Open reduction internal fixation versus external

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

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Original Article

Open reduction internal fixation versus external fixation with limited internal fixation for displaced comminuted closed pilon fractures: A randomised 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 Mahmoud Department of Orthopaedic Surgery, Faculty of Medicine, Ain-Shams University, 38 Abbasia, Cairo, Egypt

a r t i c l e i n f o

a b s t r a c t

Article history: Received 11 February 2017 Received in revised form 9 June 2017 Accepted 1 August 2017

Background: Pilon fractures involve the dome of the distal tibial articular surface. The optimal treatment for high-energy pilon fractures remains controversial. Some authors advocate the use of open reduction and internal fixation (ORIF) to avoid articular incongruence. Others advocate the use of bridging external fixation with limited internal fixation (EFLIF) to reduce soft tissue complications. Literature reports of prospective studies comparing the radioclinical outcomes of ORIF and EFLIF in high-energy fractures are scarce. Retrospective studies have their limitations because of insufficient randomisation. The objective of this randomised prospective study is to compare the clinical, radiologic and functional outcomes of displaced and €wer type II and III, treated by either ORIF or EFLIF. comminuted closed pilon fractures, Rüedi and Allgo Materials and methods: Forty-two patients were selected for the study. Twenty-two patients were subjected to ORIF and 20 patients were subjected to EFLIF. We used the American Orthopaedic Foot and Ankle Society score as a standard method of reporting clinical status of the ankle. Patients were followedup 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 in terms of functional outcomes and complication rates on the short term. Conclusion: Soft tissue integrity and fracture comminution seem to have a significant influence on outcomes of intervention. A prospective multicentre study with a larger sample size that controls for other associated variables and comorbidities is warranted. Level of evidence: Level II.

Keywords: external fixation internal fixation intraarticular ankle fractures prospective tibial plafond

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

* Corresponding author. Department of Orthopaedic Surgery, Faculty of Medicine, Ain-Shams University, 38 Abbasia, Cairo, Egypt. E-mail: [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected]. https://doi.org/10.1016/j.jotr.2017.08.001 2210-4917/Copyright © 2018, Hong Kong Orthopaedic Association and the Hong Kong College of Orthopaedic Surgeons. Published by Elsevier (Singapore) Pte Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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

Introduction Pilon fractures involve the dome of the distal tibial articular surface and extend into the adjacent metaphysis. They are relatively rare fractures ranging from low- to high-energy injuries. The low-energy rotational injuries have been shown to have excellent functional results with open reduction and internal fixation (ORIF). The highenergy axial-loading injuries have had uniformly moderate results and higher complication rates.1 These can be challenging to manage because of the usual high-energy involved and the limited soft tissue envelope that surrounds the distal tibia. The condition of the soft tissues is crucial with respect to timing of definitive surgery and method of surgical fixation. Poor timing is associated with poor outcomes. Soft tissues must be ready for the second insult dealt by surgery.2e4 Additional treatment outcomes vary depending on multiple factors such as degree of bony comminution, quality of reduction, the surgeon's experience and associated injuries. Therefore, the optimal treatment for high-energy pilon fractures remains controversial. Some authors advocate the use of ORIF to avoid articular incongruence and consequent posttraumatic arthritis and to maximise long-term results.1,5,6 Others advocate the use of bridging external fixation with limited internal fixation (EFLIF) in high-energy fractures to reduce soft tissue-related complications and blood loss.2,7 Proponents of the EFLIF may argue that the necessity for an anatomical restoration of the articular surface is controversial and does not always correlate with the clinical outcome.8 Literature reports of prospective studies comparing between the radioclinical outcomes of ORIF and EFLIF in high-energy fractures are scarce.9 This inspired us to set up a prospective study to compare the clinical, radiologic and functional outcomes of displaced and comminuted € wer type II and III,10 treated by closed pilon fractures, Rüedi and Allgo either ORIF or EFLIF. The authors declare that no conflict of interest exists. No financing was received for this study. The local ethical committee authorised conducting this study. Patients and methods We carried out a two matched group, assessor-blinded prospective randomised clinical study comparing the results of ORIF to that of EFLIF for closed displaced pilon fractures, Rüedi and €wer type II and III. The study was conducted during the period Allgo from February 2010 to December 2012. Patients were followed-up for over 2 years after the surgical treatment. Patient selection and randomisation A total of 45 patients were randomised to the study. One patient refused treatment. Two patientsdone to each groupdwere randomised, and they received planned treatment but dropped out. They had insufficient follow-up and incomplete data to be included and analysed for the results. Therefore, 42 patients were selected for the study. Twenty-two patients were subjected to ORIF (Group I), 14 males and eight females in that group. Twenty patients were subjected to EFLIF (Group II), 13 males and seven females, and the study was conducted at the authors' institution. Patients were explained about the study, and written consent was obtained. Patients were eligible if they were aged 18 years or more, with a recent (less than 3 weeks) closed intraarticular displaced distal € wer type II and III. Exclusion tibial fractures of Rüedi and Allgo criteria were other serious leg injuries sufficient to affect outcome at 2 years such as peripheral angiopathy, neuropathy in the injured limb, multiple fractures, morbid obesity and compartment syndrome. We included patients with bilateral fractures provided that both of the fractures met the inclusion criteria. Patients who consented to participate were randomised by flipping a coin 1:1 to

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receive either ORIF or EFLIF. We used adaptive minimisation to avoid development of significant differences between the two groups in some prognostic factors such as smoking status, Rüedi €wer type fractures, and soft tissue injury severity. Bilateral and Allgo fractures 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 posterior slab. Patients were subjected to plain radiographs, including anteroposterior, mortise and lateral views centred over the ankle and full-length radiographs of the leg including the knee and ankle. Targeted X-ray examinations were conducted on other areas depending on clinical findings. Additionally, patients were routinely subjected to computed tomography of the distal tibia and ankle joint. Soft tissue injury severity was assessed according to Oestern and Tscherne classification.11 The classification has demonstrated an adequate level of intraobserver and interobserver agreement in tibial plateau and tibial pilon fractures.12 Surgical interventions were performed by a single surgeon, the first author. ORIF was performed through a medial approach, with interfragmentary screws and application of a distal tibial anatomical neutralisation plates. The anterolateral fragment was fixed percutaneously with a lag screw under image intensifier control. A K-wire was inserted into the fragment to assist in manipulation and reduction of fracture fragment. EFLIF was achieved by stabilisation of the fibula first to restore length and alignment and to provide stability to tibial fracture, through a lateral approach by means of plate or K-wire. Closed technique for fracture reduction was carried out for all cases except four cases, where restoration of the ankle joint could not be achieved except with minimal open reduction. The closed technique of fracture reduction was initiated by ankle distraction by the traction construct, utilising constrained circular external fixator. The fixator consisted of two rings; the proximal was the tibial block, and a floating ring at the level of the ankle joint. The nuts securing the distal tibial ring to the threaded rods were loosened so the ring can be manipulated up or down, and a foot plate transfixing the ankle joint was mounted over the calcaneus. The frame is then checked in the frontal and sagittal planes after distraction and reduction of fracture by ligamentotaxis. Some important technical aspects of both treatment groups are demonstrated in (Figures 1 and 2). Patients were instructed 6 weeks of nonweight bearing. After removal of the foot plate, partial weight bearing was started with early active mobilisation of the ankle and subtalar joints. A standardised physiotherapy rehabilitation regimen was then implemented. Outcome measures We used the American Orthopaedic Foot and Ankle Society score as a standard method of reporting clinical status of the ankle and hindfoot.13 The system incorporates both subjective and objective factors into numerical scales to describe pain, function and alignment. It has been widely used in studies of foot and ankle surgery, including a large multicentre clinical trial.14 Ankle range of motion was measured with a goniometer with the knee fully extended. Patient-reported outcomes were gathered at 12 and 18 months. We measured the primary outcome at 2 years postoperative when most patients would be expected to have reached maximal recovery. Objective and subjective clinical parameters were recorded by a single orthopaedic surgeon, who was unaware of treatment allocation. Patients were evaluated radiologically immediately postoperative, at 12 and 18 months and 2 years by serial anteroposterior and lateral X-rays of foot and ankle (Figure 3AeC).

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

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

statistical significance of the difference between two population means involving independent samples. Analysis of variance test was used to evaluate the equality of several group means, and it was used to test the difference about mean values of some parameters among multiple groups. Paired t-test was used to assess


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€ wer type III injury managed by bridging external fixation with limited internal fixation. Note the limited internal fixation of the Figure 2. (AeC). An example of a Rüedi and Allgo tibial 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 postoperative ring fixator construct is depicted.

the statistical significance of the difference between two population means involving matched or paired samples. Results In general, the results of ORIF and EFLIF in treatment of highenergy pilon fractures were equally effective in terms of functional and radiologic outcomes and complication rates at the final follow-up. Patient characteristics and radioclinical results with complications are depicted in (Tables 1 and 2). Discussion The optimal treatment for high-energy pilon fractures remains controversial. Numerous retrospective studies comparing outcomes of ORIF and EFLIF in high-energy fractures have been conducted.1,12,15,16 Nonetheless in interpreting the data from registrybased and institutional series, the shortcomings of retrospective analyses must be considered. These shortcomings include patient, surgeon and treatment selection biases. For example, retrospective

studies where ORIF was associated with fewer complications and less posttraumatic arthritis, when compared with EFLIF, may reflect a selection bias for open injuries and more severely comminuted fractures to be managed with EFLIF.16,17 Other retrospective studies have reported comparable outcomes between ORIF and EFLIF with respect to mechanism of injury, presence of open wounds as well as age and functional outcomes.2,15 Nevertheless other comparative retrospective studies demonstrated that functional scores were significantly related to the quality of reduction independent from type of surgery. Poor functional scores were found independent from the type of surgery and quality of reduction in Rüedi and € wer type II and III fractures.1 Because the outcome after surAllgo gical treatment of tibia pilon fractures is dependent on multiple factors in general and in retrospective studies in specific, it is increasingly difficult to isolate and evaluate the potential variables that are known to affect the treatment outcome and to generalise research conclusions of such studies.1,2,15,16 Well-designed and well-implemented prospective studies help to avoid or minimise bias in research as outcome is unknown at time of enrolment. Hence, we conducted a two matched group,

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

Table 1 Demographic data. Parameter

ORIF

EFLIF

Number Mean age Gender (male:female) Days to operation Follow-up (mo) Operative time (min) Healing time (d) €wer subtype (II:III) Rüedi and Allgo Tscherne classification (I:II) Mode of injury (axial loading:twisting)

22 31.3 ± 9.4 14:8 9.3 20.4 137.3 112.9 12:10 12:10 14:8

20 33.8 ± 6.4 13:7 9.4 19.9 98.7 98 6:14 7:13 8: 12

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

Table 2 Clinical results. Parameter

ORIF

EFIF

p Value

AOFAS score Complications Maluniona Nonunion Arthritic symptoms

82.3

86.7

0.3

2 0 2

2 0 2

AOFAS ¼ American Orthopaedic Foot and Ankle Society; EFLIF ¼ external fixation with limited internal fixation; ORIF ¼ open reduction and internal fixation. a Malunion is defined as coronal plane deviation >10 , bolded p value indicate statistical significance.

assessor-blinded “prospective” randomised clinical study comparing the results of ORIF to that of EFLIF. Schul and Grimes stated that trials with inadequate or unclear randomisation tended to overestimate treatment effects up to 40% compared with those that used proper randomisation.18 We aimed to avoid creation of systematically different treatment groups that may influence the outcome of the surgical intervention. We therefore employed rigorous criteria in patient selection and allocation to either treatment groups. Additionally, we used adaptive minimisation to assign patients to treatment groups with respect to some prog€ wer type and soft nostic factors such as smoking, Rüedi and Allgo

tissue injury severity. To minimise performance bias, the authors assigned the surgical procedures to a single surgeon, used objective assessment tools with moderate interobserver and intraobserver agreement on Oestern and Tscherne classification and implemented validated rating scales such as American Orthopaedic Foot and Ankle Society scale. The authors consider the previous factors as an obvious strength of the present study. Nonetheless, the Rüedi €wer system has been shown to have a low interobserver and Allgo reliability, and debate still exists regarding whether the system has prognostic value or not.19 In the present study, we did nt assess the observer reliability of that system. We considered this to be one of the limitations of the study. We are aware of only one randomised, prospective study to compare the results of ORIF and EFLIF in tibial plafond fractures.9 Wyrsch and colleagues concluded that external fixation is a satisfactory method of treatment for fractures of the tibial plafond and is associated with fewer complications than internal fixation.9 The previous results are discordant with our results that reported comparable outcomes between the two groups with respect to functional and radiologic outcomes and complication rates. Nevertheless the conclusions of Wyrsch and colleagues9 should be interpreted with extreme caution. Their study included non€wer type I pilon fractures in addition to displaced Rüedi and Allgo high-energy types II and III, and the EFLIF group included 10 open fractures. These factors among others create a degree of imbalance between treatment groups and may be a potential source of bias that should to be considered when understanding outcomes. Noteworthy is that they reported that the low clinical scores significantly correlated to the severity of fracture comminution irrespective of treatment type, an observation that has been consistently reported by various authors including our study.1,6,9,16,17,20 In conclusion, both ORIF and EFLIF as treatment options in the treatment of high-energy pilon fractures are equally effective in terms of functional and radiologic outcomes and complication rates on the short term. Soft tissue integrity and fracture comminution seem to have a significant influence on outcomes of intervention. Well-designed and well-implemented randomised prospective studies aid in reducing the bias. Residual and potential sources of bias need to be addressed when interpreting the results and


generalising conclusions. A prospective multicentre study with a larger sample size that controls for other associated variables and comorbidities is warranted. Conflicts of interest The authors of the present study declare that there are no conflicts of interest and no financing was received for research on which the study is based. References lu C, Sarıdog an K. The analysis of the 1. Korkmaz A, Ciftdemir M, Ozcan M, Copurog variables, affecting outcome in surgically treated tibia pilon fractured patients. Injury 2013 Oct;44(10):1270e4. https://doi.org/10.1016/j.injury.2013.06.016. 2. Davidovitch RI, Elkhechen RJ, Romo S, Walsh M, Egol KA. Open reduction with internal fixation versus limited internal fixation and external fixation for high grade pilon fractures (OTA type 43C). Foot Ankle Int 2011 Oct;32(10):955e61. 3. Amorosa LF, Brown GD, Greisberg J. A surgical approach to posterior pilon fractures. J Orthop Trauma 2010 Mar;24(3):188e93. 4. Sirkin M, Sanders R, DiPasquale T, Herscovici Jr D. A staged protocol for soft tissue management in the treatment of complex pilon fractures. J Orthop Trauma 2004 Sep;18(8 Suppl.):S32e8. 5. Conroy J, Agarwal M, Giannoudis PV, Matthews SJ. Early internal fixation and soft tissue cover of severe open tibial pilon fractures. Int Orthop 2003;27:343e7. 6. Egol KA, Wolinsky P, Koval KJ. Open reduction and internal fixation of tibial pilon fractures. Foot Ankle Clin 2000 Dec;5(4):873e85. 7. Dickson KF, Montgomery S, Field J. High energy plafond fractures treated by a spanning external fixator initially and followed by a second stage open reduction internal fixation of the articular surfaceepreliminary report. Injury 2001 Dec;32(Suppl. 4):SD92e8. 8. Marsh JL, Weigel DP, Dirschl DR. Tibial plafond fractures. How do these ankles function over time? J Bone Joint Surg Am 2003;85-A(2):287e95.

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