Fate of the syndesmotic screw—Search for a prudent solution

Fate of the syndesmotic screw—Search for a prudent solution

G Model JINJ-6470; No. of Pages 5 Injury, Int. J. Care Injured xxx (2015) xxx–xxx Contents lists available at ScienceDirect Injury journal homepage...

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G Model

JINJ-6470; No. of Pages 5 Injury, Int. J. Care Injured xxx (2015) xxx–xxx

Contents lists available at ScienceDirect

Injury journal homepage: www.elsevier.com/locate/injury

Fate of the syndesmotic screw—Search for a prudent solution Igor Kaftandziev a,*, Marko Spasov a, Simon Trpeski a, Beti Zafirova-Ivanovska b, Bore Bakota c a

University Clinic of Traumatology, Medical Faculty of Skopje, Skopje, Macedonia Institute of Epidemiology and Biostatistics, Medical Faculty of Skopje, Skopje, Macedonia c Orthopaedics and Traumatology Department, Our Lady of Lourdes Hospital, Drogheda, Louth, Ireland b

A R T I C L E I N F O

A B S T R A C T

Keywords: Ankle fracture Syndesmosis Syndesmotic screw Removal Functional outcome

Introduction: Ankle fractures are common injuries. Since the recognition of the importance of syndesmotic injury in ankle fractures, much of the scientific work has been focused on concomitant syndesmotic injury. Despite the invention of novel devices for restoration and maintenance of the congruent syndesmosis following syndesmotic injury, the metallic syndesmotic screw is still considered to be the ‘‘gold standard’’. The aim of this study was to compare the clinical results in patients who retained the syndesmosis screw with those in whom the screw was removed following open reduction and internal fixation of the malleolar fracture associated with syndesmosis disruption. Materials and methods: This was a retrospective study of 82 patients. Minimum follow-up was 12 months. Clinical evaluation included American Orthopaedic Foot and Ankle Society (AOFAS) score and Visual Analogue Scale (VAS) for patient general satisfaction. The condition of the screw (removed, intact or broken), presence of radiolucency around the syndesmotic screw and the tibiofibular clear space were recorded using final follow-up radiographs. Results: Three cortices were engaged in 66 patients (80%) and quadricortical fixation was performed in the remaining 16 patients (20%). The number of engaged cortices did not correlate with the clinical outcome and screw fracture. A single syndesmotic screw was used in 71 patients (86%. The mean AOFAS score in the group with intact screw (I) was 83; the scores in the group with broken screw (B) and removed screw (R) were 92.5 and 85.5, respectively. There was a statistically significant difference between the three groups: this was due to the difference between groups I and B; the difference between groups I and R and groups B and R were not statistically significant. There were no statistically significant differences in VAS results. Conclusion: There were no statistically significant differences in clinical outcome between the group with the screw retained and the group in which the screw was removed; however, the group with broken screws had the best clinical outcome based on AOFAS score. Widening of the syndesmosis after screw removal was not evident. We do not recommend routine syndesmosis screw removal. ß 2015 Elsevier Ltd. All rights reserved.

Introduction Ankle fractures are common injuries, accounting for 9% of all fractures [1], and represent the most common intraarticular fracture of the weight-bearing joint [2]. During the past decades, there has been a three-fold increase in the incidence of ankle fracture in elderly females [3], which makes these injuries even

* Corresponding author. Tel.: +389 72 222 898. E-mail address: [email protected] (I. Kaftandziev).

more of a challenge. Approximately 23% of ankle fractures are thought to be associated with injury to the distal tibiofibular syndesmosis [4]. Widening of the ankle mortise by 1 mm decreases the contact area of the tibiotalar joint by 42%, which leads to joint instability and early osteoarthritis [5]. Subsequently, much of the scientific work regarding ankle fractures has been focused on the concomitant injury to the syndesmosis. Tibiofibular transfixation is a mandatory step in cases of syndesmotic instability after malleolar fracture repair [6]. Although syndesmotic disruption is essentially ligamentous injury, the standard treatment is not focused on ligamentous

http://dx.doi.org/10.1016/j.injury.2015.10.062 0020–1383/ß 2015 Elsevier Ltd. All rights reserved.

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repair, but on placement of the positioning syndesmotic screw. Despite the invention of novel devices for restoration and maintenance of the congruent mortise (bioabsorbable screws, suture-button device) [7,8], application of the metallic syndesmotic screw is still considered the ‘‘gold standard’’ [9– 12]. However, although the strength of fixation stabilises the joint, it eliminates the normal motion between the tibia and fibula. A cadaver study showed that there is a significant limitation of the fibula relative to the tibia in the presence of the syndesmotic screw [13] and confirmed the findings of a biomechanical study by Needleman [14]. Although there is no doubt of the contribution of the discrete tibiofibular motion in the normal biomechanics of the ankle [15,16], the clinical importance of syndesmotic screw removal after a certain time and its effect on clinical outcome is still obscure [17,18]. Current scientific knowledge does not offer a definitive solution for the fate of the syndesmosis screw and many practising surgeons just follow expert opinion. The aim of this study was to compare the clinical results in patients who retained the syndesmosis screw with those in whom the screw was removed following open reduction and internal fixation of the malleolar fracture associated with syndesmosis disruption.

According to hospital postoperative protocol, routine follow-up was undertaken at 4 weeks, 10 weeks, 3 months, 6 months and 12 months postoperatively. Clinical review A total of 136 patients who met the enrolment criteria were sent a letter in which the nature of the study was explained and the date and time of outpatient clinic check-up was proposed. Eightytwo of these patients (60%) agreed to take part in the study and returned for a formal clinical and radiological examination. Minimum follow-up was 12 months post index procedure. Clinical evaluation included the American Orthopaedic Foot and Ankle Society (AOFAS) score and Visual Analogue Scale (VAS) for patient general satisfaction with outcome regarding their injury (10 points denotes maximal satisfaction). AOFAS score consists of nine questions subdivided into three categories: pain, function and alignment. The best possible score is 100 points. The patients completed all the questions, apart from those that related to alignment and range of motion, which were completed by the surgeon. The patients in which the syndesmosis screw was retained were also assessed for tenderness over the screw. Radiological review

Materials and methods The institutional review board approved the study before any patients were enrolled. Patients who underwent syndesmotic screw fixation from January 2011 to December 2012 were identified from a patient information database at the university hospital. Patients were excluded from the study if their charts or radiographs were unavailable or incomplete. Inclusion was limited to patients who had undergone open reduction and internal fixation of the ankle fracture with screw fixation of the disrupted syndesmosis that was confirmed at the operation. Exclusion criteria were postoperative infection, postoperative hardware failure, additional surgery due to postoperative complications, delayed syndesmosis repair, open fracture, direct crush injury and age under 18 years. Patients in whom the syndesmotic screw was retained because of advanced age, limited mobility or sedentary lifestyle were also excluded. Patient characteristics (age, sex), mechanism of injury (low energy trauma, high energy trauma), fracture characteristics (affected side, fracture type according to AO/Weber classification, number of fractured malleoli) and surgical characteristics (screw diameter, number of screws, trior quadricortical placement and time of screw removal) were extracted from the database and reviewed. Surgery was performed during the first 6 h after injury. Internal fixation was conducted according to AO principles, using a onethird tubular plate for fibula fracture and either one or two 4.0 mm cancellous screws for medial malleolar fracture. Syndesmotic injury, if not obvious, was tested using the hook test under intraoperative fluoroscopy and subsequently reduced and fixed with either one or two 3.5 mm cortical screws. Reduction of the fibula into the incisura fibularis was checked in both anteroposterior and profile views and the positioning screw placed through the plate hole at a dorsal angle of 308, 2.5 to 4 cm above the syndesmosis with the ankle in dorsiflexion to avoid undue compression of the joint. The postoperative protocol consisted of splint application for 10 to 14 days. After removal of the stitches, partial-weight bearing was allowed for 6 weeks, then additional weight-bearing for another 2 weeks and full weight-bearing after 8 weeks. Syndesmotic screw was removed at 8 to 12 weeks post injury, depending on individual surgeon preference. Single dose antibiotic prophylaxis and thromboprophylaxis were given for 6 weeks post injury.

Anteroposterior, lateral and mortise view radiographs were ordered as part of final follow-up. The condition of the screw (intact or broken), presence of radiolucency around the syndesmosis screw and the tibiofibular clear space were recorded. Statistical analysis All data (demographics, injury classification, mechanism of injury and time of surgery) extracted from the database and collected during the final outpatient clinic examination were entered into a database (Microsoft Excel). Descriptive statistics (mean, median, SD, percentage) were calculated. Non-parametric tests (Kruskal–Wallis and Mann–Whitney U) were used to compare the distributions of the defined groups of patients. Statistical analysis was undertaken using SPSS for Windows, version 18.0. Statistical significance was defined as p value of <0.05. Results A total of 82 patients took part in the study (attendance rate 60%). Fifty-four patients (66%) were male and 28 (34%) were female. Mean age at the time of injury was 49 years (range 19 to 71 years). Immediate post-injury radiographs extracted from the hospital database were used for fracture classification. Thirtythree patients sustained Danis–Weber B type fractures; the remaining patients had Danis–Weber C fractures. Based on the state of the syndesmosis screw, the patients were separated into three groups: group I (intact screw) comprised 46 patients (56%), group R (removed) included 23 patients (28%) and group B (broken) contained the remaining 13 patients (16%). There were no statistically significant differences in demographic features between the three defined groups. Radiological outcome Fully threaded 3.5 mm stainless steel screws were used in all patients to fix the injured syndesmosis. In 66 patients (80%), three cortices were engaged and in the other 16 patients (20%) quadricortical fixation was performed. The distribution of tricortical and quadricortical fixation in all three groups was almost

Please cite this article in press as: Kaftandziev I, et al. Fate of the syndesmotic screw—Search for a prudent solution. Injury (2015), http:// dx.doi.org/10.1016/j.injury.2015.10.062

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JINJ-6470; No. of Pages 5 I. Kaftandziev et al. / Injury, Int. J. Care Injured xxx (2015) xxx–xxx Table 1 American Orthopaedic Foot and Ankle Society (AOFAS) scores divided by groups (N—number; med—median; min—minimum; max—maximum; SD—standard deviation).

Table 3 Overall patient satisfaction measured with VAS (N—number; med—median; min— minimum; max—maximum; SD—standard deviation). Descriptive statistics, VAS

Descriptive statistics, AOFAS

Group I Group R Group B

N

Mean

Med

Min

Max

SD

46 23 13

83 85.5 92.5

84.5 84 94

55 68 97

100 100 100

12.2 11.6 6.02

3

Group I Group R Group B

N

Mean

Med

Min

Max

SD

46 23 13

8.43 8.78 8.92

8.5 9 9

5 6 7

10 10 10

1.2 1 1.1

Kruskal–Wallis test: H (2, N = 82) = 2.15 p = 0.34; p > 0.05.

Kruskal–Wallis test: H (2, N = 82) = 6.006 p = 0.0496; p < 0.05.

Table 2 Results of non-parametric Mann–Whitney U test demonstrating statistically significant difference in AOFAS score between group I and group B. Mann–Whitney U test; AOFAS score

Group I/B Group I/R Group B/R

Z

p Value

2.55 0.69 1.43

0.01; p < 0.05 0.48; p > 0.05 0.15; p > 0.05

equal. The number of engaged cortices did not correlate with the clinical outcome and screw fracture. A single syndesmotic screw was used In 71 patients (86%). The decision whether to use one or two syndesmotic screws was made by the operating surgeon and based upon the severity of injury to the syndesmosis. There was no widening of the syndesmosis in the patients in whom the screw was broken or removed. A total of 39 (66%) of the 59 patients who retained an intact or broken screw had radiolucency around the screw on the final follow-up radiograph. There was no statistically significant difference in AOFAS scores and VAS score in the patients with radiolucency compared with those with no radiolucency. Clinical outcome Table 1 presents the results of descriptive statistics for AOFAS score. The mean AOFAS score in group I was 83, in group B was

92.5 and in group R was 85.5. There was a statistically significant difference among the three groups (Kruskal–Wallis test: H (2, N = 82) = 6.006 p = 0.0496 p < 0.05). Testing the difference among the three groups separately showed that the significance was due to the differences between groups I and B; the difference between groups I and R and groups B and R were not statistically significant (Table 2). Statistical analysis of VAS results did not show statistically significant differences in overall patient satisfaction related to their injury (Kruskal–Wallis test: H (2, N = 82) = 2.15 p = 0.34; p > 0.05). The results are shown in Table 3. Discussion Ankle fractures with associated syndesmosis injury are common injuries [19]. This retrospective study presented 82 patients with ankle fracture associated with syndesmosis injury. The results showed that there was no statistically significant difference in clinical outcome between patients in whom the screw was removed and those in whom the screw was intact. Figs. 1 and 2 present the radiographs of patients who belong to group I and group R, respectively, and had similar fracture pattern and demographics. Although treatment regarding the syndesmosis screw was different, they both had similar clinical outcome. However, there was a statistically significant difference between the group in which the screw was left in place indefinitely and the group in which the screw was broken.

Fig. 1. Early postoperative (left) and final follow-up (right) radiographs of a patient in whom the syndesmotic screw has been removed.

Fig. 2. Preoperative radiograph (left) and final follow-up radiograph (right) of a patient with retained screw.

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Fig. 3. Preoperative (left), early postoperative (middle) and final follow-up radiographs of a patient with radiolucency around the syndesmotic screw.

Despite considerable scientific research, the need for routine removal of the syndesmotic screw is still the subject of debate. Rigid fixation of the distal tibiofibular syndesmosis limits the motion of the fibula in relation to the tibia during normal ankle motion. A recent cadaver study by Huber et al. [13] analysed the motion of the fibula in relation to the tibia on the specimens in which the syndesmosis was dissected and subsequently fixed with one 3.5 mm diameter tricortical or quadricortical screw, or two 3.5 mm diameter quadricortical screws. Their results showed that syndesmosis screw reduced the horizontal, sagittal and axial rotation of the fibula relative to the tibia. They recommended syndesmosis screw removal before full weight-bearing to enable physiological movements of the fibula relative to the tibia. Another study, published in 1989, that used 4.2 mm syndesmosis screws on cadaveric models showed similar results and recommended screw removal prior to full activity [14]. The study by Manjoo et al., in which symptomatic screw removal policy was followed, showed slightly worse functional outcome in patients with intact screws compared with those with broken, loosened or removed screws [20]. However, they also emphasised the certain disadvantages of routine screw removal, including risk for redisplacement, need for secondary surgery and patient reluctance. In addition, reference books in skeletal trauma still recommend syndesmosis screw removal before weight-bearing [21,22], and a Dutch nationwide survey [23] showed that routine syndesmotic screw removal was conducted by 87% of the surgeons. Other clinical studies do not support these findings. The retrospective study of Schepers et al. did not show statistically significant effect on overall outcome in a group with screws removed within 8 weeks postinjury compared with groups with delayed removal and the screws left in place [24]. Another literature review showed no difference in clinical outcome between patients with retained or removed screws and suggested removal of intact screws in cases of hardware irritation and limited range of motion after 4 to 6 months [25]. Our study does not support routine removal of the syndesmosis screw. AOFAS scores showed no statistically significant difference between the group with intact screw and the group with removed screw. However, the difference between group I and group B was statistically significant (p = 0.01); this was mainly due to the difference in the pain subscore, whereas the subscores for function and alignment were similar. Overall, the patients with broken screw had the best clinical outcome and the most favourable VAS results. The high percentage of radiolucency around the syndesmosis screw in patients who retained an intact or broken screw (66%) is also worth discussion. Theoretically, the narrow zone between the implant and the bone may enable sufficient movement between the fibula and tibia for the physiologically elastic fixation; this is of paramount importance for normal ankle function and good functional outcome after syndesmotic injury. Fig. 3 shows radiographs of a patient with evident radiolucency around the

syndesmosis screw and excellent clinical outcome. Our results are similar to those of Bell and Wong, who reported a study of 33 patients and found no statistically significant difference in functional outcome, ankle pain and range of motion between the group with removed screw and the group in which the screw was retained in place indefinitely [17]. However, they also reported increased rate of screw breakage and osteolysis in the group where the screw was retained. They recommended screw removal before weight-bearing to avoid screw breakage. In our study, screw breakage was not associated with worse clinical outcome. In the retrospective study of 52 patients performed by Hamid et al. [26], favourable outcome in the group with broken screws was reported, but the authors also concluded that the patients in this group tended to be younger compared with the groups with intact and removed screws and performed vigorous rehabilitation, and this could be the reason for both good clinical outcome and screw breakage. Our study is limited by its retrospective design, short follow-up period and low attendance rate. Additionally, the decision for screw removal was based upon individual surgeon preference. There were no statistically significant differences in clinical outcome between the group with the screw retained and the group in which the screw was removed. However, the group with broken screw had the best clinical outcome based on AOFAS score. Widening of the syndesmosis after screw removal was not evident. We do not recommend routine syndesmosis screw removal. References [1] Court-Brown CM, Caesar B. Epidemiology of adult fractures: a review. Injury 2006;37:691–7. [2] Walling AK, Sanders RW. Ankle fractures. In: Coughlin MJ, Mann RA, Saltzman CL, editors. 8th ed., Surgery of the foot and ankle, vol. 2, 8th ed. Philadelphia, PA: Mosby-Elsevier; 2007. p. 1973–2016. [3] Kannus P, Palvanen M, Niemi S, Parkkari J, Ja¨rvinen M. Increasing number and incidence of low-trauma ankle fractures in elderly people: Finnish statistics during 1970–2000 and projections for the future. Bone 2002;31:430–3. [4] Purvis D. Displaced, unstable ankle fractures: classification, incidence, and management of a consecutive series. Clin Orthop Relat Res 1981;165:91–8. [5] Hermans JJ, Beumer A, de Jong AWT, Kleinrensink GJ. Anatomy of the distal tibiofibular syndesmosis in adults: a pictorial essay with a multimodality approach. J Anat 2010;217:633–45. [6] Court-Brown C, McBirnie J, Wilson G. Adult ankle fractures: an increasing problem. Acta Orthop Scand 1998;69:43–7. [7] Cox S, Mukherjree DP, Ogden AL, Mayuex RH, Sadasivan KK, Albright JA, et al. Distal tibiofibular syndesmosis fixation: a cadaveric, simulated fracture stabilization study comparing bioabsorbable and metallic single screw fixation. J Foot Ankle Surg 2005;44:144–511. [8] Thornes B, Shannon F, Guiney AM, Hession P, Masterson E. Suture-button syndesmosis fixation: accelerated rehabilitation and improved outcomes. Clin Orthop Relat Res 2005;431:207–12. [9] Schepers T. Acute distal tibiofibular syndesmosis injury: a systematic review of suture-button versus syndesmotic screw repair. Int Orthop 2012;36(6): 1199–206. [10] Ebraheim NA, Mekhail AO, Gargasz SS. Ankle fractures involving the fibula proximal to the distal tibiofibular syndesmosis. Foot Ankle Int 1997;18(8): 513–21.

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Please cite this article in press as: Kaftandziev I, et al. Fate of the syndesmotic screw—Search for a prudent solution. Injury (2015), http:// dx.doi.org/10.1016/j.injury.2015.10.062