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

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

Abstract

Abstract:

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

Xin Jin, Mao Xie, Yun Liu, Cao Yang, Shuhua Yang, Weihua Xu. Randomized control trial of patient-specific femoral guide using for primary total hip arthroplasty[J]. Chinese Journal of Joint Surgery(Electronic Edition), 2023, 17(06): 780-787.

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Figures/Tables 6

References 30

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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

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

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

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

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

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