes included residual-limb pain, satisfaction with the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), wear time, and adverse events. SCS and residual-limb pain were assessed at T0 and days 7, 14, 21, and 28. Inferential analyses used 29 complete cases; descriptive and safety summaries included 30. Friedman and Wilcoxon signed-rank tests were used. Results: Median SCS increased from 5.3 (interquartile range [IQR] 4.7-6.2) at T0 to 6.1 (IQR 5.4-7.3) at day 28 (W = 60; p < 0.001; r = 0.63). Residual-limb pain decreased from 3.5 (IQR 2.8-4.2) to 3.0 (IQR 1.7-3.8) (W = 58; p < 0.001; r = 0.61). Day-28 QUEST 2.0 satisfaction was 3.98 ± 0.36/5 and wear time was 8.49 ± 1.68 hours/day. Nine participants experienced mild observed clinical adverse events; all resolved with conservative management. Inferential analyses used 29 complete cases, whereas descriptive and adverse-event summaries included all 30 participants. Conclusion: Customized FDM-printed PLA transtibial sockets demonstrated promising short-term clinical feasibility and tolerability over 28 days, with improved socket comfort, reduced residual-limb pain, substantial wear time, and no observed serious clinical adverse events. These findings do not establish causal effectiveness, superiority, mechanical or structural safety, durability, or long-term safety, and the satisfaction findings require cautious interpretation because a validated Indonesian-language QUEST 2.0 was not available.