动力髋螺钉、股骨近端抗旋髓内钉与联合加压交锁髓内钉系统修复股骨转子间骨折

doi:10.3969/j.issn.2095-4344.2015.22.019

中国组织工程研究 ›› 2015, Vol. 19 ›› Issue (22): 3543-3549.doi: 10.3969/j.issn.2095-4344.2015.22.019

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇下一篇

动力髋螺钉、股骨近端抗旋髓内钉与联合加压交锁髓内钉系统修复股骨转子间骨折

邵进，杨铁毅，王治，张岩，刘树义

上海市浦东新区公利医院/第二军医大学附属公利医院骨科，上海市 200135

收稿日期:2015-05-08 出版日期:2015-05-28 发布日期:2015-05-28
通讯作者: 杨铁毅，主任医师，上海市浦东新区公利医院/第二军医大学附属公利医院骨科，上海市 200135
作者简介:邵进，男，1977年生，山东省乳山市人，汉族，2009年上海交通大学毕业，博士，主治医师，主要从事骨与关节损伤的研究
基金资助:
国家自然科学基金(81201367)；浦东新区卫生系统重点学科建设资助项目(PWZx2014-09)

Dynamic hip screw, proximal femoral nail antirotation and InterTan nail for intertrochanteric fractures

Shao Jin, Yang Tie-yi, Wang Zhi, Zhang Yan, Liu Shu-yi

Department of Orthopedics, Shanghai Pudong New Area Gongli Hospital, Second Military Medical University, Shanghai 200135, China

Received:2015-05-08 Online:2015-05-28 Published:2015-05-28
Contact: Yang Tie-yi, Chief physician, Department of Orthopedics, Shanghai Pudong New Area Gongli Hospital, Second Military Medical University, Shanghai 200135, China
About author:Shao Jin, M.D., Attending physician, Department of Orthopedics, Shanghai Pudong New Area Gongli Hospital, Second Military Medical University, Shanghai 200135, China
Supported by:
the National Natural Science Foundation of China, No. 81201367; the Key Discipline Construction Project of Pudong Health Bureau of Shanghai, No. PWZx2014-09

摘要/Abstract

摘要：

背景：髓外固定系统包括动力髋螺钉常用于治疗股骨转子间骨折；但在不稳定性股骨转子间骨折的患者中，髓外固定系统往往会导致骨折固定失败。髓内固定系统包括股骨近端抗旋髓内钉和联合加压交锁髓内钉系统广泛用于治疗不稳定性股骨转子间骨折。
目的：比较髓外固定系统包括动力髋螺钉，股骨近端抗旋髓内钉和联合加压交锁髓内钉系统治疗股骨转子间骨折的疗效。
方法：检索万方数据库、PubMed、Embase、Medline和Cochrone library从1990年1月到2014年11月的文献。对髓外固定系统包括动力髋螺钉，股骨近端抗旋髓内钉和联合加压交锁髓内钉系统的相关文献进行筛选。
结果与结论：通过对346篇文献进行筛选，共有13篇文献符合标准，其中共纳入1 271例不同类型的股骨转子间骨折患者。与髓外固定系统包括动力髋螺钉组相比，股骨近端抗旋髓内钉组和联合加压交锁髓内钉系统组患者手术时间更短，且出血量更少，但3种固定方法患者康复时间和愈后Harris评分差异无显著性意义。此外，股骨近端抗旋髓内钉和联合加压交锁髓内钉系统的疗效相似。提示与髓外固定系统包括动力髋螺钉相比，股骨近端抗旋髓内钉和联合加压交锁髓内钉系统虽可优化手术过程，但不能提升术后恢复效果。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 植入物, 骨植入物, 动力髋螺钉, 联合加压交锁髓内钉系统, 股骨转子间骨折, Meta分析, 前瞻性实验, 股骨近端抗旋髓内钉, 国家自然科学基金

Abstract:

BACKGROUND: The extramedullary fixation system including dynamic hip screw (DHS) is commonly used in treatment of Intertrochanteric fracture. However, in patients with unstable intertrochanteric fracture, extramedullary fixation system often leads to the failure of fracture fixation. Intramedullary fixation system including both proximal femoral nail antirotation (PFNA) and InterTan nail has been widely used in the treatment of unstable intertrochanteric fractures.
OBJECTIVE: To compare the therapeutic effects of extramedullary fixation system containing DHS, PFNA and InterTan nail in the treatment of intertrochanteric fracture.
METHODS: Literatures were searched in Wanfang, PubMed, Embase, Medline, the Cochrane library to screen literatures published from January 1990 to November 2014. Relevant studies addressing extramedullary fixation system containing DHS, PFNA and InterTan nail were screened.
RESULTS AND CONCLUSION: 346 articles were screened, and 13 of them were in accordance with the inclusion criteria. 1 271 patients with different types of intertrochanteric fracture were assessed in this study. Compared to DHS group, patients treated with PFNA and InterTan nail had shorter operation time and less blood loss. No significant difference in rehabilitation time and Harris score was detected among three kinds of fixation methods. Additionally, PFNA and InterTan nail had a similar effect. These findings verify that compared with DHS, PFNA and InterTan nail can optimize the surgery, but cannot elevate postoperative outcomes.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Bone Nails, Hip Fractures, Femur, Internal Fixators

中图分类号:

R318

邵进，杨铁毅，王治，张岩，刘树义. 动力髋螺钉、股骨近端抗旋髓内钉与联合加压交锁髓内钉系统修复股骨转子间骨折[J]. 中国组织工程研究, 2015, 19(22): 3543-3549.

Shao Jin, Yang Tie-yi, Wang Zhi, Zhang Yan, Liu Shu-yi. Dynamic hip screw, proximal femoral nail antirotation and InterTan nail for intertrochanteric fractures[J]. Chinese Journal of Tissue Engineering Research, 2015, 19(22): 3543-3549.

图/表（结果） 11

Search results and characteristics
A total of 346 citations were obtained via database searches; thirteen met the inclusion criteria for this study (Figure 1). A total of 1 271 patients with different intertrochanteric fracture types were involved in which 563 patients were treated with DHS, 501 patients with PFNA and 234 patients with InterTan nail, and the information in these citations is summarized in Table 1. The quality assessment of the included studies is shown in Table 2.

Meta-analysis results
Operation time
Operation time was reported in 12 studies[20-31]. There was a significant heterogeneity in these trials (Figure 2). The results of meta-analysis indicated that compared with the DHS group, operation time was shorter in both PFNA group (WMD=-34.85, 95% CI: -44.7 to -25, P < 0.001) and InterTan group (WMD = -21.46, 95% CI: -28.27 to -14.56, P < 0.001). PFNA group had a shorter operation time than InterTan group (WMD = -9.92, 95% CI: -18.45 to -1.42, P = 0.02).

Blood loss
The data of blood loss were reported in 12 studies[20-31]. A significant heterogeneity was observed in these trials (Figure 3). The results of meta-analysis showed that the patients treated with PFNA or InterTan nail had an obviously less blood loss than patients treated with DHS (PFNA vs. DHS: WMD=-229.98, 95% CI:-260.02 to -199.95, P < 0.001, and InterTan vs. DHS: WMD=-185.92, 95% CI: -253.04 to -118.8, P < 0.001), while there was no significant difference between the PFNA and InterTan nail treatment groups (WMD=-10.82, 95% CI: -25.42 to 3.77, P= 0.15).

Fracture healing time
The data of fracture healing time were reported in six studies[20-22, 24-26]. Compared to DHS, patients treated with PFNA had a shorter fracture healing time (WMD=-3.31, 95% CI:-6.27 to 0.00, P=0.05). There was no significant difference in fracture healing time between InterTan nail and DHS (WMD=-0.56, 95% CI:-3.81 to 2.68, P=0.73), and between PFNA and InterTan nail (WMD=0.11, 95% CI: -0.26 to 0.48, P=0.55; Figure 4).

Harris score
Patients with a Harris score above 80 at the last follow up were regarded as well recovered. The number of patients who had an above 80 score was offered in all 6 studies[22, 24, 26, 30-32]. The results showed that there was no significant difference in these three fixations (Figure 5).

Sensitivity analysis and publication bias
Sensitivity analysis was performed to evaluate the stability of the results of this meta-analysis (Table 4, Figures 6-8). The outcome of hospitalization time between PFNA and DHS was not robust, which suggested that the result was not credible. Besides that, the other outcomes were credible. Publication bias was evaluated by Begg’s test (PFNA vs. DHS, P=0.7 > 0.5; InterTan vs. DHS, P=0.65 > 0.5; PFNA vs. InterTan, P=0.59 > 0.5). There was no publication bias in this meta-analysis.

参考文献

[1] Butler M, Forte ML, Joglekar SB, et al. Evidence summary: systematic review of surgical treatments for geriatric hip fractures. J Bone Joint Surg Am. 2011;93(12):1104-1115.
[2] Swart E, Makhni EC, Macaulay W, et al. Cost-effectiveness analysis of fixation options for intertrochanteric hip fractures. J Bone Joint Surg Am. 2014;96(19):1612-1620.
[3] Haidukewych GJ. Intertrochanteric fractures: ten tips to improve results. Instr Course Lect. 2010;59:503-509.
[4] Zhang K, Zhang S, Yang J, et al. Proximal femoral nail vs. dynamic hip screw in treatment of intertrochanteric fractures: a meta-analysis. Med Sci Monit. 2014;20:1628-1633.
[5] Albareda J, Laderiga A, Palanca D, et al. Complications and technical problems with the gamma nail. Int Orthop. 1996; 20(1):47-50.
[6] Miedel R, Ponzer S, Törnkvist H, et al. The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomised, controlled trial. J Bone Joint Surg Br. 2005;87(1):68-75.
[7] Windolf J, Hollander DA, Hakimi M, et al. Pitfalls and complications in the use of the proximal femoral nail. Langenbecks Arch Surg. 2005;390(1):59-65.
[8] Chen Y, Liu S, Lin P, et al. Comparative biomechanical study of reversed less invasive stabilization system and proximal femoral nail antirotation for unstable intertrochanteric fractures. Chin Med J (Engl). 2014;127(23):4124-4129.
[9] Li J, Cheng L, Jing J. The Asia proximal femoral nail antirotation versus the standard proximal femoral antirotation nail for unstable intertrochanteric fractures in elderly Chinese patients. Orthop Traumatol Surg Res. 2015;101(2):143-146.
[10] Huang Y, Zhang C, Luo Y. A comparative biomechanical study of proximal femoral nail (InterTAN) and proximal femoral nail antirotation for intertrochanteric fractures. Int Orthop. 2013; 37(12):2465-2473.
[11] Rupprecht M, Grossterlinden L, Ruecker AH, et al. A comparative biomechanical analysis of fixation devices for unstable femoral neck fractures: the Intertan versus cannulated screws or a dynamic hip screw. J Trauma. 2011;71(3):625-634.
[12] Wang Q, Yang X, He HZ, et al. Comparative study of InterTAN and Dynamic Hip Screw in treatment of femoral intertrochanteric injury and wound. Int J Clin Exp Med. 2014;7(12):5578-5582.
[13] Utrilla AL, Reig JS, Muñoz FM, et al. Trochanteric gamma nail and compression hip screw for trochanteric fractures: a randomized, prospective, comparative study in 210 elderly patients with a new design of the gamma nail. J Orthop Trauma. 2005;19(4):229-233.
[14] Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1-12.
[15] Zeng L, Liang X, Liu Q, et al. The Predictive Value of Circulating Tumor Cells in Ovarian Cancer: A Meta Analysis. Int J Gynecol Cancer. 2015. in press.
[16] Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005;5:13.
[17] Shao Y, Geng Y, Gu W, et al. Prognostic significance of microRNA-375 downregulation in solid tumors: a meta-analysis. Dis Markers. 2014;2014:626185.
[18] Tobias A. Assessing the Influence of a Single Study in the Meta-Analysis Estimate. Stata Tech Bul. 1999;8:15-17.
[19] van Enst WA, Ochodo E, Scholten RJ, et al. Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study. BMC Med Res Methodol. 2014;14:70.
[20] Jiang ZH, Li NJ, Zhu QJ, et al. Comparison of InterTAN and dynamic hip screw in treatment of femoral intertrochanteric fractures. Zhongguo Yishi Jinxiu Zazhi. 2013; 36(5):4-7.
[21] He JP, Zhang SM, Qiao L, et al. Comparative study of the selection of intramedullary fixation in the treatment of femoral intertrochanteric fractures in senile osteoporotic patients. Zhongguo Guzhi Shusong Zazhi. 2013;19(3): 268-270.
[22] Chen H, Yin YS, Chen Y, et al. Comparison of Intertan, PFNA and Dynamic Hip Screw in Treatment of Femorai Intertrochanteric Fractures. Zhongguo Yiyao Zhinan. 2013; 1(35):405-406.
[23] Lin YJ, Li J, Lin YS, et al. Comparison of the curative effect on treatment of intertrochanteric fractures with InterTAN、PFNA and DHS. Jinan Daxue Xuebao: Ziran Kexue yu Yixue Ban. 2014;35(3):294-298.
[24] Deng JF, Zhou S, Niu HQ. Type of intertrochanteric fracture and choice of internal fixation screw. Zhongguo Zuzhi Gongcheng Yanjiu. 2012;16(48):8976-8982.
[25] Wang YG, Chen M, Hu JK, et al. Comparison of three fixations for treatment of intertrochanteric femoral fractures in the elderly. Zhongguo Gu Shang. 2013;26(8):651-655.
[26] Zhang XD, Liu YW, Jia YD, et al. Comparison of Three Fixation for Treatment of Intertrochanteric Femoral Fractures. Shiyong Guke Zazhi. 2014;20(4):350-354.
[27] Garg B, Marimuthu K, Kumar V, et al. Outcome of short proximal femoral nail antirotation and dynamic hip screw for fixation of unstable trochanteric fractures. A randomised prospective comparative trial. Hip Int. 2011;21(5):531-536.
[28] Xu YZ, Geng DC, Mao HQ, et al. A comparison of the proximal femoral nail antirotation device and dynamic hip screw in the treatment of unstable pertrochanteric fracture. J Int Med Res. 2010;38(4):1266-1275.
[29] Zou J, Xu Y, Yang H. A comparison of proximal femoral nail antirotation and dynamic hip screw devices in trochanteric fractures. J Int Med Res. 2009;37(4):1057-1064.
[30] Wang XB, Xu YZ, Geng DC, et al. Comparison of the rapeutic effect of Pfna with Dhs for intertrochanteric fractures in elderly patients. Suzhou Daxue Xuebao: Yixue Ban. 2010;30(3):639-641.
[31] Zuo WS, Dai ZT, Tian JW. Comparison of therapeutic effect of PFNA with DHS in intertrochanteric fractures. Zhongguo Xiandai Yixue Zazhi. 2011;21(4):475-478.
[32] Lai XL, Li F, Liu DX, et al. Comparison of the rapeutic effect of Pfna with Dhs for intertrochanteric fractures. Zhongguo Yishi Jinxiu Zazhi. 2011;34(26):70-72.
[33] Simmonds MC, Higgins JP, Stewart LA, et al. Meta-analysis of individual patient data from randomized trials: a review of methods used in practice. Clin Trials. 2005;2(3):209-217.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

引言

The incidence of intertrochanteric fractures has increased due to the rising age of the population[1]. The extramedullary fixation system dynamic hip screws (DHS) is the most commonly used implant and relatively less expensive[2]. Despite the wide use of DHS, treatment with DHS was associated with high risk of fixation failure in unstable intertrochanteric fractures[3]. Intramedullary nails, both Gamma nail and proximal femoral nail, are widely used in the treatment of unstable intertrochanteric fractures due to biomechanical advantages[4]. However, these two intramedullary fixation devices often result in femoral shaft fracture[5], fixation failure[6] and distal locking complications[7].

Proximal femoral nail antirotation (PFNA), a modification of proximal femoral nail with a helical neck blade, could obtain high stability to prevent collapse and rotation[8]. PFNA avoids bone loss and improves purchase in the femoral head by radial compaction of the cancellous bone around the blade during insertion. However, it is not suitable for some patients because of its large proximal diameter[9].

Another new device, InterTan nail with two cephalocervical screws allows linear intraoperative compression and rotational stability of the head neck fragments. Compared with DHS and PFNA, InterTan nail has some biomechanical benefits for internal fixation of intertrochanteric fractures[10-12]. Clinical studies showed that InterTan nail could also be used for treatment of intertrochanteric fractures[13].

Previous studies have compared the advantage and disadvantage among PFNA,
InterTan nail and DHS, but single study

with small sample size has different results and the management of intertrochanteric fracture still remains controversial. Therefore, we performed this meta-analysis based on all relevant clinical trials to assess the PFNA, InterTan nail and DHS fixation in intertrochanteric fractures.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

材料方法

Search strategy
Databases (Wanfang, Embase, Medline, PubMed and Cochrane library) were searched for randomized controlled trials from January 1990 to December 2014. The key words “PFNA” or “Proximal Femoral Nail Antirotation” and “DHS” or “dynamic hip screws” and “InterTan nail” and “intertrochanteric fractures” or “peritrochanteric fractures” or “pertrochanteric fractures” were used in screening relevant citations. Language restriction was not imposed in our search.

Inclusion criteria
The inclusion criteria were: (1) the studies were clinically controlled trials; (2) the size of each group was above 20 persons; (3) the studies provided the data at least with one of main outcomes, including operation time, blood loss, fracture healing time, and Harris scores.

Data extraction and quality assessment
The following information was extracted from each study: first author name, year of publication, number of patients, operation time, blood loss, fracture healing time, and Harris scores. The Jadad score was used to assess the quality of prospective studies^[14]and a modified version of the Newcastle-Ottawa scale was used to assess the quality of the retrospective trials^[15].

Data analysis
Data analysis was performed using the Stata12. For each individual study, dichotomous data were reported as odds ratio with 95% confidence interval (CI) and continuous data were reported as weighted mean difference (WMD) with 95% CI. Medians and interquartile ranges were used to calculate mean and standard deviation respectively^[16]. Heterogeneity between studies was assessed by I-square (I²) test. A significant level of no less than 50% for I² test was considered as evidence of heterogeneity. Fixed-effect model was used when there was no evidence of heterogeneity, otherwise random-effect model was chosen. To evaluate the stability of the results of this meta-analysis, we performed a one-way sensitivity analysis^[17]. Sensitivity analysis was performed by sequential omission of individual studies to evaluate the credibility of outcomes in this meta-analysis^[18]. Publication bias was evaluated by Begg’s test and P > 0.05 was regarded as no publication bias^[19].

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

讨论

DHS and intramedullary nails are the main surgical options for intertrochanteric fractures. Many studies have compared the DHS, InterTan nail and PFNA in intertrochanteric fractures, but there are inconsistent results among these studies. To further assess the effect of the three fixations, we performed this meta-analysis to compare DHS, InterTan nail and PFNA in intertrochanteric fractures. Our meta-analysis showed patients fixed with PFNA had shorter operation time than those with InterTan nail (WMD = -9.92, 95% CI: -18.45 to -1.42, P=0.02) and DHS (WMD =-34.85, 95% CI: -44.7 to -25, P < 0.001). Both PFNA and InterTan nail groups had less blood loss than DHS group (PFNA vs. DHS: WMD=-229.98, 95% CI: -260.02 to -199.95, P < 0.001, and InterTan vs. DHS: WMD=-185.92, 95% CI:-253.04 to -118.8, P < 0.001). However, there was no difference of these items between PFNA group and InterTan group. For fracture healing time, these three fixations have no significant difference. We also analyzed the Harris score at the last time of the follow up and no difference was found between these fixations.

It was noted that heterogeneity was obviously found in our study. The possible explanation may be: firstly, the variation in the skills of surgeons and different types of intertrochanteric fractures may contribute to the heterogeneity. For example, the operation time of PFNA group in Xu et al ^[28] study was significantly longer than that of DHS group, which may due to the unskilled investigators for PFNA operation and these data were excluded. Secondly, the eligibility criteria for inclusion of patients with intertrochanteric fractures were different in these studies. We were unable to perform a subgroup analysis according to the stable or unstable fracture because only a few studies offered the data of stable and unstable fractures. To confirm
whether the results were credible, we performed the sensitivity analysis. According to our results, the outcomes of operation time and blood loss between PFNA and InterTan nail groups were not credible. For blood loss, after omitting the study of Lin et al ^[23], there was significant difference between PFNA and InterTan groups, and the results were credible. The reason may be that Lin et al ^[23]have only included patients with fracture type of Evans I-III, while the other studies have included patient with Evans I-V. To unify the outcome measurement and fracture type, in an individual patient, data meta-analysis is needed^[33]. Besides, the effect of the fixation strategies may be different in treating various types of fractures, and these differences need further study to verify.

There are also some limitations in our study. Firstly, subgroup analysis for different types of fracture was not performed, because not all of the studies offered the data according to the different fracture types. Secondly, the function outcomes were not included in our study, because few studies have offered the function outcomes in their studies. Thirdly, safety was not analyzed due to the various definitions of complication and limited studies. Despite these limitations, we believe that our analysis could contribute to clinical option of fixation for intertrochanteric fractures.

In conclusion, compared to DHS group, patients treated with PFNA and InterTan nail have shorter operation time and less blood loss. There were no differences in fracture healing time and Harris scores for these three fixations. However, there was no significant difference between PFNA and InterTan groups in all the terms. In addition, large-sample randomized controlled trials are needed to confirm our findings. Furthermore, the effect of long-term period needs further study.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

动力髋螺钉、股骨近端抗旋髓内钉与联合加压交锁髓内钉系统修复股骨转子间骨折

Dynamic hip screw, proximal femoral nail antirotation and InterTan nail for intertrochanteric fractures

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