国产股骨柄假体在前路髋关节置换中的应用

doi:10.3877/cma.j.issn.1674-134X.2021.02.018

目的

评价BE2柄在植入后早期的稳定性(下沉、偏移)、并发症及功能评分的结果，以及初步评价BE2股骨柄假体植入后早期的临床效果。

方法

收集2018年9月至2019年12月于哈医大一院骨科采用BE2股骨柄假体进行初次髋关节置换术的病例资料，全部病例均为微创前路关节置换(DAMIS)。本组包括89例(110髋)，男50例(65髋)，女39例(45髋)其中股骨头坏死62例(74髋)，股骨颈骨折8例，髋关节骨关节炎6例(8髋)，DDH6例(9髋)，强直髋7例(11髋)。随访内容包括术中阔筋膜张肌肌肉损伤量，术前术后标准骨盆正位片、髋关节功能评分(Harris评分)、牛津髋关节评分(OHS)及髋关节伤残及骨关节炎-身体机能(HOOS-PS)评分、健康调查简表(SF-36量表)、疼痛视觉模拟评分(VAS)，并采用重复测量方差分析评分数据。

结果

术中测量损伤的阔筋膜张肌肌肉的质量(0.51±0.31)g。Harris评分(F＝687.77, P<0.001)，OHS评分(F＝215.98, P<0.001)，HOOS-PS评分(F＝499.48, P<0.001)，VAS评分(F＝1066.53, P<0.001)，以及SF-36量表中心理健康评分(PCS评分)(F＝551.61, P<0.001)，身体健康评分(MCS评分)(F＝207.55, P<0.001)，术后末次随访较术前比较差异均具有统计学意义。影像学测量显示，2名患者术后3个月可见股骨柄下沉超过3 mm、2名患者术后6个月可见股骨柄轴向偏移超过3°。双侧置换者术后双侧偏心距差别均小于4 mm，术后3个月时影像学上可见假体表面骨长上迹象。

结论

国产BE2型股骨柄假体应用在不同骨质量的髋关节置换中，能获得早期的干骺端骨结合和可靠的假体早期稳定性，可以良好地重建股骨近端偏心距，有效地改善髋关节活动功能。术后早期并发症发生率低。尤其适合于应用于DAMIS中。

关键词: 关节成形术, 置换, 髋, 外科手术, 微创性, 假体和植入物

Objective

To evaluate the stability (subsidence, deviation), complications and functional scores of the BE2 femoral stem prosthesis, and to evaluate the early clinical effect of BE2 femoral stem prosthesis.

Methods

The clinical data with the use of BE2 femoral stem in the orthopaedics department of the 1st Affiliated Hospital of Harbin Medical University from Sept 2018 to Dec 2019. There were 89 cases (110 hips), including 50 males (65 hips) and 39 females (45 hips). The main pathology for surgery included osteonecrosis of the femoral head (62 cases, 74 hips), femoral neck fracture(eight cases), hip osteoarthritis(six cases, eight hips), DDH(developmental dysplasia of the hip) (six cases, nine hips) and ankylosis (seven cases, 11 hips) . The contents of follow-up included intraoperative measurement of muscle injury of tensor fascia lata, preoperative and postoperative standard pelvic radiograph, Harris score, Oxford hip score(OHS), hip disability and osteoarthritis outcome score-performance status(HOOS-PS), short form 36-item (SF- 36)scale, and visual analogue scale(VAS) score. Repeated measurement of variarance wasapplied for data analysis.

Results

The average amount of debried tensor fascia lata muscle was(0.51±0.31)g. There were significant differences between postoperative and the last preoperative follow-up, including Harris score (F=687.77, P<0.001), OHS score(F=215.98, P<0.001), HOOS-PS(F=499.48, P<0.001), VAS score(F=1066.53, P<0.001), and physical component summary (PCS)score of SF-36 scale(F=551.61, P<0.001) mental component summary(MCS) score of SF-36 scale(F=207.55, P<0.001). The results of radiographic measurement showed that two patients had stem subsidence three months, two patients had axial stem deviation six months. In the patients with bilateral replacement, the difference of bilateral offset distance was less than 4 mm, and signs of bone ingrowth began to appear on the surface of prosthesis in three months after operation.

Conclusions

The early outcomes of the BE2 stem applied consecutively in the patient with different bone stock are promising. Solid stability can be obtained within three months by metaphysical bone integration, leading to fast restoration of the hip function. Furthermore, BE2 is more suitable in DAMIS.

Key words: Arthroplasty, Replacement, Hip, Minimally Invasive Surgery, Prostheses and implants

图2 随访病例各疾病数量

表1 BE2型股骨柄假体手术前后临床评分比较分析(分，n＝89)

时间	Harris	OHS	HOOS-PS	SF-36		VAS
时间	Harris	OHS	HOOS-PS	PCS	MCS	VAS
术前	40.6±18.9	38.7±8.9	67.4±13.7	29.0±9.7	50.9±9.6	6.6±1.2
术后3个月	84.0±3.9	29.7±2.8	44.0±5.5	48.6±6.9	66.6±6.9	2.1±0.8
术后6个月	96.2±3.7	22.4±2.9	28.2±5.3	65.0±6.3	72.1±6.4	0.6±0.2
F值^a	443.2	80.0	205.7	238.1	156.9	1 476.5
F值^b	687.8	216.0	499.45	551.6	207.6	1 066.5
F值^c	485.0	186.9	233.0	171.8	18.2	119.7
P值	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001

表1 BE2型股骨柄假体手术前后临床评分比较分析(分，n＝89)

时间	Harris	OHS	HOOS-PS	SF-36		VAS
时间	Harris	OHS	HOOS-PS	PCS	MCS	VAS
术前	40.6±18.9	38.7±8.9	67.4±13.7	29.0±9.7	50.9±9.6	6.6±1.2
术后3个月	84.0±3.9	29.7±2.8	44.0±5.5	48.6±6.9	66.6±6.9	2.1±0.8
术后6个月	96.2±3.7	22.4±2.9	28.2±5.3	65.0±6.3	72.1±6.4	0.6±0.2
F值^a	443.2	80.0	205.7	238.1	156.9	1 476.5
F值^b	687.8	216.0	499.45	551.6	207.6	1 066.5
F值^c	485.0	186.9	233.0	171.8	18.2	119.7
P值	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001

图3 BE2型股骨柄假体手术前后临床评分变化趋势。图A为Harris髋关节评分，示上升趋势；图B为HOOS(髋关节伤残及骨关节炎评分)评分，示下降趋势；图C为OHS(牛津髋关节评分)评分，示下降趋势；图D为MSC(心理健康)评分，示上升趋势；图E为PCS(身体健康)评分，示上升趋势；图F为VAS(视觉模拟评分)评分，示下降趋势

图5 髋关节置换手术前后偏心距重建情况影像。图A全髋关节置换术前骨盆正位片，示右髋关节骨关节炎；图B全髋关节置换术后随访骨盆正位片，示髋关节偏心距重建情况良好

图6 髋关节置换术后骨界面愈合情况影像。图A全髋关节置换术后即时骨盆正位片，示假体位置良好；图B全髋关节置换术后3个月骨盆正位片，示BE2柄与骨界面愈合良好

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摘要

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Application of domestic femoral stem prosthesis in direct anterior arthroplasty

模态框（Modal）标题

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Application of domestic femoral stem prosthesis in direct anterior arthroplasty