中文摘要：

目的通过比较不同方法指导人工全膝关节置换术对手术精确性及临床疗效的影响，探讨数字化设计及3D打印技术在人工全膝关节置换术中应用的可行性、优越性。方法80例（90膝）行初次人工全膝关节置换术患者被随机分为数字化组（数字化设计及3D打印组）和传统组。数字化组40例（46膝），应用数字化设计及3D打印技术指导手术；传统组40例（44膝），按传统经验进行手术。分别记录两组切口长度、手术时间、术中出血量，观察术中假体与术前设计的匹配度，评价术后患者膝关节功能活动情况，复查影像学比较术后下肢力线变化。术后3个月、6个月分别随访对比观察疼痛视觉模拟评分（VAS）、美国膝关节协会评定标准评分（KSS）和髌股关节Feller评分。结果数字化组在切口长度、手术时间、术中出血量方面较传统组有优势，假体匹配度、关节活动度、下肢力线纠正和VAS、KSS、Feller评分方面与传统组相比差异有统计学意义（P〈0．05）。结论数字化设计及3D打印技术能良好指导初次人工全膝关节置换术，有助于提高手术精确性及短期的临床疗效。

英文摘要：

Objective To explore the feasibility and superiority of digital design and 3D printing technology accuracy and clinical efficacy of surgery. Methods 80 cases （90 Knees） of patients undergoing primary total knee arthroplasty were randomly divided into ditital group （digital design and 3D printing group） and traditional group. 40 （46 knees） cases were divided into digital group and applied of digital design and 3D printing technology to guide surgery. 40 （44 knees） cases were divided into traditional group and operated by by traditional experience. Incision length, operation time, the amount of bleeding during operation of the two groups were recorded. The matching degree between the prosthesis and the preoperative design was observed. Functional activity of knee joint after operation was evaluated. The changes of the lower limb force line after the imaging examination was compared. Pain visual analogue scale （VAS）, American Knee Society rating criteria score （KSS） and patellofemoral joint Feller score at 3 months and 6 months after operation were respectively followed up and compared. Results Compared with the traditional group, the length of incision, operation time and blood loss of digital group were better than those of traditional group. There were statistical significances on prosthesis matching degree, joint mobility, lower limb force line correction and VAS, KSS, Feller score （P 〈 0.05）. Conclusion Digital design and 3D printing technology can well guide the initial total knee replacement. It is benefit to improve the accuracy and short-term clinical efficacy of surgery.