Efficacy of the use of 3D printing models in the treatment of tibial plateau fractures: a pilot randomized clinical trial

BACKGROUND: Tibial plateau fractures are complex injuries requiring precise preoperative planning. Three-dimensional (3D) printing has emerged as a valuable tool to enhance fracture visualization and surgical decision-making. The objective of this study was to evaluate whether preoperative planning assisted by 3D-printed models improves operative efficiency and clinical outcomes in tibial plateau fracture surgery, compared to conventional imaging. METHODS: A randomized clinical trial was conducted including 35 patients with surgically treated tibial plateau fractures. Participants were assigned to standard planning based on radiographs and CT (control group) or to 3D-assisted planning using a patient-specific printed model (3D group). Primary outcomes were operative time and intraoperative fluoroscopy time. Secondary outcomes included complication rates, range of motion, pain, patient-reported outcomes (KOOS, EQ-5D, WOMAC), and radiological results (Rasmussen score). Surgeons in the 3D group completed a questionnaire to assess changes in preoperative strategy due to the model. RESULTS: 33 patients were analyzed (18 in 3D group, 15 in control). The 3D group showed shorter operative times (median 100 vs 119 min) and reduced fluoroscopy use (98 vs 100 s), though not statistically significant. The 3D models influenced surgical strategy in most cases, particularly in reduction planning and implant selection. No differences in complication rates or functional outcomes were observed. At 12 months, both groups achieved excellent recovery with similar KOOS, EQ-5D, WOMAC, and Rasmussen scores. CONCLUSION: 3D-printed models offer a safe and reproducible planning tool that may improve operative efficiency in tibial plateau fractures. Although functional outcomes were equivalent, there were non-significant trends suggesting a potential benefit that requires confirmation in larger, adequately powered studies. Trial registration ClinicalTrials.gov Identifier NCT05571449, registered on 1 October 2022. LEVEL OF EVIDENCE: I.