Clinical Efficacy of Patient-Specific 3D-Printed Surgical Guides in Orthopedic Reconstruction: A Prospective Cohort Study Evaluating Surgical Accuracy, Operative Efficiency, and Functional Recovery

Abstract

Accurate implant positioning and anatomical reconstruction are critical determinants of successful orthopedic surgery, yet conventional freehand techniques guided by intraoperative fluoroscopy remain susceptible to variability in surgical precision, prolonged operative time, and inconsistent postoperative outcomes. Patient-specific three-dimensional (3D)-printed surgical guides have emerged as a promising precision medicine technology capable of translating preoperative virtual planning directly into surgical execution, although prospective clinical evidence supporting their effectiveness remains limited. This prospective cohort study evaluated whether patient-specific 3D-printed surgical guides improve surgical accuracy, operative efficiency, and functional recovery compared with conventional surgical techniques in patients undergoing complex orthopedic reconstruction. A total of 101 patients treated at a tertiary academic referral center between January 2024 and March 2026 were enrolled, including 50 patients who underwent CT-based virtual surgical planning followed by fabrication of patient-specific polyamide-12 surgical guides using selective laser sintering and 51 patients who received conventional freehand surgery with intraoperative fluoroscopic guidance. Primary outcomes included surgical accuracy, assessed by the deviation between planned and achieved correction angles and implant positioning measured on postoperative computed tomography. Secondary outcomes included operative time, intraoperative blood loss, fluoroscopy exposure, length of hospital stay, and postoperative functional recovery evaluated using the Harris Hip Score (HHS), Knee Society Score (KSS), Short Form-36 (SF-36), and Visual Analog Scale (VAS) pain score at 3, 6, and 12 months. The patient-specific 3D-printed guide group demonstrated significantly greater surgical precision, with a mean correction angle deviation of 1.2° ± 0.4° compared with 3.8° ± 1.1° in the conventional group (p < 0.001) and a mean implant position deviation of 1.2 ± 0.5 mm versus 3.8 ± 1.4 mm (p < 0.001). The use of patient-specific guides also significantly reduced operative time (94.3 ± 18.7 vs. 138.6 ± 25.4 minutes; p < 0.001), intraoperative blood loss (215 ± 68 vs. 345 ± 92 mL; p < 0.001), and fluoroscopy exposure (28.5 ± 8.2 vs. 67.2 ± 14.8 seconds; p < 0.001). At 12 months, patients treated with patient-specific guides achieved significantly better functional outcomes, including higher Harris Hip Scores (89.7 ± 6.2 vs. 78.3 ± 8.1; p < 0.001) and lower VAS pain scores (0.9 ± 0.6 vs. 1.8 ± 0.9; p < 0.001), while complication rates remained comparable between groups (12.0% vs. 15.7%; p = 0.59). These findings demonstrate that patient-specific 3D-printed surgical guides substantially enhance surgical precision and operative efficiency while improving postoperative functional recovery without increasing complications in complex orthopedic reconstruction. The results support the integration of patient-specific 3D-printed guides into precision orthopedic surgery, although larger multicenter randomized clinical trials with long-term follow-up are needed to confirm implant survivorship, cost-effectiveness, and broader clinical applicability