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髓内钉与钢板治疗腓骨完整的胫骨干骨折的比较:一项随机对照试验。

Comparison of intramedullary nail and plating in treatment of diaphyseal tibial fractures with intact fibulae: A randomized controlled trial.

作者信息

Saied Alireza, Ostovar Mohsen, Mousavi Alia Ayatollahi, Arabnejhad Fateme

机构信息

Neuroscience Research Center, Dr. Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran.

Department of Orthopedics, Dr. Bahonar Hospital Kerman University of Medical Sciences, Kerman, Iran.

出版信息

Indian J Orthop. 2016 May-Jun;50(3):277-82. doi: 10.4103/0019-5413.181793.

Abstract

BACKGROUND

Tibial fracture without concomitant fibular fracture is an injury that has long attracted notice for the fact that it sometimes heals cleanly, other times causes various problems when the bone does not heal, or misaligns. In this randomized clinical trial, we assessed two treatment modalities plating and intramedullary nailing for treatment of closed, noncomminuted tibial fractures with intact fibulae.

MATERIALS AND METHODS

During the three year period, 1470 patients with leg fractures were treated and out of which, 114 were eligible to enter the study. Of the eligible patients, 73 were recruited to enter the trial, and ultimately 69 of these were followed for at least one year. The patients were randomized into two groups, one of which was treated by plating of the fracture, the other group by intramedullary nailing, both of which are standard surgical procedures. The primary variables that influenced the outcome of the procedures in both treatments were the duration of surgery, the amount of bleeding, the time to union, the need to repeat surgery to achieve union, the need to remove a device, and patients' complaints about pain or discomfort in the limb.

RESULTS

One case of nonunion occurred in the group treated with intramedullary nailing and one of the patients in this group developed late, deep infection in the screws location, which was resolved by screw removal (P = 0.285 and P = 0.478, respectively). In both groups the tibial fractures achieved union in about 4 months, though the intramedullary group underwent more operations to achieve union (dynamization was performed in 4 patients, representing 12.1% of the patients in this group, P = 0.047). During the followup period, the incidence of implant removal (after union) was not statistically significant between the two groups: two patients (6.1%) in the intramedullary group and four patients (11.1%) in the plate group (P = 0.675) had implants removed. Of the other studied variables, the difference between the two groups was statistically significant only with regard to patients' complaints of pain in the limb and the number of individuals with knee pain (in both cases, P = 0.001). In the intramedullary group, 18 patients had no complaints (54.4%) and 13 complained of knee pain (39.4%), while in the plate group 29 had no complaints (80.6%).

CONCLUSION

Based upon the findings of the present study, both the methods studied are suitable treatments for closed noncomminuted isolated tibial fractures, but the patients in whom intramedullary nails are used are more likely to require additional surgeries to achieve union, and probably will have more complaints of pain in their limbs or knees.

摘要

背景

单纯胫骨骨折长期以来备受关注,因为它有时能顺利愈合,有时在骨折不愈合或错位时会引发各种问题。在这项随机临床试验中,我们评估了两种治疗方式——钢板固定和髓内钉固定——用于治疗闭合性、非粉碎性且腓骨完整的胫骨骨折。

材料与方法

在三年期间,共治疗了1470例腿部骨折患者,其中114例符合纳入本研究的条件。在符合条件的患者中,73例被招募进入试验,最终其中69例至少随访了一年。患者被随机分为两组,一组采用骨折钢板固定治疗,另一组采用髓内钉固定治疗,这两种都是标准的外科手术方法。影响两种治疗方式手术结果的主要变量包括手术时长、出血量、愈合时间、为实现愈合而需再次手术的必要性、取出内固定装置的必要性以及患者对肢体疼痛或不适的主诉。

结果

髓内钉固定组发生1例骨不连,该组1例患者在螺钉部位出现晚期深部感染,通过取出螺钉得以解决(分别为P = 0.285和P = 0.478)。两组的胫骨骨折均在约4个月时实现愈合,尽管髓内钉固定组为实现愈合接受了更多手术(4例患者进行了动力化操作,占该组患者的12.1%,P = 0.047)。在随访期间,两组之间取出内固定装置(愈合后)的发生率无统计学差异:髓内钉固定组有2例患者(6.1%)取出了内固定装置,钢板固定组有4例患者(11.1%)取出了内固定装置(P = 0.675)。在其他研究变量中,两组之间仅在患者对肢体疼痛的主诉以及膝关节疼痛患者数量方面存在统计学差异(在这两种情况下,P = 0.001)。在髓内钉固定组中,18例患者无主诉(54.4%),13例患者主诉膝关节疼痛(39.4%),而在钢板固定组中,29例患者无主诉(80.6%)。

结论

基于本研究的结果,所研究的两种方法都是治疗闭合性非粉碎性孤立胫骨骨折的合适方法,但使用髓内钉的患者更有可能需要额外手术来实现愈合,并且可能会有更多肢体或膝关节疼痛的主诉。

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