Departmaent of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, 123, Ta Pei Road, Niao Sung District, Kaohsiung City, Taiwan.
J Orthop Surg Res. 2023 Mar 28;18(1):254. doi: 10.1186/s13018-023-03534-w.
Computer-assisted surgical navigation has been used in total knee arthroplasty (TKA) procedures for years trying to the accuracy of prosthesis placement. We conducted this prospective randomized clinical trial to compare the accuracy of the radiographic parameters of the prosthesis, total blood loss (TBL), and related complications, between a new pinless navigation system (Stryker OrthoMap Express Knee Navigation) and conventional method in patients undergoing minimally invasive (MIS) TKA procedures.
A consecutive series of 100 patients underwent unilateral primary TKA were randomly assigned into two groups: navigation group and convention group. The radiographic parameters of the knee implant and the alignment of lower limb were measured at 3 months after surgery. TBL was calculated according to Nadler's method. The duplex ultrasonography of both lower limbs was performed in all patients to detect the presence of deep-vein thrombosis (DVT).
Totally, 94 patients have completed the radiographic measures. Only the coronal femoral component angle in the navigation group (89.12° ± 1.83°) had significant differences from that in the convention group (90.09° ± 2.18°) (p = 0.022). There were no differences in the rate of outliers. The mean TBL in the navigation group was 841 ± 267 mL, which was similar to that in the convention group at 860 ± 266 mL (p = 0.721). Postoperative DVT risk did not differ between the two groups (2% vs. 0%, p = 0.315).
This pinless navigation TKA showed a comparable acceptable alignment compared with conventional MIS-TKA. There were no differences regarding postoperative TBL between the two groups.
计算机辅助手术导航已在全膝关节置换术(TKA)中使用多年,旨在提高假体放置的准确性。我们进行了这项前瞻性随机临床试验,以比较新的无针导航系统(Stryker OrthoMap Express Knee Navigation)和传统方法在微创(MIS)TKA 手术中对假体放射参数、总失血量(TBL)和相关并发症的准确性。
连续系列的 100 例单侧初次 TKA 患者被随机分为两组:导航组和常规组。术后 3 个月测量膝关节植入物的放射参数和下肢的对线。根据 Nadler 法计算 TBL。所有患者均行下肢双功超声检查以检测深静脉血栓形成(DVT)的存在。
共有 94 例患者完成了放射学测量。只有导航组的冠状股骨组件角度(89.12°±1.83°)与常规组(90.09°±2.18°)有显著差异(p=0.022)。两组的离群率无差异。导航组的平均 TBL 为 841±267ml,与常规组的 860±266ml 相似(p=0.721)。两组术后 DVT 风险无差异(2%对 0%,p=0.315)。
与传统的 MIS-TKA 相比,这种无针导航 TKA 显示出可接受的相似对线。两组间术后 TBL 无差异。