生物型髋关节假体位置参数与患者生命质量相关性研究

doi:10.3877/cma.j.issn.1674-134X.2018.04.003

目的

分析初次生物型全髋关节置换术(THA)后假体位置重建情况，探讨假体位置参数与患者生命质量的相关性，总结假体位相参数的安全范围。

方法

对南京市六合区人民医院骨科2013年3月至2015年3月52例因股骨颈骨折行初次生物型全髋关节置换术的患者进行2年的前瞻性研究。术后第3天未负重前首次拍摄患侧髋关节正侧位及骨盆正位X线片，分析髋臼及股骨柄假体的位置参数，包括髋臼外展角、髋臼前倾角、股骨头旋转中心、股骨垂直偏距、股骨偏心距、外展肌力臂、重力力臂、股骨柄内外翻、颈干角。术前和术后24个月对患者进行评估健康相关生命质量的SF-36简明健康状况调查量表(SF-36)评分。采用SPSS 17.0软件对量表进行Cronbach's (系数同质性分析、Pearson相关分析、因子分析及t检验以评价其信效度，并评价假体位置参数与SF-36各项评分提高值之间的相关性。

结果

52名患者(52髋)均完成了随访，根据THA术后首次X线片获取假体位置参数。除情感职能外，手术前后的SF-36量表内部一致性显示Cronbach's α系数>0.7；重测信度显示相关系数(CC)ICC>0.8；分半信度显示Pearson相关系数>0.874；反应度显示SF-36量表能较好地反应THA患者手术前后的生命质量变化状况；结构效应单因子分析结果示全部36个条目在各自维度上的因子载荷为0.23～0.87(P<0.05)，其中3个条目的载荷小于0.30。多因子分析结果χ²/df＝3.16，拟合优度指数(GFI)＝0.892，近似误差均方根(RMSEA)＝0.089，表明SF-36的各拟舍指数均在可被接受水平；证明SF-36的内部结构与其理论架构有很高的一致性。假体位置参数与SF-36各维度的相关系数都为正数，除GH外SF-36各维度与髋臼假体位相参数间相关系数均大于0.6，SF-36各维度与髋关节旋转中心体位相参数间高度相关，SF-36中活力(VT)、社会功能(SF)、情感职能(RE)及精神健康(MH)与股骨垂直偏距间相关系数大于0.7，SF-36中各维度与两侧股骨偏心距比例参数间相关系数均大于0.7，SF-36中SF、MH与外展肌力臂及重力力臂相参数间相关系数大于0.8，余者均大于0.7，SF-36各维度与股骨柄假体位相参数间相关系数在0.329～0.757之间，SF-36中生理功能(PF)、生理职能(RP)、社会功能(SF)与颈干角位相参数间相关系数在大于0.7。

结论

SF-36量表信度、效度均较好，可用以评估THA患者生命质量。股骨颈骨折患者的生命质量在各个领域均明显低于正常人，THA术后均得到改善。SF-36各维度可全面反映患者心理、生理及社会生活状态下的生命质量。通过对假体位相参数与SF-36各维度间的相关系数分析认为：髋臼外展角及前倾角的适当范围分别为(45±5)°、(15±5)°；颈干角应控制在(125±10)°内；髋臼假体应置于髋臼解剖位置上，以健侧为参照重建旋转中心；术后患侧肢体长度较健侧缩短不宜超过10 mm；避免减小股骨偏心距、外展肌及重力力臂；尽量保持股骨柄中立位。

关键词: 生物假体, 关节成形术，置换，髋, 生活质量

Objective

To analyze the conditions of hip prosthesis reconstruction and to probe into the relationship of the life quality and the safe range of the prosthesis position parameters.

Methods

Based on a prospective study design, from March 2013 to March 2015, 52 eligible patients (52 hips) who had had total hip arthroplasty were interviewed and measured by the short form 36-item health survey (SF-36) before and two years after the operation. The anteroposterior pelvis, anteroposterior and lateral hip joint X-rays were taken at the third day after the operation to analyze the prosthesis position parameters of acetabulum and the femoral prosthesis, including acetabulum abducent and anteversion angles, femoral head rotation center position, femoral eccentricity, femoral vertical setover, length of abductor and gravity lever arm, femoral prosthesis varus and valgus, neck shaft angle. SF-36 was used to evaluate the patient′s quality of life before and two years after the operation. SPSS 17.0 was applied to analyze the reliability and validity of SF-36 and evaluate the relationship between quality of life and prosthesis position parameters after cementless total hip arthroplasty by Pearson analysis and t test.

Results

All the patients (52 hips) completed the follow-up, and prosthesis position parameters were obtained from X-ray after THA. Except role emotional (RE), the internal consistency of before and after opration of SF-36 determined by Cronbach's alpha coefficient were greater than 0.7. Test-retest reliability of SF-36 expressed by intraclass corre-lation coefficient(ICC) were greater than 0.80. The half-split reliability expressed by Pearson correlation coefficient(CC) was greater than 0.874. The validity was good at showing the life quality changes of patients before and after the surgery. Except vitality(VT), content validity evaluated by Pearson CC were higher than 0.7 between most dimensions and items of SF-36. CC between the prosthesis position parameters and the items of SF-36 were positive value. Except general health(GH), CC between the items of SF-36 and acetabulum prosthesis position parameters were greater than 0.6, and highly relevant between the items of SF-36 and femoral head rotation center position; CC were greater than 0.7 between femoral vertical setvover and VT, social function(SF), RE and mental healt(MH), the same to femoral eccentricity; CC were larger than 0.8 between length of abductor and gravity lever arm and SF and MH, the left data were greater than 0.7; CC between femoral prosthesis and items of SF-36 ranged from 0.329 to 0.757; CC between the items of SF-36 and neck shaft angle were greater than 0.7.

Conclusions

SF-36 has good reliability and validity so that they can be used to evaluate the quality of life for THA patient. The life quality of patients with femoral neck fracture is lower than normal, while it can get much better after the operation. SF-36 can reflect the patient's psychological, physiological and social life of quality of life. The suitable range of acetabulum abducent and anteversion angles are (45±5)° and (15±5)°. The neck shaft angle should be kept in (125±10)°. Acetabulum prosthesis should be placed in the acetabulum anatomy, and the contralateral normal side as reference to rebuild femoral head rotation center position. The length of the operated hip joint is shorter than the contralateral side, which should not be more than 10 mm. Shortening of femoral eccentricity, length of abductor and gravity lever arm should be avoided, and femoral prosthesis shall be kept at neutral position.

Key words: Bioprosthesis, Arthroplasty, replacement, hip, Quality of life

表1 髋关节假体位相参数[n＝52，(±s)]

假体位置	平均参数
髋臼外展角(°)	43.7±5.3
髋臼前倾角(°)	16.1±4.5
旋转中心(°)	?
水平距离比值(%)	91.7±10.5
垂直距离比值(%)	117.5±37.8
股骨垂直偏距比值(%)	89.3±16.2
股骨偏心距比值(%)	104.6±18.6
外展肌力臂比值(%)	95.4±6.4
重力力臂比值(%)	96.7±8.7
股骨柄内、外翻(°)	2.6±1.1
颈干角(°)	126.4±10.3

表1 髋关节假体位相参数[n＝52，(±s)]

假体位置	平均参数
髋臼外展角(°)	43.7±5.3
髋臼前倾角(°)	16.1±4.5
旋转中心(°)	?
水平距离比值(%)	91.7±10.5
垂直距离比值(%)	117.5±37.8
股骨垂直偏距比值(%)	89.3±16.2
股骨偏心距比值(%)	104.6±18.6
外展肌力臂比值(%)	95.4±6.4
重力力臂比值(%)	96.7±8.7
股骨柄内、外翻(°)	2.6±1.1
颈干角(°)	126.4±10.3

表2 THA患者SF-36量表各维度间、各维度与总量表间相关性系数r值及Cronbach's α系数(n＝52)

?	PF	RP	BP	GH	VT	SF	RE	MH
PF	1.000	0.650	0.696	0.617	0.620	0.610	0.661	0.682
RP	－	1.000	0.691	0.632	0.507	0.493	0.562	0.584
BP	－	－	1.000	0.650	0.555	0.598	0.517	0.637
GH	－	－	－	1.000	0.686	0.555	0.519	0.638
VT	－	－	－	－	1.000	0.502	0.379	0.557
SF	－	－	－	－	－	1.000	0.534	0.639
RE	－	－	－	－	－	－	1.000	0.539
MH	－	－	－	－	－	－	－	1.000
共计	0.706	0.744	0.721	0.746	0.463	0.718	0.745	0.733
Cronbach's α系数	0.758	0.679	0.743	0.736	0.692	0.771	0.686	0.847

表2 THA患者SF-36量表各维度间、各维度与总量表间相关性系数r值及Cronbach's α系数(n＝52)

?	PF	RP	BP	GH	VT	SF	RE	MH
PF	1.000	0.650	0.696	0.617	0.620	0.610	0.661	0.682
RP	－	1.000	0.691	0.632	0.507	0.493	0.562	0.584
BP	－	－	1.000	0.650	0.555	0.598	0.517	0.637
GH	－	－	－	1.000	0.686	0.555	0.519	0.638
VT	－	－	－	－	1.000	0.502	0.379	0.557
SF	－	－	－	－	－	1.000	0.534	0.639
RE	－	－	－	－	－	－	1.000	0.539
MH	－	－	－	－	－	－	－	1.000
共计	0.706	0.744	0.721	0.746	0.463	0.718	0.745	0.733
Cronbach's α系数	0.758	0.679	0.743	0.736	0.692	0.771	0.686	0.847

表3 SF-36量表各维度及总量表的ICC(n＝13)

维度	ICC	95%可信区间	P值
PF	0.835	(0.659，0.967)	<0.01
RP	0.819	(0.657，0.981)	<0.01
BP	0.874	(0.820，0.903)	<0.01
GH	0.899	(0.871，0.925)	<0.01
VT	0.823	(0.754，0.912)	<0.01
SF	0.859	(0.768，0.917)	<0.01
RE	0.902	(0.795，0.924)	<0.01
MH	0.827	(0.699，0.908)	<0.01
总分	0.817	(0.689，0.854)	<0.01

表3 SF-36量表各维度及总量表的ICC(n＝13)

维度	ICC	95%可信区间	P值
PF	0.835	(0.659，0.967)	<0.01
RP	0.819	(0.657，0.981)	<0.01
BP	0.874	(0.820，0.903)	<0.01
GH	0.899	(0.871，0.925)	<0.01
VT	0.823	(0.754，0.912)	<0.01
SF	0.859	(0.768，0.917)	<0.01
RE	0.902	(0.795，0.924)	<0.01
MH	0.827	(0.699，0.908)	<0.01
总分	0.817	(0.689，0.854)	<0.01

表4 THA前后的SF-36评分[n＝52，(±s)]

?	PF	RP	BP	GH	VT	SF	RE	MH
术前	30±13	13±9	31±13	50±14	47±17	51±16	36±27	60±12
术后	56±8	40±17	63±13	62±10	58±15	62±15	67±25	71±10
提高率(%)	89.8	197.1	107.5	22.7	23.3	21.9	88.8	17.7
t值	2.20	－3.40	3.26	－4.72	－3.5	3.74	1.81	2.35
P值	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01

表4 THA前后的SF-36评分[n＝52，(±s)]

?	PF	RP	BP	GH	VT	SF	RE	MH
术前	30±13	13±9	31±13	50±14	47±17	51±16	36±27	60±12
术后	56±8	40±17	63±13	62±10	58±15	62±15	67±25	71±10
提高率(%)	89.8	197.1	107.5	22.7	23.3	21.9	88.8	17.7
t值	2.20	－3.40	3.26	－4.72	－3.5	3.74	1.81	2.35
P值	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01	<0.01

表5 单因子分析整体度量模型拟合优度(n＝52)

?	PF	RP	BP	GH	VT	SF	RE	MH
χ²/df	2.052	2.471	1.316	1.698	1.902	1.503	1.536	1.724
RMSEA	0.039	0.041	0.047	0.052	0.033	0.055	0.041	0.054
GFI	0.972	0.981	0.937	0.942	0.965	0.968	0.949	0.957
SRMR	0.095	0.094	0.079	0.089	0.092	0.087	0.095	0.093

表5 单因子分析整体度量模型拟合优度(n＝52)

?	PF	RP	BP	GH	VT	SF	RE	MH
χ²/df	2.052	2.471	1.316	1.698	1.902	1.503	1.536	1.724
RMSEA	0.039	0.041	0.047	0.052	0.033	0.055	0.041	0.054
GFI	0.972	0.981	0.937	0.942	0.965	0.968	0.949	0.957
SRMR	0.095	0.094	0.079	0.089	0.092	0.087	0.095	0.093

表6 假体位置参数与SF-36各项评分之间的相关性系数r值(n＝52)

位置参数	PF	RP	BP	GH	VT	SF	RE	MH
髋臼外展角	0.715	0.755	0.728	0.317^*	0.739	0.714	0.661	0.713
髋臼前倾角	0.786	0.709	0.731	0.389^*	0.718	0.623	0.612	0.701
旋转中心水平距离	0.740	0.728	0.768	0.507^*	0.737	0.602	0.719	0.757
旋转中心垂直距离	0.735	0.741	0.733	0.482^*	0.708	0.687	0.645	0.724
股骨垂直偏距	0.671	0.539^*	0.488^*	0.597^*	0.739	0.712	0.754	0.738
股骨偏心距	0.858	0.797	0.709	0.703	0.745	0.739	0.751	0.762
外展肌力臂	0.727	0.709	0.718	0.733	0.737	0.850	0.791	0.846
重力力臂	0.731	0.786	0.725	0.719	0.798	0.816	0.706	0.827
股骨柄内、外翻	0.734	0.652	0.757	0.329^*	0.541^*	0.489^*	0.708	0.726
颈干角	0.750	0.771	0.496^*	0.486^*	0.607	0.681	0.624	0.633

表6 假体位置参数与SF-36各项评分之间的相关性系数r值(n＝52)

位置参数	PF	RP	BP	GH	VT	SF	RE	MH
髋臼外展角	0.715	0.755	0.728	0.317^*	0.739	0.714	0.661	0.713
髋臼前倾角	0.786	0.709	0.731	0.389^*	0.718	0.623	0.612	0.701
旋转中心水平距离	0.740	0.728	0.768	0.507^*	0.737	0.602	0.719	0.757
旋转中心垂直距离	0.735	0.741	0.733	0.482^*	0.708	0.687	0.645	0.724
股骨垂直偏距	0.671	0.539^*	0.488^*	0.597^*	0.739	0.712	0.754	0.738
股骨偏心距	0.858	0.797	0.709	0.703	0.745	0.739	0.751	0.762
外展肌力臂	0.727	0.709	0.718	0.733	0.737	0.850	0.791	0.846
重力力臂	0.731	0.786	0.725	0.719	0.798	0.816	0.706	0.827
股骨柄内、外翻	0.734	0.652	0.757	0.329^*	0.541^*	0.489^*	0.708	0.726
颈干角	0.750	0.771	0.496^*	0.486^*	0.607	0.681	0.624	0.633

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Relationship between life quality and prosthesis position parameters after cementless total hip arthroplasty

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Relationship between life quality and prosthesis position parameters after cementless total hip arthroplasty