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Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e89

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Journal of Orthopaedics, Trauma and Rehabilitation

Journal homepages: www.e- jotr .com & www.ejotr .org

Original Article

Open reduction internal fixation versus external fixation with limitedinternal fixation for displaced comminuted closed pilon fractures: Arandomised prospective study切開復位開內固定與外固定有限內固定用於移位的粉碎性閉合Pilon骨折:隨機前瞻性研究

Rayan Ahmed, Kotb Ahmed*, Elmoatasem Elhussein M., Samir Shady, EL-Sobky Tamer A.,El-Hawi Ezzat, Mahran MahmoudDepartment of Orthopaedic Surgery, Faculty of Medicine, Ain-Shams University, 38 Abbasia, Cairo, Egypt

a r t i c l e i n f o

Article history:Received 11 February 2017Received in revised form9 June 2017Accepted 1 August 2017

Keywords:external fixationinternal fixationintraarticular ankle fracturesprospectivetibial plafond

* Corresponding author. Department of OrthopaedicAin-Shams University, 38 Abbasia, Cairo, Egypt. E-maidrakotb@live.com, drakotb@med.asu.edu.eg,shadelbeshry@yahoo.com, tamer.ahmed@med.asu.edezzathawi@hotmail.com, mahmoudmagran@gmail.co

https://doi.org/10.1016/j.jotr.2017.08.0012210-4917/Copyright©2018,HongKongOrthopaedic AssociaCC BY-NC-ND license (http://creativecommons.org/licenses/by

a b s t r a c t

Background: Pilon fractures involve the dome of the distal tibial articular surface. The optimal treatment forhigh-energy pilon fractures remains controversial. Some authors advocate the use of open reduction andinternal fixation (ORIF) to avoid articular incongruence. Others advocate the use of bridging external fixationwith limited internal fixation (EFLIF) to reduce soft tissue complications. Literature reports of prospectivestudies comparing the radioclinical outcomes of ORIF and EFLIF in high-energy fractures are scarce. Retro-spective studies have their limitations because of insufficient randomisation. The objective of this rando-mised prospective study is to compare the clinical, radiologic and functional outcomes of displaced andcomminuted closed pilon fractures, Rüedi and Allg€ower type II and III, treated by either ORIF or EFLIF.Materials and methods: Forty-two patients were selected for the study. Twenty-two patients weresubjected to ORIF and 20 patients were subjected to EFLIF. We used the American Orthopaedic Foot andAnkle Society score as a standard method of reporting clinical status of the ankle. Patients were followed-up clinically and radiologically for over 2 years after the surgical treatment.Results: The results of ORIF and EFLIF in treatment of high-energy pilon fractures are equally effective interms of functional outcomes and complication rates on the short term.Conclusion: Soft tissue integrity and fracture comminution seem to have a significant influence onoutcomes of intervention. A prospective multicentre study with a larger sample size that controls forother associated variables and comorbidities is warranted.Level of evidence: Level II.

中 文 摘 要

背景: Pilon骨折涉及脛骨遠端關節面的圓頂。高能量Pilon骨折的最佳治療方法仍然存在爭議。 一些作者主

張使用開放復位和內固定(ORIF)來避免關節不一致。 其他作者主張用橋接外固定和有限內固定(EFLIF)來減少

軟組織並發症。 比較ORIF和EFLIF在高能量骨折中的放射臨床結局的前瞻性研究的文獻報導很少。 回顧性研

究由於隨機化不足而有其局限性。 這項隨機前瞻性研究的目的是比較以ORIF或EFLIF治療移位的粉碎性閉合

Pilon骨折Rüedi和Allg€ower II型和III型的臨床、放射學和功能結果。

材料與方法: 選擇42例患者進行研究。二十二名患者接受了ORIF,二十名患者接受了EFLIF。我們使用美國骨科

腳踝學會(AOFAS)評分作為報告踝關節臨床狀態的標準方法。患者的臨床和放射學隨訪超過手術治療後兩年。

結果: ORIF和EFLIF治療高能量Pilon骨折的療效在短期內功能結局和並發症發生率方面同樣有效。

結論: 軟組織完整性和骨折粉碎似乎對手術結果有顯著影響。 具有較大樣本量的前瞻性多中心研究以控制其

他相關變量和合併症是有必要的。

Surgery, Faculty of Medicine,l: drahmedrayan@yahoo.com,

hmoatasem@yahoo.com,u.eg, tamersh@hotmail.com,m.

tionand theHongKongCollege ofOrthop-nc-nd/4.0/).

aedic Surgeons. Published byElsevier (Singapore) Pte Ltd. This is an openaccess articleunder the

A. Rayan et al. / Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e89 85

Introduction

Pilon fractures involve the dome of the distal tibial articular sur-face and extend into the adjacentmetaphysis. They are relatively rarefractures ranging from low- to high-energy injuries. The low-energyrotational injuries have been shown to have excellent functional re-sults with open reduction and internal fixation (ORIF). The high-energy axial-loading injuries have had uniformly moderate resultsand higher complication rates.1 These can be challenging to managebecause of the usual high-energy involved and the limited soft tissueenvelope that surrounds the distal tibia. The condition of the softtissues is crucial with respect to timing of definitive surgery andmethod of surgical fixation. Poor timing is associated with pooroutcomes. Soft tissues must be ready for the second insult dealt bysurgery.2e4 Additional treatment outcomes vary depending on mul-tiple factors such as degree of bony comminution, quality of reduc-tion, the surgeon's experience and associated injuries. Therefore, theoptimal treatment for high-energy pilon fractures remains contro-versial. Some authors advocate the use of ORIF to avoid articularincongruence and consequent posttraumatic arthritis and to maxi-mise long-term results.1,5,6 Others advocate the use of bridgingexternal fixationwith limited internal fixation (EFLIF) in high-energyfractures to reduce soft tissue-relatedcomplications andblood loss.2,7

Proponents of the EFLIF may argue that the necessity for ananatomical restoration of the articular surface is controversial anddoes not always correlate with the clinical outcome.8 Literature re-ports of prospective studies comparing between the radioclinicaloutcomes of ORIF and EFLIF in high-energy fractures are scarce.9 Thisinspired us to set up a prospective study to compare the clinical,radiologic and functional outcomes of displaced and comminutedclosed pilon fractures, Rüedi and Allg€ower type II and III,10 treated byeither ORIF or EFLIF. The authors declare that no conflict of interestexists. No financing was received for this study. The local ethicalcommittee authorised conducting this study.

Patients and methods

We carried out a two matched group, assessor-blinded pro-spective randomised clinical study comparing the results of ORIF tothat of EFLIF for closed displaced pilon fractures, Rüedi andAllg€ower type II and III. The study was conducted during the periodfrom February 2010 to December 2012. Patients were followed-upfor over 2 years after the surgical treatment.

Patient selection and randomisation

A total of 45 patients were randomised to the study. One patientrefused treatment. Two patientsdone to each groupdwere rand-omised, and they received planned treatment but dropped out.They had insufficient follow-up and incomplete data to be includedand analysed for the results. Therefore, 42 patients were selectedfor the study. Twenty-two patients were subjected to ORIF (GroupI), 14 males and eight females in that group. Twenty patients weresubjected to EFLIF (Group II), 13 males and seven females, and thestudy was conducted at the authors' institution. Patients wereexplained about the study, and written consent was obtained. Pa-tients were eligible if they were aged 18 years or more, with arecent (less than 3 weeks) closed intraarticular displaced distaltibial fractures of Rüedi and Allg€ower type II and III. Exclusioncriteria were other serious leg injuries sufficient to affect outcomeat 2 years such as peripheral angiopathy, neuropathy in the injuredlimb, multiple fractures, morbid obesity and compartment syn-drome. We included patients with bilateral fractures provided thatboth of the fractures met the inclusion criteria. Patients who con-sented to participate were randomised by flipping a coin 1:1 to

receive either ORIF or EFLIF. We used adaptive minimisation toavoid development of significant differences between the twogroups in some prognostic factors such as smoking status, Rüediand Allg€ower type fractures, and soft tissue injury severity. Bilateralfractures were allocated the same treatment on both sides.

Surgical interventions

The preliminary management for all participants was bed rest,analgesia, elevation of the foot and application of ice and a posteriorslab. Patients were subjected to plain radiographs, including ante-roposterior, mortise and lateral views centred over the ankle andfull-length radiographs of the leg including the knee and ankle.Targeted X-ray examinations were conducted on other areasdepending on clinical findings. Additionally, patients were routinelysubjected to computed tomography of the distal tibia and ankle joint.Soft tissue injury severity was assessed according to Oestern andTscherne classification.11 The classification has demonstrated anadequate level of intraobserver and interobserver agreement in tibialplateau and tibial pilon fractures.12 Surgical interventions wereperformed by a single surgeon, the first author. ORIF was performedthrough a medial approach, with interfragmentary screws andapplication of a distal tibial anatomical neutralisation plates. Theanterolateral fragment was fixed percutaneously with a lag screwunder image intensifier control. A K-wire was inserted into thefragment to assist in manipulation and reduction of fracture frag-ment. EFLIF was achieved by stabilisation of the fibula first to restorelength and alignment and to provide stability to tibial fracture,through a lateral approach by means of plate or K-wire. Closedtechnique for fracture reduction was carried out for all cases exceptfour cases, where restoration of the ankle joint could not be achievedexcept with minimal open reduction. The closed technique of frac-ture reduction was initiated by ankle distraction by the tractionconstruct, utilising constrained circular external fixator. The fixatorconsisted of two rings; the proximal was the tibial block, and afloating ring at the level of the ankle joint. The nuts securing thedistal tibial ring to the threaded rods were loosened so the ring canbe manipulated up or down, and a foot plate transfixing the anklejoint was mounted over the calcaneus. The frame is then checked inthe frontal and sagittal planes after distraction and reduction offracture by ligamentotaxis. Some important technical aspects of bothtreatment groups are demonstrated in (Figures 1 and 2).

Patients were instructed 6 weeks of nonweight bearing. Afterremoval of the foot plate, partial weight bearing was started withearly active mobilisation of the ankle and subtalar joints. Astandardised physiotherapy rehabilitation regimen was thenimplemented.

Outcome measures

We used the American Orthopaedic Foot and Ankle Society scoreas a standard method of reporting clinical status of the ankle andhindfoot.13 The system incorporates both subjective and objectivefactors into numerical scales to describe pain, function and align-ment. It has been widely used in studies of foot and ankle surgery,including a large multicentre clinical trial.14 Ankle range of motionwas measured with a goniometer with the knee fully extended.Patient-reported outcomes were gathered at 12 and 18 months. Wemeasured the primary outcome at 2 years postoperative when mostpatients would be expected to have reached maximal recovery.Objective and subjective clinical parameters were recorded by asingle orthopaedic surgeon, who was unaware of treatment alloca-tion. Patients were evaluated radiologically immediately post-operative, at 12 and 18 months and 2 years by serial anteroposteriorand lateral X-rays of foot and ankle (Figure 3AeC).

Figure 1. (AeD) An example of a Rüedi and Allg€ower type III injury managed by open reduction internal fixation utilising a distal tibial anatomical neutralisation plate and fibularplating. Note the anatomic fixation of the displaced anterolateral tibial fragment by a percutaneous interfragmentary screw taken through a separate incision.

A. Rayan et al. / Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e8986

Statistical analysis

Data were coded, entered and processed on a personal com-puter using SPSS software version 21. The cut-off value for signifi-cance was set at p < 0.05. Student t test was used to assess the

statistical significance of the difference between two populationmeans involving independent samples. Analysis of variancetest was used to evaluate the equality of several groupmeans, and itwas used to test the difference about mean values of some pa-rameters among multiple groups. Paired t-test was used to assess

Figure 2. (AeC). An example of a Rüedi and Allg€ower type III injury managed by bridging external fixation with limited internal fixation. Note the limited internal fixation of thetibial fracture through K-wires. (B) Notice also the fibular fixation in this case was achieved by intramedullary K-wires because of poor skin condition. (C) The immediate post-operative ring fixator construct is depicted.

A. Rayan et al. / Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e89 87

the statistical significance of the difference between two popula-tion means involving matched or paired samples.

Results

In general, the results of ORIF and EFLIF in treatment of high-energy pilon fractures were equally effective in terms of func-tional and radiologic outcomes and complication rates at the finalfollow-up. Patient characteristics and radioclinical results withcomplications are depicted in (Tables 1 and 2).

Discussion

The optimal treatment for high-energy pilon fractures remainscontroversial. Numerous retrospective studies comparing out-comes of ORIF and EFLIF in high-energy fractures have been con-ducted.1,12,15,16 Nonetheless in interpreting the data from registry-based and institutional series, the shortcomings of retrospectiveanalyses must be considered. These shortcomings include patient,surgeon and treatment selection biases. For example, retrospective

studies where ORIF was associated with fewer complications andless posttraumatic arthritis, when comparedwith EFLIF, may reflecta selection bias for open injuries and more severely comminutedfractures to be managed with EFLIF.16,17 Other retrospective studieshave reported comparable outcomes between ORIF and EFLIF withrespect tomechanism of injury, presence of openwounds as well asage and functional outcomes.2,15 Nevertheless other comparativeretrospective studies demonstrated that functional scores weresignificantly related to the quality of reduction independent fromtype of surgery. Poor functional scores were found independentfrom the type of surgery and quality of reduction in Rüedi andAllg€ower type II and III fractures.1 Because the outcome after sur-gical treatment of tibia pilon fractures is dependent on multiplefactors in general and in retrospective studies in specific, it isincreasingly difficult to isolate and evaluate the potential variablesthat are known to affect the treatment outcome and to generaliseresearch conclusions of such studies.1,2,15,16

Well-designed and well-implemented prospective studies helpto avoid or minimise bias in research as outcome is unknown attime of enrolment. Hence, we conducted a two matched group,

Figure 3. Plain X-ray anteroposterior and lateral pilon fracture Allg€ower type III injury managed by bridging external fixation. (A) Immediate postoperative; (B) 2 months post-operative; (C) 6 months postoperative after removal of external fixation.

Table 1Demographic data.

Parameter ORIF EFLIF

Number 22 20Mean age 31.3 ± 9.4 33.8 ± 6.4Gender (male:female) 14:8 13:7Days to operation 9.3 9.4Follow-up (mo) 20.4 19.9Operative time (min) 137.3 98.7Healing time (d) 112.9 98Rüedi and Allg€ower subtype (II:III) 12:10 6:14Tscherne classification (I:II) 12:10 7:13Mode of injury (axial loading:twisting) 14:8 8: 12

EFLIF ¼ external fixation with limited internal fixation; ORIF ¼ open reduction andinternal fixation.

Table 2Clinical results.

Parameter ORIF EFIF p Value

AOFAS score 82.3 86.7 0.3ComplicationsMaluniona 2 2Nonunion 0 0Arthritic symptoms 2 2

AOFAS ¼ American Orthopaedic Foot and Ankle Society; EFLIF ¼ external fixa-tion with limited internal fixation; ORIF ¼ open reduction and internal fixation.

a Malunion is defined as coronal plane deviation >10� , bolded p value indicatestatistical significance.

A. Rayan et al. / Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e8988

assessor-blinded “prospective” randomised clinical studycomparing the results of ORIF to that of EFLIF. Schul and Grimesstated that trials with inadequate or unclear randomisation tendedto overestimate treatment effects up to 40% compared with thosethat used proper randomisation.18 We aimed to avoid creation ofsystematically different treatment groups that may influence theoutcome of the surgical intervention. We therefore employedrigorous criteria in patient selection and allocation to either treat-ment groups. Additionally, we used adaptive minimisation toassign patients to treatment groups with respect to some prog-nostic factors such as smoking, Rüedi and Allg€ower type and soft

tissue injury severity. To minimise performance bias, the authorsassigned the surgical procedures to a single surgeon, used objectiveassessment tools with moderate interobserver and intraobserveragreement on Oestern and Tscherne classification and imple-mented validated rating scales such as American Orthopaedic Footand Ankle Society scale. The authors consider the previous factorsas an obvious strength of the present study. Nonetheless, the Rüediand Allg€ower system has been shown to have a low interobserverreliability, and debate still exists regarding whether the system hasprognostic value or not.19 In the present study, we did nt assess theobserver reliability of that system. We considered this to be one ofthe limitations of the study.

We are aware of only one randomised, prospective study tocompare the results of ORIF and EFLIF in tibial plafond fractures.9

Wyrsch and colleagues concluded that external fixation is a satis-factorymethod of treatment for fractures of the tibial plafond and isassociated with fewer complications than internal fixation.9 Theprevious results are discordant with our results that reportedcomparable outcomes between the two groups with respect tofunctional and radiologic outcomes and complication rates.Nevertheless the conclusions of Wyrsch and colleagues9 should beinterpreted with extreme caution. Their study included non-displaced Rüedi and Allg€ower type I pilon fractures in addition tohigh-energy types II and III, and the EFLIF group included 10 openfractures. These factors among others create a degree of imbalancebetween treatment groups and may be a potential source of biasthat should to be considered when understanding outcomes.Noteworthy is that they reported that the low clinical scoressignificantly correlated to the severity of fracture comminutionirrespective of treatment type, an observation that has beenconsistently reported by various authors including ourstudy.1,6,9,16,17,20

In conclusion, both ORIF and EFLIF as treatment options in thetreatment of high-energy pilon fractures are equally effective interms of functional and radiologic outcomes and complication rateson the short term. Soft tissue integrity and fracture comminutionseem to have a significant influence on outcomes of intervention.Well-designed and well-implemented randomised prospectivestudies aid in reducing the bias. Residual and potential sources ofbias need to be addressed when interpreting the results and

A. Rayan et al. / Journal of Orthopaedics, Trauma and Rehabilitation 24 (2018) 84e89 89

generalising conclusions. A prospective multicentre study with alarger sample size that controls for other associated variables andcomorbidities is warranted.

Conflicts of interest

The authors of the present study declare that there are noconflicts of interest and no financing was received for research onwhich the study is based.

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