Clinical efficacy of a patient-specific 3D-printed reduction brace for tibial shaft fractures: a prospective randomized controlled trial
- 1School of Orthopedics and Traumatology, Henan University of Chinese Medicine, Zhengzhou, China
- 2Luoyang Orthopedic Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Luoyang, China
Abstract
PurposeTo preliminarily compare the perioperative and short-term clinical outcomes of a patient-specific 3D-printed reduction brace–based fixation strategy and conventional intramedullary nailing for tibial shaft fractures.MethodsThis single-center prospective randomized controlled trial included 30 patients with closed AO/OTA type 42 tibial shaft fractures enrolled between September 2025 and February 2026. Follow-up data available through June 24, 2026, were included in the present analysis. Patients were randomly assigned using a random number table to either the patient-specific 3D-printed reduction brace group (n = 15) or the intramedullary nail group (n = 15). Due to loss to follow-up, 13 patients in the 3D-printed reduction brace group and 15 patients in the intramedullary nail group completed the prespecified 3-month clinical assessment. Operative time, intraoperative fluoroscopy frequency, blood loss, postoperative Visual Analog Scale (VAS) scores, time to first documented healing, functional outcomes, and complications were compared between groups. Perioperative and 1-week outcomes were analyzed in all 30 randomized participants. Healing and other later follow-up outcomes were analyzed using available cases according to randomized allocation; a censored time-to-event analysis retained all randomized participants as a sensitivity analysis.ResultsOperative time was shorter in the brace group by 18.80 minutes (95% CI, 11.21–26.39 minutes), with 1.60 fewer fluoroscopic exposures (95% CI, 0.87–2.33) and 37.87 mL less intraoperative blood loss (95% CI, 23.39–52.34 mL). The 1-week VAS score was lower (Hodges–Lehmann shift, −1.00; 95% CI, −2.00 to −1.00). Among the 28 participants with follow-up data, time to first documented healing was shorter in the brace group (Hodges–Lehmann shift, −2.00 weeks; 95% CI, −2.00 to −1.00 weeks). No statistically significant between-group differences were observed in residual fracture-site displacement classification or 3-month Johner–Wruhs functional outcomes. Sensitivity analyses did not materially change the conclusions.ConclusionsIn this small exploratory trial, the brace-based fixation strategy was associated with more favorable perioperative outcomes, less early postoperative pain, and shorter time to first documented healing than intramedullary nailing. However, these preliminary findings compare two different fixation strategies and do not establish the independent clinical superiority of the 3D-printed brace. Larger multicenter studies with longer follow-up are warranted.Trial RegistrationThe study was registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN10781625). The trial registration record is available at https://www.isrctn.com/ISRCTN10781625.
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BibTeX
@article{teng2026clinical,
title = {{Clinical efficacy of a patient-specific 3D-printed reduction brace for tibial shaft fractures: a prospective randomized controlled trial}},
author = {Xiaohui Teng and Xiaohui Teng and Yidan Yang and Yidan Yang and Weize Zhang and Weize Zhang and Yingjie Zhu and Leilei Zhang and Youwen Liu},
journal = {Frontiers in Medicine},
year = {2026},
month = nov,
doi = {10.3389/fmed.2026.1960596},
url = {https://doi.org/10.3389/fmed.2026.1960596},
note = {CC BY},
}
RIS
TY - JOUR
TI - Clinical efficacy of a patient-specific 3D-printed reduction brace for tibial shaft fractures: a prospective randomized controlled trial
AU - Xiaohui Teng
AU - Xiaohui Teng
AU - Yidan Yang
AU - Yidan Yang
AU - Weize Zhang
AU - Weize Zhang
AU - Yingjie Zhu
AU - Leilei Zhang
AU - Youwen Liu
PY - 2026
DA - 2026/11/04
JO - Frontiers in Medicine
DO - 10.3389/fmed.2026.1960596
UR - https://doi.org/10.3389/fmed.2026.1960596
AB - PurposeTo preliminarily compare the perioperative and short-term clinical outcomes of a patient-specific 3D-printed reduction brace–based fixation strategy and conventional intramedullary nailing for tibial shaft fractures.MethodsThis single-center prospective randomized controlled trial included 30 patients with closed AO/OTA type 42 tibial shaft fractures enrolled between September 2025 and February 2026. Follow-up data available through June 24, 2026, were included in the present analysis. Patients were randomly assigned using a random number table to either the patient-specific 3D-printed reduction brace group (n = 15) or the intramedullary nail group (n = 15). Due to loss to follow-up, 13 patients in the 3D-printed reduction brace group and 15 patients in the intramedullary nail group completed the prespecified 3-month clinical assessment. Operative time, intraoperative fluoroscopy frequency, blood loss, postoperative Visual Analog Scale (VAS) scores, time to first documented healing, functional outcomes, and complications were compared between groups. Perioperative and 1-week outcomes were analyzed in all 30 randomized participants. Healing and other later follow-up outcomes were analyzed using available cases according to randomized allocation; a censored time-to-event analysis retained all randomized participants as a sensitivity analysis.ResultsOperative time was shorter in the brace group by 18.80 minutes (95% CI, 11.21–26.39 minutes), with 1.60 fewer fluoroscopic exposures (95% CI, 0.87–2.33) and 37.87 mL less intraoperative blood loss (95% CI, 23.39–52.34 mL). The 1-week VAS score was lower (Hodges–Lehmann shift, −1.00; 95% CI, −2.00 to −1.00). Among the 28 participants with follow-up data, time to first documented healing was shorter in the brace group (Hodges–Lehmann shift, −2.00 weeks; 95% CI, −2.00 to −1.00 weeks). No statistically significant between-group differences were observed in residual fracture-site displacement classification or 3-month Johner–Wruhs functional outcomes. Sensitivity analyses did not materially change the conclusions.ConclusionsIn this small exploratory trial, the brace-based fixation strategy was associated with more favorable perioperative outcomes, less early postoperative pain, and shorter time to first documented healing than intramedullary nailing. However, these preliminary findings compare two different fixation strategies and do not establish the independent clinical superiority of the 3D-printed brace. Larger multicenter studies with longer follow-up are warranted.Trial RegistrationThe study was registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN10781625). The trial registration record is available at https://www.isrctn.com/ISRCTN10781625.
SN - 2296-858X
ER -