在全膝关节置换术中评估计算机辅助手术和定制器械与传统器械相比的临床结果：一项随机对照试验。
Evaluating the clinical outcomes of computer-assisted surgery and patient-specific instrumentation compared to conventional instrumentation in total knee arthroplasty, a randomised controlled trial.
作者信息
Dong Ziyang, Li Yang, Zhang Yipu, Geng Xiao, Wang Xinguang, Zheng Yuhang, Feng Junhao, Han Zhencan, Tian Hua
机构信息
Department of Orthopaedics, Peking University Third Hospital, Beijing, China.
Engineering Research Center of Bone and Joint Precision Medicine, Ministry of Education, Beijing, China.
出版信息
BMC Musculoskelet Disord. 2025 Aug 14;26(1):785. doi: 10.1186/s12891-025-08980-7.
OBJECTIVE
Computer-assisted surgery (CAS) and patient-specific instrumentation (PSI) are digital techniques to improve the accuracy of implant positioning in total knee arthroplasty (TKA), but their effects on clinical outcomes are still in dispute. The objective of this trial is to evaluate the efficacy and safety of CAS and PSI compared to conventional instrumentation (CI) in TKA.
METHODS
A prospective randomized controlled trial was conducted. A total of 135 patients undergoing TKA were randomized into CAS group, PSI group and CI group with 45 patients in each group. Primary outcome is the coronal mechanical axis of lower extremity. Secondary outcomes include Femoral Rotation Angle (FRA) of the femoral prosthesis, operation time, perioperative blood loss, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS) and complications.
RESULTS
Outliers of Hip-Knee-Ankle angle (HKA) were 24.4% in CI group, 17.8% in CAS group and 31.1% in PSI group respectively, and there was no significant difference among these 3 groups (P > 0.05). Outliers of FRA were 13.3% in CI group, 26.7% in CAS group and 11.1% in PSI group respectively with no significant difference (P > 0.05). Operation time was (66.67 ± 12.85)min, (81.67 ± 12.31)min and (52.78 ± 8.62)min in CI, CAS and PSI group. Operation time in CI was longer than PSI and shorter than CAS with significant difference (P < 0.01). There was no significant difference in comparison of blood loss, transfusion rate, postoperative WOMAC and FJS (P > 0.05).
CONCLUSION
CAS and PSI, compared with CI, did not significantly improve clinical outcomes including lower limb alignment, rotation of femoral prosthesis, blood loss, transfusion rate, and function scores. However, CAS was associated with prolonged operation time, whereas PSI resulted in a reduced operation time.
LEVEL OF EVIDENCE
Level II.
TRIAL REGISTRATION
ChiCTR-INR-17,012,881 (registration date: 03/10/2017).
目的
计算机辅助手术（CAS）和患者特异性器械（PSI）是提高全膝关节置换术（TKA）中植入物定位准确性的数字技术，但它们对临床结果的影响仍存在争议。本试验的目的是评估CAS和PSI与传统器械（CI）相比在TKA中的有效性和安全性。
方法
进行一项前瞻性随机对照试验。总共135例行TKA的患者被随机分为CAS组、PSI组和CI组，每组45例。主要结局是下肢的冠状面机械轴。次要结局包括股骨假体的股骨旋转角度（FRA）、手术时间、围手术期失血量、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、遗忘关节评分（FJS）和并发症。
结果
CI组、CAS组和PSI组的髋-膝-踝角（HKA）异常值分别为24.4%、17.8%和31.1%，这三组之间无显著差异（P>0.05）。FRA异常值在CI组为13.3%，在CAS组为26.7%，在PSI组为11.1%，差异无统计学意义（P>0.05）。CI组、CAS组和PSI组的手术时间分别为（66.67±12.85）分钟、（81.67±12.31）分钟和（52.78±8.62）分钟。CI组的手术时间长于PSI组且短于CAS组，差异有统计学意义（P<0.01）。在失血量、输血率、术后WOMAC和FJS的比较中无显著差异（P>0.05）。
结论
与CI相比，CAS和PSI在改善包括下肢对线、股骨假体旋转、失血量、输血率和功能评分等临床结局方面没有显著效果。然而，CAS与手术时间延长有关，而PSI则缩短了手术时间。
证据级别
二级。
试验注册
中国临床试验注册中心注册号ChiCTR-INR-17,012,881（注册日期：2017年10月3日）。
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