3D-Printed Hand Splints versus Thermoplastic Splints: A Randomized Controlled Pilot Feasibility Trial
In this randomized controlled pilot trial, we compared three-dimensional (3D)-printed made-to-measure splints to conventional custom-made thermoplastic splints. In a clinical setting, we evaluated their general applicability and possible benefits for immobilization in hand surgical patients. We included 20 patients with an indication for immobilization of at least 4 weeks, regardless of the splint design. Patient comfort and satisfaction were assessed with questionnaires at splint fitting, as well as 2 and 4–6 weeks later. The 3D splints were designed and printed in-house with polylactic acid from a 3D surface scan. Our data suggest that 3D-printed splinting is feasible, and patient satisfaction ratings were similar for 3D-printed and thermoplastic splints. The 3D splint production process needs to be optimized and other materials need to be tested before routine implementation is possible or more patients can be enrolled in further studies. Validated quality assessment tools for current splinting are lacking, and further investigation is necessary
1. de Souza MA, Schmitz C, Marega Pinhel M, et al., 2017, Proposal of Custom Made Wrist Orthoses Based on 3D Modelling and 3D Printing. Annu Int Conf IEEE Eng Med Biol Soc, 2017:3789–92. https://doi.org/10.1109/EMBC.2017.8037682
2. Baronio G, Harran S, Signoroni A, 2016, A Critical Analysis of a Hand Orthosis Reverse Engineering and 3d Printing Process. Appl Bionics Biomech, 2016:8347478. https://doi.org/10.1155/2016/8347478
3. Blaya F, Pedro PS, Silva JL, et al., 2018, Design of an Orthopedic Product by Using Additive Manufacturing Technology: The Arm Splint. J Med Syst, 42:54. https://doi.org/10.1007/s10916-018-0909-6
4. Chu CH, Wang IJ, Sun JR, et al., 2020, Customized Designs of Short Thumb Orthoses Using 3D Hand Parametric Models. Assist Technol, 7:1-8 https://doi.org/10.1080/10400435.2019.1709917
5. Lee KH, Kim DK, Cha YH, et al., 2019, Personalized Assistive Device Manufactured by 3D Modelling and Printing Techniques. Disabil Rehabil Assist Technol, 14:526–31. https://doi.org/10.1080/17483107.2018.1494217
6. Li J, Tanaka H, 2018, Rapid Customization System for 3D-Printed Splint Using Programmable Modeling Technique-a Practical Approach. 3D Print Med, 4:5. https://doi.org/10.1186/s41205-018-0027-6
7. Nam HS, Seo CH, Joo SY, et al., 2018, The Application of three-Dimensional Printed Finger Splints for Post Hand Burn Patients: A Case Series Investigation. Ann Rehabil Med, 42:634–8. https://doi.org/10.5535/arm.2018.42.4.634
8. Paterson A, Bibb R, Campbell RI, 2012, Evaluation of a Digitised Splinting Approach with Multiple-Material Functionality Using Additive Manufacturing Technologies. In: Bourell D, Crawford RH, Seepersad CC, et al., (Eds.), Proceedings of the 23rd Annual International Solid Freeform Fabrication Symposium-An Additive Manufacturing Conference, University of Texas at Austin, Austin, p656–72.
9. Paterson A, Bibb R, Campbell RI, et al., 2015, Comparing Additive Manufacturing Technologies for Customised Wrist Splints. Rapid Prototyp J, 21:230–43.
10. Sari MI, Sahin I, Gokce H, et al., 2020, Ring Orthosis Design and Production by Rapid Prototyping Approach. J Hand Ther, 33:170–3. https://doi.org/10.1016/j.jht.2019.02.003
11. Cazon A, Kelly S, Paterson AM, et al., 2017, Analysis and Comparison of Wrist Splint Designs Using the Finite Element Method: Multi-Material Three-Dimensional Printing Compared to Typical Existing Practice with Thermoplastics. Proc Inst Mech Eng H, 231:881–97. https://doi.org/10.1177/0954411917718221
12. Hoogervorst P, Knox R, Tanaka K, et al., 2019, A Biomechanical Comparison of Fiberglass Casts and 3-Dimensional-Printed, Open-Latticed, Ventilated Casts. Hand (NY), 16:842–9. https://doi.org/10.1177/1558944719831341
13. Graham J, Wang M, Frizzell K, et al., 2018, Conventional vs 3-Dimensional Printed Cast Wear Comfort. Hand (NY), 15:388–92. https://doi.org/10.1177/1558944718795291
14. Zheng Y, Liu G, Yu L, et al., 2020, Effects of a 3D-Printed Orthosis Compared to a Low-Temperature Thermoplastic Plate Orthosis on Wrist Flexor Spasticity in Chronic Hemiparetic Stroke Patients: A Randomized Controlled Trial. Clin Rehabil, 34:194–204. https://doi.org/10.1177/0269215519885174
15. Chen YJ, Lin H, Zhang X, et al., 2017, Application of 3D-Printed and Patient-specific Cast for the Treatment of Distal Radius Fractures: Initial Experience. 3D Print Med, 3:11. https://doi.org/10.1186/s41205-017-0019-y
16. Guida P, Casaburi A, Busiello T, et al., 2019, An Alternative to Plaster Cast Treatment in a Pediatric Trauma Center using the CAD/CAM Technology to Manufacture Customized Three-Dimensional-Printed Orthoses in a Totally Hospital Context: A Feasibility Study. J Pediatr Orthop B, 28:248–55. https://doi.org/10.1097/BPB.0000000000000589
17. Heinemann AW, Bode RK, O’Reilly C, 2003, Development and measurement properties of the Orthotics and Prosthetics Users’ Survey (OPUS): A Comprehensive Set of Clinical Outcome Instruments. Prosthet Orthot Int, 27:191–206. https://doi.org/10.1080/03093640308726682
18. Nofar M, Sacligil D, Carreau PJ, et al., 2019, Poly (Lactic Acid) Blends: Processing, Properties and Applications. Int J Biol Macromol, 125:307–60. https://doi.org/10.1016/j.ijbiomac.2018.12.002