Clinical efficacy of a patient-specific 3D-printed reduction brace for tibial shaft fractures: a prospective randomized controlled trial

Purpose To 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. Methods This 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. Results Operative 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. Conclusions In 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 Registration The 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 .