便携式导航辅助全膝关节置换术力线校准的Meta分析

doi:10.3877/cma.j.issn.1674-134X.2019.01.016

目的

应用Meta分析的方法评价便携式导航辅助全膝关节置换术(TKA)与常规人工TKA对术后下肢机械轴线和假体力线的影响。

方法

检索Cochrane图书馆、PubMed、EMbase、Web of Science、中国期刊全文数据库、维普咨迅数据库及万方数据库等数据库，根据纳入标准(测量了下肢力线的便携式导航辅助和常规初次TKA临床研究)和排除标准(膝关节内外翻畸形大于15°、术侧髋关节异常)，收集所有相关的随机对照试验和非随机对照试验，检索截止日期为2018年5月，由两名评价员独立筛查文献、提取资料和方法学质量评估，采用Cochrane协作网提供的软件Rev Man 5.3.0软件进行Meta分析。

结果

一共纳入11篇临床文献(4篇随机对照试验，7篇非随机对照试验)，分析1 334膝，其中导航组641膝，常规组693膝。Meta分析结果显示：导航组下肢机械轴线偏离±3°离群个数少于常规组，差异有统计学意义[RR ＝0.57，95%CI(0.43，0.76)，P<0.05]，而冠状面股骨假体力线[RR ＝0.45，95%CI(0.20，1.06)，P ＝0.07]、冠状面胫骨假体力线[RR ＝0.67，95%CI(0.41，1.11)，P ＝0.12]、矢状面股骨假体力线[RR ＝1.03，95%CI(0.72，1.46)，P ＝0.89]、矢状面胫骨假体力线[RR ＝1.13，95%CI(0.62，2.07)，P ＝0.69]两组间差异均无统计学意义。

结论

便携式导航辅助TKA恢复下肢机械轴线的精准性优于常规人工TKA，但两者在恢复冠状面和矢状面假体植入位置准确性方面无差异；上述结果尚需要更多高质量、大样本及多中心随机试验来进一步验证。

关键词: 骨关节炎，膝, 关节成形术，置换，膝, 外科手术，计算机辅助, Meta分析

Objective

To conduct a meta-analysis of published studies comparing accelerometer-based navigation(ABN) and conventional instrumentation(CON) in total knee arthroplasty (TKA).

Methods

The Cochrane Library, PubMed, EMBASE, Web of Science, China National Knowledge Internet(CNKI), VIP and WanFang data bases were searched to identify randomized controlled trials (RCTs) and non-randomized controlled trials(nRCTs) articles comparing the ABN with CON in primary TKA up to May 2018; severe knee deformity and hip abnormity on the operation side were excluded. Study selection and assessment, data collection and analysis were undertaken by two authors independently. The meta-analysis was performed using Review Manager 5.3.0.

Results

Eleven studies were included, involving four RCTs and seven nRCTs. A total of 1 334 knees were compared between the navigated group (n=641) and the conventional group (n=693). Meta-analysis suggested that the outliers from mechanical axis in navigated group was less than that of conventional group[RR=0.57, 95%CI: (0.43, 0.76), P<0.05]. There was no significant difference between the two groups in coronal femoral component outliers[RR=0.45, 95%CI (0.20, 1.06), P=0.07], coronal tibial component outliers[RR=0.67, 95%CI (0.41, 1.11), P=0.12], sagittal femoral component outliers [RR=1.03, 95%CI (0.72, 1.46), P=0.89], sagittal tibial component outliers[RR=1.13, 95%CI (0.62, 2.07), P=0.69].

Conclusion

Total knee arthroplasty with hand-held, portable navigation is more accurate than conventional surgery in achieving a neutral mechanical axis, but there is no difference in coronal and sagittal implant positioning; more high-quality, large-sample, multicenter RCTs are required for further investigation.

Key words: Osteoarthritis, knee, Arthroplasty, replacement, knee, Surgery, computer-assisted, Meta analysis

图1 文献纳入和排除流程图

表1 纳入研究的一般资料

作者	研究方法	性别(男/女)		平均年龄(岁)		患膝(TKA)		导航系统	假体类型
作者	研究方法	导航	常规	导航	常规	导航	常规	导航系统	假体类型
Kinney MC^[12]	随机对照研究	12/13	9/16	66.4	65	25	25	iASSIST	PS Persona?
Ikawa T^[17]	随机对照研究	15/106	19/101	74	74.1	121	120	KneeAlign2	Vanguard RP or PS
Gharaibeh^[9]	随机对照研究	34/55	39/50	69.2	69	89	90	KneeAlign	Legion or Score
Nam D^[14]	随机对照研究	18/29	20/27	67.1	66.1	47	47	KneeAlign	不清楚
Goh GS^[8]	前瞻性队列研究	10/28	20/56	63.9	66.4	38	76	iASSIST	不清楚
Moo IH^[15]	回顾性队列研究	10/20	12/18	67	64	30	30	iASSIST	Nexgen？
Liow MH^[13]	回顾性队列研究	26/66	27/73	65	66.3	92	100	iASSIST	不清楚
Matsumoto^[10]	回顾性队列研究	46	41	74.7	73.1	50	50	KneeAlign2	Vanguard RP
Kawaguchi^[11]	回顾性队列研究	6/26	7/25	76	72.3	34	33	KneeAlign2	Vanguard PS
Ueyama H^[18]	回顾性队列研究	8/59	14/61	76.9	78.1	67	75	KneeAlign2	Vanguard PS
Fujimoto^[16]	回顾性队列研究	不清楚	不清楚	不清楚	不清楚	48	47	KneeAlign2	Vanguard CR or Persona(Zimmer)

表1 纳入研究的一般资料

作者	研究方法	性别(男/女)		平均年龄(岁)		患膝(TKA)		导航系统	假体类型
作者	研究方法	导航	常规	导航	常规	导航	常规	导航系统	假体类型
Kinney MC^[12]	随机对照研究	12/13	9/16	66.4	65	25	25	iASSIST	PS Persona?
Ikawa T^[17]	随机对照研究	15/106	19/101	74	74.1	121	120	KneeAlign2	Vanguard RP or PS
Gharaibeh^[9]	随机对照研究	34/55	39/50	69.2	69	89	90	KneeAlign	Legion or Score
Nam D^[14]	随机对照研究	18/29	20/27	67.1	66.1	47	47	KneeAlign	不清楚
Goh GS^[8]	前瞻性队列研究	10/28	20/56	63.9	66.4	38	76	iASSIST	不清楚
Moo IH^[15]	回顾性队列研究	10/20	12/18	67	64	30	30	iASSIST	Nexgen？
Liow MH^[13]	回顾性队列研究	26/66	27/73	65	66.3	92	100	iASSIST	不清楚
Matsumoto^[10]	回顾性队列研究	46	41	74.7	73.1	50	50	KneeAlign2	Vanguard RP
Kawaguchi^[11]	回顾性队列研究	6/26	7/25	76	72.3	34	33	KneeAlign2	Vanguard PS
Ueyama H^[18]	回顾性队列研究	8/59	14/61	76.9	78.1	67	75	KneeAlign2	Vanguard PS
Fujimoto^[16]	回顾性队列研究	不清楚	不清楚	不清楚	不清楚	48	47	KneeAlign2	Vanguard CR or Persona(Zimmer)

表2 纳入研究的Cochrane风险偏倚评估

作者	随机序列	隐蔽分组	受试者和实施者双盲	结局评估盲法	失访与退出	选择性报告	其他偏倚
Kinney ^[12]	A	B	A	A	A	A	A
Ikawa ^[17]	A	B	B	A	A	A	A
Gharaibeh^[9]	A	B	B	B	A	A	A
Nam ^[14]	A	A	A	A	A	A	A

表2 纳入研究的Cochrane风险偏倚评估

作者	随机序列	隐蔽分组	受试者和实施者双盲	结局评估盲法	失访与退出	选择性报告	其他偏倚
Kinney ^[12]	A	B	A	A	A	A	A
Ikawa ^[17]	A	B	B	A	A	A	A
Gharaibeh^[9]	A	B	B	B	A	A	A
Nam ^[14]	A	A	A	A	A	A	A

表3 纳入研究的NOQAS量表评分

作者	队列选择	可比性	暴露/结局	总分
Goh^[8]	4	2	3	9
Moo^[15]	4	2	2	8
Liow MH^[13]	3	2	2	7
Matsumoto^[10]	4	2	2	8
Kawaguchi^[11]	4	2	3	9
Ueyama^[18]	3	2	3	8
Fujimoto^[16]	4	1	2	7

表3 纳入研究的NOQAS量表评分

作者	队列选择	可比性	暴露/结局	总分
Goh^[8]	4	2	3	9
Moo^[15]	4	2	2	8
Liow MH^[13]	3	2	2	7
Matsumoto^[10]	4	2	2	8
Kawaguchi^[11]	4	2	3	9
Ueyama^[18]	3	2	3	8
Fujimoto^[16]	4	1	2	7

图2 导航组和常规组下肢机械轴线偏离±3°的离群个数比较

图3 导航组和常规组冠状面股骨假体力线偏离±3°的离群个数比较

图4 导航组和常规组冠状面胫骨假体力线偏离±3°的离群个数比较

图5 导航组和常规组矢状面股骨假体力线偏离±3°的离群个数比较

图6 导航组和常规组矢状面胫骨假体力线偏离±3°的离群个数比较

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Meta-analysis on alignment outcomes of total knee arthroplasty with portable navigation

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Meta-analysis on alignment outcomes of total knee arthroplasty with portable navigation