目的探讨国产手术导航系统辅助全髋关节置换术(THA)的有效性和安全性。

选择赤峰市医院骨关节科2021年5月至9月收治的符合入选标准的拟接受THA的患者42例，通过中央随机化系统将患者分为试验组(n＝19)与对照组(n＝23)。2组患者入院后常规行患侧髋关节X线、全骨盆CT等术前相关检查，试验组患者术中应用国产手术导航系统辅助完成THA，对照组患者使用传统手术方法完成THA。2组患者术后常规预防感染、预防下肢深静脉血栓，并行髋关节功能锻炼。记录2组患者手术时间、术中出血量。术后1个月，通过影像学检查测量髋臼假体角度并计算2组患者髋臼假体角度位于Lewinnek安全区的比例。术后1个月，比较2组患者西安大略和麦克马斯特大学骨关节炎指数(WOMAC)量表评估评分、Harris髋关节评分、SF-36健康调查评分、髋关节活动度、关节脱位率和并发症发生率。数据行独立样本t检验、χ²检验。

试验组手术时间为(107.7±25.3) min，较对照组[(80.2±21.7) min]延长，差异有统计学意义(t＝3.791，P<0.05)；试验组术中出血量为(281.6±151.1) mL，与对照组[(233.9±117.7) mL]比较，差异无统计学意义(t＝1.149，P＝0.257)。术后1个月，试验组髋臼假体角度位于Lewinnek安全区的比例为94.7%(18/19)，与对照组[60.9%(14/23)]比较，比较差异有统计学意义(χ²＝6.579，P＝0.010。术后1个月，试验组组患者WOMAC量表评估评分、Harris髋关节评分、SF-36健康调查评分分别为(13.8±7.3)、(80.9±6.8)、(602.6±69.4)分，与对照组[(14.8±8.3)、(80.3±7.9)、(588.8±114.7)分]比较，差异均无统计学意义(t＝-0.409、0.276、0.458，P＝0.257、0.685、0.784、0.650)。术后1个月，试验组患者髋关节内收(15.3±4.6)°，外展(33.3±7.7)°，内旋(13.7±4.4)°，外旋(23.9±14.4)°，屈曲(100.0±10.8)°，与对照组[内收(15.7±4.6)°、外展(32.8±7.0)°、内旋(12.6±4.7)°、外旋(19.1±8.5)°、屈曲(95.4±12.5)°]比较，差异均无统计学意义(t＝-0.274、0.146、0.759、1.348、1.251，P＝0.785、0.885、0.452、0.185、0.218)。术后1个月，试验组患者术后无关节脱位发生，对照组患者关节脱位率为4.3%(1/23)，2组比较差异无统计学意义(χ²＝0.000，P＝1.000)；试验组并发症发生率为21.1%(4/19)，与对照组[13.0%(3/23)]比较，差异无统计学意义(χ²＝0.077，P＝0.782)。

国产手术导航系统辅助THA较传统THA髋臼假体角度更加精准，安全性更高，但是手术时间相对延长，术后早期临床效果相同。

To investigate the efficacy and safety of domestic surgical navigation system in total hip arthroplasty (THA).

Forty-two patients who met the inclusion criteria and planned to receive THA and admitted to the Department of Bone and Joint, Chifeng Hospital from May to September 2021 were selected. The patients were divided into the experimental group (n=19) and the control group (n=23) by the central randomization system. After admission, patients in the two groups underwent routine preoperative related examinations such as X-ray films of the affected hip joint and whole pelvis CT. The patients in the experimental group were treated with domestic surgical navigation system to assist in completing THA during the operation. While the patients in the control group were treated with traditional surgical methods to complete THA. All the patients received routine postoperative infection prevention, prevention of lower extremity deep venous thrombosis, and hip joint functional exercise. The operation time and intraoperative blood loss of the patients in the two groups were collected. At one month after operation, the acetabular prosthesis angle was measured by imaging examination to calculate the proportion of the acetabular prosthesis angle in the Lewinnek safe zone in the two groups. At one month after operation, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessment score, Harris hip score, SF-36 health survey score, hip range of motion, joint dislocation rate and complication rate were compared between the two groups. Data were processed with independent samples t test, chi-square test.

The operation time of the experimental group was (107.7±25.3) min, which was longer than that of the control group [(80.2±21.7) min], and the difference was statistically significant (t=3.791, P<0.05); the intraoperative blood loss of the experimental group was (281.6±151.1) mL, compared with the control group [(233.9±117.7) mL], the difference was not statistically significant (t=1.149, P= 0.257). At one month after operation, the proportion of the acetabular prosthesis angle in the Lewinnek safe zone in the experimental group was 94.7% (18/19), compared with the control group [60.9% (14/23)], the difference was statistically significant (χ²=6.579, P= 0.010). At one month after operation, the WOMAC scale evaluation score, Harris hip score, and SF-36 health survey score were (13.8±7.3), (80.9±6.8), (602.6±69.4) points, respectively, which were higher than those of the control group [(14.8±8.3), (80.3±7.9), (588.8±114.7) points], the differences were not statistically significant (t=-0.409, 0.276, 0.458; P=0.685, 0.784, 0.650). At one month after operation, , the hip joints in the experimental group were adduction (15.3±4.6)°, abduction (33.3±7.7)°, internal rotation (13.7±4.4)°, external rotation (23.9±14.4)°, flexion (100.0±10.8) °, compared with the control group [adduction (15.7±4.6)°, abduction (32.8±7.0)°, internal rotation (12.6±4.7)°, external rotation (19.1±8.5)°, flexion (95.4±12.5)°], the differences were not statistically significant (t=-0.274, 0.146, 0.759, 1.348, 1.251; P=0.785, 0.885, 0.452, 0.185, 0.218). There was no postoperative joint dislocation in the experimental group, while the joint dislocation rate in the control group was 4.3% (1/23), and there was no significant difference between the two groups (χ²=0.000, P=1.000). The incidence of complications in the experimental group was 21.1% (4/19), compared with the control group [13.0% (3/23)], the difference was not statistically significant (χ²=0.077, P=0.782).

The surgical navigation system assisted THA is more accurate and safer than the traditional THA acetabular prosthesis, but the operation time is relatively longer, and the early postoperative clinical effect is the same.