中华骨与关节外科杂志

2025, 01, v.18 11-18

机器人辅助下功能性对线与机械轴对线全膝关节置换术的早期临床疗效：一项前瞻性双盲随机对照试验

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邮箱(Email): dr_zhangxianlong@sjtu.edu.cn;

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摘要：

目的：比较机器人辅助下功能性对线（FA）与机械轴对线（MA）全膝关节置换术（TKA）的早期临床疗效。方法：前瞻性纳入2021年9月至2022年3月上海交通大学医学院附属第六人民医院收治的拟行TKA治疗的100例膝骨关节炎（KOA）患者。采用随机数字表法进行分组，采用FA的50例患者作为FA-TKA组，采用MA的50例作为MA-TKA组。比较两组患者的术中指标，包括下肢力线、间隙平衡、软组织松解和手术时间；评估术后6个月的临床疗效，包括患者满意度Likert评分、疼痛视觉模拟评分（VAS）、膝关节活动度（ROM）、膝关节损伤和骨关节炎结果评分（KOOS）、2011年美国膝关节协会评分（2011 KSS）和关节遗忘评分（FJS）。结果：100例患者中1例失随访，其余患者均获得6个月以上随访，最终FA-TKA组50例和MA-TKA组49例纳入研究。与MA-TKA组相比，FA-TKA组患者明显减少了软组织松解次数、松解范围，缩短了手术时间（P均<0.05）；术后6个月KOOS-疼痛、KOOS-日常生活、KOOS-生活质量和FJS均有显著提高（P均<0.05），爬楼时的疼痛VAS评分明显降低（P<0.05）。结论：TKA中采用FA可减少软组织松解，缩短手术时间，减轻术后疼痛，患者的早期临床预后良好。

关键词： 全膝关节置换术; 机器人; 个性化对线; 功能性对线; 机械轴对线;

Abstract：

Objective: To compare the early clinical efficacy of robot-assisted functional alignment(FA) versus mechanical alignment(MA) in total knee arthroplasty(TKA). Methods: A prospective study was conducted on 100 patients with knee osteoarthritis(KOA)scheduled for TKA at the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from September 2021 to March 2022. Patients were randomly assigned to two groups using a random numbers table: 50 patients underwent FA(FA-TKA group) and 50 patients underwent MA(MA-TKA group). Intraoperative indicators, including lower limb alignment, gap balance, soft tissue release, and surgical time, were compared between the two groups. Postoperative clinical efficacy at 6 months were assessed,including Likert scale satisfaction scores, visual analogue scale(VAS) for pain, knee range of motion(ROM), knee injury and osteoarthritis outcome score(KOOS), 2011 Knee Society score(2011 KSS), and Forgotten Joint Score(FJS). Results: Out of 100 patients, 1 was lost to follow-up, while the remaining patients were followed up for more than 6 months. Ultimately, 50 patients in the FA-TKA group and 49 patients in the MA-TKA group were included in the study. Compared to the MA-TKA group, the FA-TKA group demonstrated a significant reduction in both the frequency and extent of soft tissue release, as well as a shorter surgical time(all P<0.05).At 6 months postoperatively, the FA-TKA group showed significant improvements in KOOS-pain, KOOS-daily living, KOOS-quality of life, and FJS(all P<0.05). Additionally, the VAS score for pain during stair climbing was significantly lower(P<0.05). Conclusions:The use of FA in TKA can reduce soft tissue release, shorten surgical time, and alleviate postoperative pain, and leading to a favorable early clinical prognosis for patients.

KeyWords： Total Knee Arthroplasty; Robot; Personalized Alignment; Functional Alignment; Mechanical Alignment;

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中图分类号:R687.4

引用信息:

[1]王俏杰,闫自晓,王琦等.机器人辅助下功能性对线与机械轴对线全膝关节置换术的早期临床疗效：一项前瞻性双盲随机对照试验[J].中华骨与关节外科杂志,2025,18(01):11-18.

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中华骨与关节外科杂志

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