A Personalized 3D-Printed Smart Splint with Integrated Sensors and IoT-Based Control: A Proof-of-Concept Study for Distal Radius Fracture Management

Conventional static fixation for distal radius fractures (DRF) is clinically challenging, with methods often leading to complications such as malunion and pressure-related injuries. These issues stem from uncontrolled pressure and a lack of real-time biomechanical feedback, resulting in suboptimal functional recovery. To overcome these limitations, we engineered an intelligent, adaptive orthopedic device. The system is built on a patient-specific, 3D-printed architecture for a lightweight, personalized fit. It embeds an array of thin-film pressure sensors at critical anatomical sites to continuously quantify biomechanical forces. This data is transmitted via an Internet of Things (IoT) module to a cloud platform, enabling real-time remote monitoring by clinicians. The core innovation is a closed-loop feedback controller governed by a robust Interval Type-2 Fuzzy Logic (IT2-FLC) algorithm. This system autonomously adjusts servo-driven straps to dynamically regulate fixation pressure, adapting to changes in limb swelling. In a preliminary clinical evaluation, the group receiving the integrated treatment protocol, which included the smart splint and TCM herbal therapy, demonstrated superior anatomical restoration and functional recovery, evidenced by higher Cooney scores (91.65 vs. 83.15) and lower VAS pain scores. This proof-of-concept study validates a new paradigm for adaptive orthopedic devices, showing high potential for clinical translation.