个性化股骨导向器辅助初次全髋关节置换的随机对照研究

doi:10.3877/cma.j.issn.1674-134X.2023.06.004

目的

评估一种全新的、基于CT数据个性化定制3D打印的股骨导向器辅助关节骨科青年医师行初次人工全髋关节置换术中的可行性和有效性。

方法

研究纳入了2020年3月至2020年11月期间在华中科技大学同济医学院附属协和医院骨科单独带组5年内的关节骨科医师主刀的诊断为髋关节炎、股骨头坏死(Ficat Ⅲ或Ⅳ期)、股骨颈骨折(头下型)、CroweⅠ型髋关节发育不良而接受初次单侧THA的患者。排除既往髋关节手术史，双侧髋关节疾病或者股骨近端严重畸形的患者。筛选的122例患者中有100名患者纳入本次研究，根据随机数表法分为常规术前计划组50例(常规组)和股骨导向器组50例(导向器组)。比较两组患者的手术时间、术中失血量、总失血量、手术后影像学数据(包括术后股骨偏心距差异、前倾角差异，双下肢长度差异)、双下肢不等长感知度、视觉疼痛模拟评分(VAS)及哈里斯髋关节评分(HHS)。同时记录了围手术期并发症的发生情况。年龄、身体质量指数、双下肢长度差异(LLD)、偏心距差异、前倾角差异、手术时间、术中失血量、总失血量使用独立样本t检验评估组间差异。

结果

两组患者的人口统计数据基本相似。导向器组术后的影像学测量结果更优，导向器组患者双下肢长度差异(1.6±1.2)mm vs(5.6±2.9)mm(t＝9.012，P<0.001)、股骨偏心距差异(3.1±1.4)mm vs(6.5±3.4)mm(t＝6.538，P<0.001)和股骨前倾角度差异(5.2±2.5)°vs(9.7±4.6)°(t＝6.078，P<0.001)均小于常规组患者，差异均有统计学意义；导向器组的VAS评分(时间效应F＝249.8，P<0.001；交互效应F＝ 0.181, P>0.05；组间效应F＝6.545，P＝0.011)、HSS评分(时间效应F＝341.1，交互效应F＝7.088，组间效应F＝68.91，均为P<0.001)均优于常规组。导向器组患者在术后第3个月(14% vs 36%，χ²＝6.453，P＝0.011)、第6个月(10% vs 26%，χ²＝4.336，P＝0.037)和第12个月(6% vs 20%，χ²＝4.336，P＝0.037)的双下肢不等长感知率也明显低于常规组患者，差异均有统计学意义。而手术时间、术中失血量、总失血量和围术期并发症发生率两组无明显差异。

结论

全新的、个性化定制3D打印股骨导向器在不增加手术时间、出血及术后并发症前提下能够显著提高关节骨科青年医师在初次人工全髋关节置换术中股骨侧假体置入的精准度及术后关节功能，利于术后患者加速康复。

关键词: 关节成形术，置换，髋, 打印，三维, 腿长不等, 手术中并发症

Objective

To evaluate the feasibility and effectiveness of a novel 3D printed femoral guide customized based on CT data to assist young orthopedic joint surgeons in performing primary total hip arthroplasty (THA).

Methods

The study included patients diagnosed with hip osteoarthritis, femoral head necrosis, femoral neck fracture, and Crowe I type hip dysplasia who underwent unilateral THA performed by young joint orthopedic surgeons at Wuhan Union Hospital, from March 2020 to November 2020. Patients with a history of hip surgery, bilateral hip diseases, or severe proximal femoral deformities were excluded. Among the 122 patients screened, 100 cases were enrolled for analysis, and were divided into the conventional preoperative planning group (Con group) and the femoral guide group (PSG group) by random number table, 50 in each group. The two groups were compared for operation time, intraoperative blood loss, total blood loss, postoperative radiological data[including lower limb discrepancy(LLD), differences of anteversion angle and femoral offset], visual analogue scale (VAS) pain score, and Harris hip score (HHS). Perioperative complications were also recorded. Age, body mass index, LLD, differences of off set and anteversion angle, operation time, intraoperative and total blood loss were analysed by independent sample t test.

Results

The demographics of the two groups were similar. The differences in LLD (1.6±1.2)mm vs(5.6±2.9)mm(t=9.012, P<0.001), femoral offset(3.1±1.4)mm vs(6.5±3.4)mm (t=6.538, P<0.001), and femoral anteversion (5.2±2.5)° vs(9.7±4.6)°(t=6.078, P<0.001) in PSG group were all smaller than those in the conventional group, and these differences were statistically significant. VAS scores(time effect F=249.8, P<0.001; interaction effect F=0.181, P>0.05; group effect F=6.545, P=0.011) and HSS scores (time effect F=341.1, P<0.001; interaction effect F=7.088, P<0.001; group effect F=68.91, P<0.001) in the PSG group were all better than the data in the conventional group. The perception rate of LLD in the PSG group was significantly lower than that in the conventional group at the third month (14% vs 36%, χ²=6.453, P=0.011), sixth month (10% vs 26%, χ²=4.336, P=0.037), and 12th month (6% vs 20%, χ²=4.336, P=0.037) after surgery, with statistically significant differences. Utilization of the PSG had no significant increase in operative time, intraoperative blood loss, total blood loss or postoperative complications.

Conclusion

The application with the PSG could potentially provide a simple and reliable solution for young orthopedic surgeons in improving femoral prosthesis orientation during THA with high accessibility and low health-care costs, which is beneficial for rapid recovery.

Key words: Arthroplasty, replacement, hip, Printing, three dimentional, Leg length inequality, Postoperative Complications

图1 研究流程图(包括入组、分组、随访和数据分析)

Figure 1 Research flow chart (including enrollment, grouping, follow-up, and data analysis)

图2 股骨PSG(手术辅助导向器)大体观及术中应用。图A和B为PSG大体观及其组件；图C为PSG术中指示股骨开口角度及股骨解剖轴方向；图D为PSG术中指示正常股骨头旋转中心位置

Figure 2 General view and intraoperative application of femur PSG. A and B are the general views and components of PSG; C is PSG showing the opening angle and anatomic axis of femur with PSG; D is PSG showing the natural femoral rotation center during surgery

表1 两组患者术前基线资料比较

Table 1 Preoperative characteristics of patients

组别Groups	例数Number of cases	年龄[岁，(±s)]Age(year)	身体质量指数[kg/m²，(±s)]Body mass index	性别(男/女)Gender(male/female)	入院诊断(例)Diagnosis
组别Groups	例数Number of cases	年龄[岁，(±s)]Age(year)	身体质量指数[kg/m²，(±s)]Body mass index	性别(男/女)Gender(male/female)	骨关节炎Osteoarthritis	股骨头坏死Femoral head necrosis	股骨颈骨折Feomoral neck fractures	髋关节发育不良Developmental dysplasia of hip
常规组Convention group	50	59±12	23±3	22/28	27	10	8	5
导向器组PSG group	50	61±14	24±3	20/30	29	11	7	3
统计值Statistical value		t＝0.752	t＝0.469	χ²＝0.164	χ²＝0.686
P值		>0.05	>0.05	>0.05	>0.05

表1 两组患者术前基线资料比较

Table 1 Preoperative characteristics of patients

组别Groups	例数Number of cases	年龄[岁，(±s)]Age(year)	身体质量指数[kg/m²，(±s)]Body mass index	性别(男/女)Gender(male/female)	入院诊断(例)Diagnosis
组别Groups	例数Number of cases	年龄[岁，(±s)]Age(year)	身体质量指数[kg/m²，(±s)]Body mass index	性别(男/女)Gender(male/female)	骨关节炎Osteoarthritis	股骨头坏死Femoral head necrosis	股骨颈骨折Feomoral neck fractures	髋关节发育不良Developmental dysplasia of hip
常规组Convention group	50	59±12	23±3	22/28	27	10	8	5
导向器组PSG group	50	61±14	24±3	20/30	29	11	7	3
统计值Statistical value		t＝0.752	t＝0.469	χ²＝0.164	χ²＝0.686
P值		>0.05	>0.05	>0.05	>0.05

表2 影像学测量数据

Table 2 Radiographic measurements

组别Groups	例数Number of cases	双下肢长度差异[mm，(±s)]LLD	LLD≤5 mm[例(%)]	偏心距差异[mm，(±s)]Difference of femoral offset	偏心距差异≤5 mm[例(%)]Femoral offset≤5 mm	前倾角差异[°，(±s)])Difference of anteversion
常规组Convention group	50	5.6±2.9	24(48.0)	6.5±3.4	32(64.0)	9.7±4.6
导向器组PSG group	50	1.6±1.2	50(100.0)	3.1±1.4	42(84.0)	5.2±2.5
统计值Statistical value		t＝9.012	χ²＝35.135	t＝6.538	χ²＝5.198	t＝6.078
P值		<0.001	<0.001	<0.001	0.023	<0.001

表2 影像学测量数据

Table 2 Radiographic measurements

组别Groups	例数Number of cases	双下肢长度差异[mm，(±s)]LLD	LLD≤5 mm[例(%)]	偏心距差异[mm，(±s)]Difference of femoral offset	偏心距差异≤5 mm[例(%)]Femoral offset≤5 mm	前倾角差异[°，(±s)])Difference of anteversion
常规组Convention group	50	5.6±2.9	24(48.0)	6.5±3.4	32(64.0)	9.7±4.6
导向器组PSG group	50	1.6±1.2	50(100.0)	3.1±1.4	42(84.0)	5.2±2.5
统计值Statistical value		t＝9.012	χ²＝35.135	t＝6.538	χ²＝5.198	t＝6.078
P值		<0.001	<0.001	<0.001	0.023	<0.001

表3 THA围手术期指标(±s)

Table 3 Perioperative outcomes in THA

组别Groups	髋数Number of hips	手术时间(min)Operation time	术中失血量(ml)Intraoperative blood loss	总失血量(ml)Total blood loss
常规组Convention group	50	75±12	467±72	686±153
导向器组PSG group	50	80±15	481±76	713±156
t值		1.98	1.006	0.867
P值		>0.05	>0.05	>0.05

表3 THA围手术期指标(±s)

Table 3 Perioperative outcomes in THA

组别Groups	髋数Number of hips	手术时间(min)Operation time	术中失血量(ml)Intraoperative blood loss	总失血量(ml)Total blood loss
常规组Convention group	50	75±12	467±72	686±153
导向器组PSG group	50	80±15	481±76	713±156
t值		1.98	1.006	0.867
P值		>0.05	>0.05	>0.05

表4 患者术后VAS评分及HSS评分(±s)

Table 4 VAS and HSS scores after operation

组别Groups	髋数Number of hips	术后VAS评分VAS after operation
组别Groups	髋数Number of hips	7 d Seven days	1个月One month	3个月Three months	6个月Six months	12个月Twelve months
常规组Convention group	50	2.8±0.8	1.7±0.6	1.3±0.4	0.9±0.5	0.7±0.5
导向器组PSG group	50	2.7±0.6	1.5±0.5	1.2±0.4	0.8±0.4	0.6±0.4
F值		时间效应249.8	交互效应0.181	组间效应6.545
P值		<0.001	>0.05	0.011
组别Groups	髋数Number of hips	术后HHS评分HHS after operation
组别Groups	髋数Number of hips	7 d Seven days	1个月One month	3个月Three months	6个月Six months	12个月Twelve months
常规组Convention group	50	72.6±6.7	82.9±5.0	90.1±3.3	92.1±2.4	93.2±1.2
导向器组PSG group	50	78.5±6.8	87.3±4.7	93.1±2.6	93.4±1.7	93.8±1.3
F值		时间效应：341.1;交互效应：7.088;组间效应：68.91
P值		均为<0.001

表4 患者术后VAS评分及HSS评分(±s)

Table 4 VAS and HSS scores after operation

组别Groups	髋数Number of hips	术后VAS评分VAS after operation
组别Groups	髋数Number of hips	7 d Seven days	1个月One month	3个月Three months	6个月Six months	12个月Twelve months
常规组Convention group	50	2.8±0.8	1.7±0.6	1.3±0.4	0.9±0.5	0.7±0.5
导向器组PSG group	50	2.7±0.6	1.5±0.5	1.2±0.4	0.8±0.4	0.6±0.4
F值		时间效应249.8	交互效应0.181	组间效应6.545
P值		<0.001	>0.05	0.011
组别Groups	髋数Number of hips	术后HHS评分HHS after operation
组别Groups	髋数Number of hips	7 d Seven days	1个月One month	3个月Three months	6个月Six months	12个月Twelve months
常规组Convention group	50	72.6±6.7	82.9±5.0	90.1±3.3	92.1±2.4	93.2±1.2
导向器组PSG group	50	78.5±6.8	87.3±4.7	93.1±2.6	93.4±1.7	93.8±1.3
F值		时间效应：341.1;交互效应：7.088;组间效应：68.91
P值		均为<0.001

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Randomized control trial of patient-specific femoral guide using for primary total hip arthroplasty

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Randomized control trial of patient-specific femoral guide using for primary total hip arthroplasty