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Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review A.C. Peek *, C.E. Fitzgerald, C. Charalambides Whittington Hospital, London, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 8 May 2014
Although screw fixation remains the most commonly used method of syndesmosis fixation, the ideal screw size, placement, and number remain controversial. In addition, there has been debate as to whether the screw should always be removed, and a number of studies have looked at radiological and functional outcomes. In addition a number of cadaveric models have been developed, but the correlation between cadaveric findings and functional outcomes remains unclear. This systematic review of the literature aims to summarise the available evidence on how many screws should be placed, of what diameter, through how many cortices, at what level, and whether they should be removed. ß 2014 Elsevier Ltd. All rights reserved.
Keywords: Syndesmosis Screw Fixation Evidence
Introduction The distal tibiofibular syndesmosis is a critical structure in maintaining the congruency of the ankle mortise, and the ligamentous structures account for more than 90% of the resistance to lateral fibular displacement [1]. The anterior inferior tibiofibular ligament (AITFL) and the superficial portion of the posterior tibiofibular ligament both hold the fibula to the tibia and the anterior tibiofibular ligaments also resists excessive external rotation of the talus within the mortise. The deep part of the posterior tibiofibular ligament, also called the transverse tibiofibular ligament, extends into the joint and forms part of the articulating surface of the ankle joint. The transverse tibiofibular ligament provides 33% of the resistance to lateral displacement, and the AITFL accounts for 35% [1]. The interosseous membrane is the final component of the syndesmosis, and consists of a number of short strong attachments between the tibia and the fibula, which, though forming a strong attachment, allow enough laxity to permit some physiological movement between the fibula and tibia during normal weight bearing [2,3]. As the foot moves from plantar flexion to dorsiflexion, the mortise widens by 1–2 mm to accommodate the wider anterior part of the talar dome [3]. Syndesmotic injuries are most commonly associated with pronation external rotation injuries, and are thought to occur in 80% of Weber type C injuries [4]. They also occur Weber B injuries
* Corresponding author at: 7 Compton Terrace, UK. Tel.: +44 07870568590. E-mail address: [email protected] (A.C. Peek).
and were found in 17% of supination external rotation type 4 injuries [5]. Isolated syndesmotic injuries, without bony injury, are thought to occur mainly from forced dorsiflexion and external rotation in combination with and axial load. Because the bony injury does not always reliably reveal the underlying ligamentous injury, the need for syndesmotic fixation can be evaluated intraoperatively using a number of stress tests including external rotation of the foot and stressing the fibula with a bone hook. There remain a number of controversies in the management of these injuries, and this paper seeks to clarify the recent evidence base surrounding these. As 97% of UK consultants surveyed in 2008 use syndesmosis screws, rather than a tightrope or other device, we have focussed on technical points surrounding syndesmosis screws specifically [6]. We review the evidence surrounding screw diameter, the number of screws used, the number of cortices fixed, the position of the screw relative to the joint line, and finally whether it should be removed. In their survey, Monga et al. found a wide variation of practice around the UK [6]. For example, 58% of consultants placed their screws through 3 cortices, 33% through 4 cortices. Similar proportions used small and large fragment screws. Thirteen percent did not necessarily remove the syndesmosis screws and 25% allow full or partial weight bearing with the screws in situ. A more recent extensive review of current practice in the Netherlands found similar disparities. Similarly to UK practice, greater than 90% used screw fixation in this injury. Although there was variability in the fixation methods, few surgeons used more than one screw and over 88% routinely removed the syndesmosis screw [7].
http://dx.doi.org/10.1016/j.injury.2014.05.003 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Peek AC, et al. Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review. Injury (2014), http://dx.doi.org/10.1016/j.injury.2014.05.003
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Methods We performed literature searches using Embase, Pubmed/ Medline and the Cochrane library. We included English language papers published between January 1980 and January 2014 when the searches were carried out. We searched using the key terms syndesmo* AND screw* in the title or abstract. This generated 286 unique references and the abstracts were then screened manually to identify the papers of relevance. A total of 58 articles, including review articles and meta-analyses, were reviewed in full by ACP and CEF. Further references of relevance from these papers were then also obtained. Both cadaveric and in vivo studies were included. Where letters and correspondence was sent in to comment on an article, this was also reviewed (Diagram 1). Screw diameter A saw bone model evaluating shear stresses following syndesmotic fixation found a higher shear resistance using a single 4.5 mm screw when compared to a single 3.5 mm screw [8]. In this model the load to failure was the endpoint. However, a cadaveric study comparing syndesmotic widening, axial and torsional loads to failure and stiffness between a single 4.5 mm screw and two 3.5 mm screw could find no statistically significant difference between the two groups [9]. Another cadaveric study
comparing two 3.5 mm or 4.5 mm tri- or quadricortical screws could find no differences in fibula displacement [10]. Because there is physiologically some movement at the tibiofibular syndesmosis, it is not known whether the stiffer construct achieved by a 4.5 mm screw is in fact clinically desirable. In a retrospective analysis of 51 ankles treated by a variety of configurations, neither screw diameter nor the number of screws placed influenced the outcome [11]. However, in this study the majority of cases (68%) had been treated with a single 3.5 mm cortical screw, and the remainder with a variety of screw sizes and numbers. Thus there was no direct clinical comparison between a single 4.5 mm screw and two 3.5 mm screws. In a large retrospective study of 137 patients Stuart et al. [12] found a decreased likelihood of screw breakage as screw diameter increased, from 0% with 4.5 mm screws to 9.5% with 4 mm screws and 12.9% with 3.5 mm screws. A similar effect was found with regards to screw loosening. There was no analysis of screw number in relation to screw size. However neither result was statistically significant on review of the data and there was no association between screw breakage and loss of syndesmotic reduction. Most screw breakages occurred between 3 and 6 months, leading them to conclude screw breakage most probably occurred once the syndesmosis had healed. Loss of reduction was however seen in several patients with screw loosening, although numbers were too small for significant analysis.
Embase and medline search Syndesmo* AND screw* in tle, English language 285 references
All abstracts reviewed Not directly relevant 228 papers
57 Full papers reviewed Including 20 reviews and meta-analyses
Addional papers idenfied from references
Diagram 1. Flow diagram of literature review.
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In a similarly sized retrospective study [13] (106 patients) aimed primarily at determining whether the syndesmosis screw should be removed or not, there was no functional or radiographic differences between patients receiving small or large fragment screws, however the relative risks of screw breakage and loosening with small fragment screw was 2.5 and 3, respectively. It should be noted that only 11/106 patients were treated with large fragment screws. In a large retrospective audit over 7 years, 68 cases were reviewed with the endpoints including failure to anatomically reduce the syndesmosis, or early loss of fixation. A number of variables were analysed for correlation, including size and number of the screws and the number of cortices. 42% of fractures were fixed either using 2 two tricortical 3.5 mm screws or one tricortical 4.5 mm screws. No correlation was found between these variables and re-operation or loss of fixation [14]. Number of screws Few studies directly compare one screw to two, and the discussion with regards to the number of screws to be recommended cannot be taken in isolation from the controversy regarding screw diameter. Xenos et al. published a cadaveric study [15], using radiographic measurements, which compared a single 4.5 mm screw to two. A single screw was found to fail under less force than 2 screws (6.2 vs. 11 Nm). A retrospective radiographic analysis of 86 ankle fixations comparing a single 4.5 mm screw with two 4.5 mm screws found no difference in the radiographic parameters of the syndesmosis at 12 weeks [16]. Clinical outcomes were not reported. In a prospective randomised study [17], with subsequent 8 year follow up data [18], no difference was found between a single 4.5 mm quadricortical screw with planned removal at 2 months and two 3.5 mm tricortical screws which were not routinely removed. Radiological and functional outcomes were studied. The study benefits from a long follow up period and the comparison of two commonly practiced clinical scenarios, even if each variable is not assessed independently. Obesity, a posterior malleolar fragment, and a difference in syndesmotic width of greater than 1.5 mm between the injured and uninjured legs (as measured on CT) were all predictors of a poorer functional outcome. Thus although there is biomechanical evidence that a single screw fails under a lesser load, there is no difference found in radiographic parameters between one screw and two, and in addition, there is no functional difference between two small fragment screws and one large fragment screw. Finaly Gardner et al. [19] compared 2 quadricortical screws with a locked plate and 2 screws in a cadaveric model of Maisoneuve type fractures and found a greater torque to failure in external rotation with the plate. There was no difference in syndesmotic widening found.
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however there was trend towards an increase in loss of syndesmotic reduction in the quadricortical group (p = 0.06). However the groups were uneven, with only 17/137 patients receiving quadricortical screws [12]. A retrospective study of 46 patients compared a single quadricortical or tricortical screw (size not specified) followed by routine removal at 3–7 months in particular in relation to the formation of tibio-fibular synostosis [23]. There was a statistically significant increase in the rate of MRI detected obliteration of the syndesmosis in the quadricortical group however, there was no difference in functional outcome. A prospective randomised study comparing tri- or quadricortical screws in 127 patients two 3.5 mm screws no significant difference was found in screw breakage, screw loosening, loss of reduction or need for the removal of hardware [24]. In the tricortical group there was loss of reduction in three patients, all of whom had been non-compliant with non-weight bearing instructions. No loss of reduction was seen in the quadricortical group. Functional outcomes were not reported. A meta-analysis [25] including those patients mentioned above and the long term follow up published by Wikeroy et al. [18] and Hoiness et al. [17] concluded that early functional outcome scores were higher in the tricortical group however other variables including number of screws and removal were not controlled for specifically. In addition a study of 52 patients evaluating whether to keep or remove the syndesmosis screw used both tri- and quadricortical fixation and no functional difference was found between the groups, or any difference between the rates of screw breakage [26]. Finally there is a case report of tibialis posterior rupture due to a prominent quadricortical screw [27]. Thus overall it can be said that there is no clear evidence to favour either tricortical or quadricortical fixation either from biomechanical studies, and there is no evidence of functional difference between the two groups. As there can be complications associated with quadricortical fixation (synostosis, tendon rupture), it would seem logical to favour tricortical fixation. Position of the screw The screw(s) may be placed either through the syndesmosis (within 2 cm of the tibial plafond) or above the syndesmosis (2– 5 cm from the tibial plafond). A cadaveric study carried out on 17 pairs of legs found a significantly less syndesmotic widening with a trans-syndesmotic screw [28]. A retrospective study comparing supra- and trans-syndesmotic screw placement, with other variables unchanged found no difference in range of movement, clinical or radiological parameters. The authors do acknowledge however that the study was underpowered with 19 patients in each group [29]. Stuart et al.s’ previously mentioned retrospective analysis also found no difference between the two groups [12].
Number of cortices Removal of the screw Three cadaveric studies [10,20,21] have compared tricortical with quadricortical fixation in simulated cadaver fixations, under loads designed to mimic weight bearing. No difference was found. A cadaveric study [22] compared neutral tricortical with quadricortical lag screws (inserted after over drilling the fibula cortices) and found that while they both achieved reduction of the syndesmosis there was greater compression of the syndesmosis using the quadricortical lag screws. Four clinical studies were found, including the previously mentioned retrospective study by Stuart et al. They found no difference in the rate of screw loosening or screw breakage,
In a cadaveric study of 8 ankles, with the syndesmotic ligaments left intact to simulate a healed ligament, range of movement under load was studied before and after a single quadricortical 4.5 mm screw 3 cm above the syndesmosis. No difference was found in plantar or dorsiflexion but there was significantly less talar rotation [30]. There are a number of clinical studies comparing removal or retention of the syndesmosis screw. In a retrospective study in a centre where syndesmotic screws were removed only if dorsiflexion was less than 108 or is they were
Please cite this article in press as: Peek AC, et al. Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review. Injury (2014), http://dx.doi.org/10.1016/j.injury.2014.05.003
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symptomatic, 76 patients were reviewed 1 year postoperatively [13]. Comparing intact with removed screws, functional outcomes were significantly better in those whose screw had been removed. However there was no difference in functional outcomes between those with non-functioning (broken or loose) screws and those whose screw had been removed. In a second study with a similar methodology 52 patients were recruited at a minimum of 1 year postoperatively. Those with broken screws left in situ had the best functional outcome scores and there was no difference found between those with intact or removed screws [26].
A smaller study by Bell et al. reviewed Weber C type fractures in 30 patients and found no differences in functional scores between 23 patients who had their screw removed between 6 and 12 weeks and seven in whom the screw was left in situ [31]. However they concluded screws should be removed in an attempt to prevent screw breakage (which occurred in 2/7 patients), making the argument that a broken screw is more difficult to remove should this become necessary. Miller et al. carried out a prospective study of 25 patients, in which they stabilised the syndesmosis with a locked plate and screw construct through 4 cortices [32]. Despite all patients being
Number of Cortices Cadaveric No difference
RCT with 2x 3.5mm screws No difference
Retrospective Xray review Single 4.5mm vs two 4.5mm No difference Retrospective study No correlation with loss of syndesmotic reduction Sawbone model Greater load to failure with 4.5mm screws
Number of screws Cadaveric Greater load to failure with 2 screws
Size of screws
Cadaveric No difference
Retrospective studies No statistically significant difference
2x 3.5 tricortical left in situ vs 1x 4.5 quadricortical removed Prospective randomized trial 2 small fragment left in situ vs Single large fragment removed No difference
Routine removal or not? Several studies comparing functional outcomes No difference between broken/loose and removed screws Contradictory results comparing intact and removed screws Cadaveric Less talar rotation with screw in situ No difference in dorsiflexion
Position of screw Cadaveric Less widening with trans-syndesmotic screw
Retrospective studies No difference
Diagram 2. Summary of evidence available.
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allowed to weight bear with this construct in situ, only one screw broke and two loosened. All implants were routinely removed at the 4 month mark. Range of movement and functional scores improved significantly following removal of the syndesmotic fixation device. Authors therefore concluded that the above construct should be routinely removed in the postoperative period. In contrast a retrospective review of 52 patients treated with a more minimal construct (single 3.5 mm tricortical screw) found no functional difference when comparing patients who underwent screw removal or whose screw had broken at 6, 12 and 16+ weeks. In addition no difference was found between those with broken or removed screws. More patients showed recurrence of syndesmotic widening in the groups in whom the screws were removed earlier but this was not statistically significant nor was it associated with worse functional scores [33]. Finally a retrospective study following up 63 patients a minimum of 10 months post operatively found no significant difference between those whose screw was retained compared to those whose screw was removed as part of routine practice [34]. In this series the fixation methods varied, according to the surgeons preference. They concluded that routine removal was unnecessary in the absence of symptoms relating to the screw and commented on the financial cost of removal. The integrity of the screws was not commented upon. In addition to the above, there have been a number of case reports and case series relating to complications of syndesmotic screw removal. The largest is a retrospective case series of 76 patients which found 9.2% rate of wound infection, 2.6% of which required reoperation following routine removal between 6 and 8 weeks [35]. There was a 6.6% rate of recurrent diastasis. It should be noted that prophylactic antibiotics were not used at the time of removal in this study. There was a trend towards a lesser risk of recurrent diastasis in patients who were left with the screw in situ for greater than 8 weeks but the sample sizes were too small to detect significance. A large prospective study by Van den Bekerom et al. [36] found just one case of recurrent syndesmosis in 236 consecutive fixations, with routine removal between 6 and 12 weeks. There have been reports of stress fractures of the tibia following syndesmotic screw removal [37,38]. Clanton et al. evaluated the torsional strength of a cadaveric construct in which the syndesmosis screw had been placed then removed, and compared it with the use of a 1/3 tubular plate and screw construct, the plate remaining in situ after removal of the syndesmosis screw [39]. There was no statistical difference found between the two constructs but it was interesting to note that failure occurred through a tibial fracture. Discussion The principle conclusions are summarised in a spider diagram (Diagram 2). Reviewing evidence regarding syndesmosis screws is complex due to the large number of variables involved, each of which may correlate with the others. For example, removal or not of the screw cannot be considered without taking into account the nature of the construct: screw size and number, number of cortices. In addition, there difficulties in interpreting the outcome measures: for example, several studies have defined failure of the screws as breakage or loosening of the screws, whereas one study found this in fact was associated with the best outcomes. Therefore while some studies have concluded that a fixation is superior on the basis of fewer hardware failures it is difficult to extrapolate this to clinical outcomes. This review highlights the caveats that must be considered when translating cadaveric and biomechanical studies into clinical practice.
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There is no functional evidence that a more rigid fixation of the syndesmosis, (with more cortices, a larger or more screws) improves outcome or indeed prevents loss of reduction of the syndesmosis, however a power analysis published in association with Stuart et al.s’ paper suggests very large patient number would be required to demonstrate this [12]. However, it can be noted that there is no functional evidence to favour screw removal other than in the more rigid plate and two quadricortical screw construct described by Miller et al. [32]. In addition there is a documented complication rate following screw removal. 87% of Dutch surgeons removed syndesmosis screws, most between 6 and 8 weeks, and most were single screws [7]. Risk of breakage was sited by a 41% of orthopaedic surgeons for screw removal [7]. Despite the prevalence of this regime, there is no evidence to support it. It is notable that despite the prevalence of the injury, most studies are small, the largest study involved 236 ankles, but most had around 50 patients. Thus lack of evidence of difference may simply represent a type 2 error. There are multiple additional variables that we have not considered in this review, in particular the post-operative regime and weight bearing allowed. This literature review does not examine other types of syndesmotic fixation, for example tightropes or bioabsorbable screws, as these are less frequently used, but we acknowledge that the ongoing controversy as to the optimal mode of syndesmotic screw fixation causes difficulties in the interpretation of trials investigating alternatives. In conclusion we suggest that tricortical fixation with a single 4.5 mm screw left in situ unless it is causing symptoms or reduced range of movement would be the least likely to subject the patient to complications with no evidence to support any other regime has a better functional outcome.
Conflict of interest statement The authors state that there are no conflicts of interest. Acknowledgements We would like to thank Richard Peacock, Lead Clinical Librarian at the (now closed) Archway Healthcare Library for his assistance in searching for and obtaining the referenced papers. Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/j.injury.2014.05. 003. References [1] Ogilvie-Harris DJ, Reed SC, Hedman TP. Disruption of the ankle syndesmosis: biomechanical study of the ligamentous restraints. Arthroscopy 1994;10(October (5)):558–60. [2] Dattani R, Patnaik S, Kantak A, Srikanth B, Selvan TP. Injuries to the tibiofibular syndesmosis. J Bone Joint Surg – Br 2008;90(4):405–10. [3] Norkus SA, Floyd RT. The anatomy and mechanisms of syndesmotic ankle sprains. J Athl Train 2001;36(March (1)):68–73. [4] Van den Bekerom MP, Hogervorst M, Bolhuis M, van HWCNC. Operative aspects of the syndesmotic screw: review of current concepts. Injury 2008;39(4):491–8. [5] Pakarinen HJ, Flinkkila TE, Ohtonen PP, Hyvonen PH, Lakovaara MT, Leppilahti JI, et al. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study. Foot Ankle Int 2011;32(12):1103–9. [6] Monga P, Kumar A, Simons A, Panikker V. Management of distal tibio-fibular syndesmotic injuries: a snapshot of current practice. Acta Orthop Belg 2008;74(3):365–9.
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[7] Schepers T, van WJ, van MP, Vogels LM, van EM. The management of acute distal tibio-fibular syndesmotic injuries: results of a nationwide survey. Injury 2012;43(10):1718–23. [8] Hansen M, Le L, Wertheimer S, Meyer E, Haut R. Syndesmosis fixation: analysis of shear stress via axial load on 3.5-mm and 4.5-mm quadricortical syndesmotic screws. J Foot Ankle Surg 2006;45(2):65–9. [9] Thompson MC, Gesink DS. Biomechenical comparison of syndesmosis fixation with 3.5- and 4.5-millimeter stainless steel screws. Foot Ankle Int 2000;21(9):736–41. [10] Markolf KL, Jackson SR, McAllister DR. Syndesmosis fixation using dual 3.5 mm and 4.5 mm screws with tricortical and quadricortical purchase: a biomechanical study. Foot Ankle Int 2013;34(May (5)):734–9. [11] Weening B, Bhandari M. Predictors of functional outcome following transsyndesmotic screw fixation of ankle fractures. J Orthop Trauma 2005;19(2): 102–8. [12] Stuart K, Panchbhavi VK. The fate of syndesmotic screws. Foot Ankle Int 2011;32(5):S519–25. [13] Manjoo A, Sanders DW, Tieszer C, MacLeod MD. Functional and radiographic results of patients with syndesmotic screw fixation: implications for screw removal. J Orthop Trauma 2010;24(1):2–6. [14] Symeonidis PD, Iselin LD, Chehade M, Stavrou P. Common pitfalls in syndesmotic rupture management: a clinical audit. Foot Ankle Int 2013;34(3):345– 50. [15] Xenos JS, Hopkinson WJ, Mulligan ME, Olson EJ, Popovic NA. The tibiofibular syndesmosis. Evaluation of the ligamentous structures, methods of fixation, and radiographic assessment. J Bone Joint Surg – Am 1995;77(6):847–56. [16] Jordan TH, Talarico RH, Schuberth JM. The radiographic fate of the syndesmosis after trans-syndesmotic screw removal in displaced ankle fractures. J Foot Ankle Surg 2011;50(4):407–12. [17] Hoiness P, Stromsoe K. Tricortical versus quadricortical syndesmosis fixation in ankle fractures: a prospective, randomized study comparing two methods of syndesmosis fixation. J Orthop Trauma 2004;18(6):331–7. [18] Wikeroy AK, Hoiness PR, Andreassen GS, Hellund JC, Madsen JE. No difference in functional and radiographic results 8.4 years after quadricortical compared with tricortical syndesmosis fixation in ankle fractures. J Orthop Trauma 2010;24(1):17–23. [19] Gardner R, Yousri T, Holmes F, Clark D, Pollintine P, Miles AW, et al. Stabilization of the syndesmosis in the Maisonneuve fracture – a biomechanical study comparing 2-hole locking plate and quadricortical screw fixation. J Orthop Trauma 2013;27(4):212–6. [20] Nousiainen MT, McConnell AJ, Zdero R, McKee MD, Bhandari M, Schemitsch EH. The influence of the number of cortices of screw purchase and ankle position in Weber C ankle fracture fixation. J Orthop Trauma 2008;22(7):473– 8. [21] Beumer A, Campo MM, Niesing R, Day J, Kleinrensink GJ, Swierstra BA. Screw fixation of the syndesmosis: a cadaver model comparing stainless steel and titanium screws and three and four cortical fixation. Injury 2005;36(1):60–4. [22] Darwish HH, Glisson RR, DeOrio JK. Compression screw fixation of the syndesmosis. Foot Ankle Int 2012;33(10):893–9.
[23] Karapinar H, Kalenderer O, Karapinar L, Altay T, Manisali M, Gunal I. Effects of three- or four-cortex syndesmotic fixation in ankle fractures. J Am Podiatr Med Assoc 2007;97(6):457–9. [24] Moore JA, Shank JR, Morgan SJ, Smith WR. Syndesmosis fixation: a comparison of three and four cortices of screw fixation without hardware removal. Foot Ankle Int 2006;27(8):567–72. [25] Wang C, Ma X, Wang X, Huang J, Zhang C, Chen L. Internal fixation of distal tibiofibular syndesmotic injuries: a systematic review with meta-analysis. Int Orthop 2013;37(July (9)):1755–63. [26] Hamid N, Loeffler BJ, Braddy W, Kellam JF, Cohen BE, Bosse MJ. Outcome after fixation of ankle fractures with an injury to the syndesmosis: the effect of the syndesmosis screw. J Bone Joint Surg – Br 2009;91(8):1069–73. [27] Kwon JY, Campbell JT, Myerson MS. Posterior tibial tendon tear after 4-cortex syndesmotic screw fixation: a case report and literature review. J Orthop Trauma 2012;26(6):e66–9. [28] McBryde A, Chiasson B, Wilhelm A, Donovan F, Ray T, Bacilla P. Syndesmotic screw placement: a biomechanical analysis. Foot Ankle Int 1997;18(5):262–6. [29] Kukreti S, Faraj A, Miles JN. Does position of syndesmotic screw affect functional and radiological outcome in ankle fractures? Injury 2005;36(9): 1121–4. [30] Needleman RL, Skrade DA, Stiehl JB. Effect of the syndesmotic screw on ankle motion. Foot Ankle 1989;10(1):17–24. [31] Bell DP, Wong MK. Syndesmotic screw fixation in Weber C ankle injuriesshould the screw be removed before weight bearing? Injury 2006;37(9):891– 8. [32] Miller AN, Paul O, Boraiah S, Parker RJ, Helfet DL, Lorich DG. Functional outcomes after syndesmotic screw fixation and removal. J Orthop Trauma 2010;24(1):12–6. [33] Hsu YT, Wu CC, Lee WC, Fan KF, Tseng IC, Lee PC. Surgical treatment of syndesmotic diastasis: emphasis on effect of syndesmotic screw on ankle function. Int Orthop 2011;35(3):359–64. [34] Tucker A, Street J, Kealey D, McDonald S, Stevenson M. Functional outcomes following syndesmotic fixation: a comparison of screws retained in situ versus routine removal – is it really necessary? Injury 2013;44(December (12)): 1880–4. [35] Schepers T, Van EM, de EMR, Van MME. Complications of syndesmotic screw removal. Foot Ankle Int 2011;32(11):1040–4. [36] Van den Bekerom MPJ, Kloen P, Luitse JSK, Raaymakers ELFB. Complications of distal tibiofibular syndesmotic screw stabilization: analysis of 236 patients. J Foot Ankle Surg 2013;52(July (4)):456–9. [37] Citak M, Backhaus M, Muhr G, Kalicke T. Distal tibial fracture post syndesmotic screw removal: an adverse complication. Arch Orthop Trauma Surg 2011;131(10): 1405–8. [38] Clarke M, Covey DC. Stress fracture of the distal tibia following syndesmosis screw removal. Curr Orthop Pract 2010;21(2):E8–12. [39] Clanton TO, Matheny LM, Jarvis HC, Lewis EV, Ambrose CG. Quantitative analysis of torsional stiffness in supplemental one-third tubular plate fixation in the management of isolated syndesmosis injuries: a biomechanical study. Foot Ankle Int 2013;34(2):267–72.
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Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review A.C. Peek *, C.E. Fitzgerald, C. Charalambides Whittington Hospital, London, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 8 May 2014
Although screw fixation remains the most commonly used method of syndesmosis fixation, the ideal screw size, placement, and number remain controversial. In addition, there has been debate as to whether the screw should always be removed, and a number of studies have looked at radiological and functional outcomes. In addition a number of cadaveric models have been developed, but the correlation between cadaveric findings and functional outcomes remains unclear. This systematic review of the literature aims to summarise the available evidence on how many screws should be placed, of what diameter, through how many cortices, at what level, and whether they should be removed. ß 2014 Elsevier Ltd. All rights reserved.
Keywords: Syndesmosis Screw Fixation Evidence
Introduction The distal tibiofibular syndesmosis is a critical structure in maintaining the congruency of the ankle mortise, and the ligamentous structures account for more than 90% of the resistance to lateral fibular displacement [1]. The anterior inferior tibiofibular ligament (AITFL) and the superficial portion of the posterior tibiofibular ligament both hold the fibula to the tibia and the anterior tibiofibular ligaments also resists excessive external rotation of the talus within the mortise. The deep part of the posterior tibiofibular ligament, also called the transverse tibiofibular ligament, extends into the joint and forms part of the articulating surface of the ankle joint. The transverse tibiofibular ligament provides 33% of the resistance to lateral displacement, and the AITFL accounts for 35% [1]. The interosseous membrane is the final component of the syndesmosis, and consists of a number of short strong attachments between the tibia and the fibula, which, though forming a strong attachment, allow enough laxity to permit some physiological movement between the fibula and tibia during normal weight bearing [2,3]. As the foot moves from plantar flexion to dorsiflexion, the mortise widens by 1–2 mm to accommodate the wider anterior part of the talar dome [3]. Syndesmotic injuries are most commonly associated with pronation external rotation injuries, and are thought to occur in 80% of Weber type C injuries [4]. They also occur Weber B injuries
* Corresponding author at: 7 Compton Terrace, UK. Tel.: +44 07870568590. E-mail address: [email protected] (A.C. Peek).
and were found in 17% of supination external rotation type 4 injuries [5]. Isolated syndesmotic injuries, without bony injury, are thought to occur mainly from forced dorsiflexion and external rotation in combination with and axial load. Because the bony injury does not always reliably reveal the underlying ligamentous injury, the need for syndesmotic fixation can be evaluated intraoperatively using a number of stress tests including external rotation of the foot and stressing the fibula with a bone hook. There remain a number of controversies in the management of these injuries, and this paper seeks to clarify the recent evidence base surrounding these. As 97% of UK consultants surveyed in 2008 use syndesmosis screws, rather than a tightrope or other device, we have focussed on technical points surrounding syndesmosis screws specifically [6]. We review the evidence surrounding screw diameter, the number of screws used, the number of cortices fixed, the position of the screw relative to the joint line, and finally whether it should be removed. In their survey, Monga et al. found a wide variation of practice around the UK [6]. For example, 58% of consultants placed their screws through 3 cortices, 33% through 4 cortices. Similar proportions used small and large fragment screws. Thirteen percent did not necessarily remove the syndesmosis screws and 25% allow full or partial weight bearing with the screws in situ. A more recent extensive review of current practice in the Netherlands found similar disparities. Similarly to UK practice, greater than 90% used screw fixation in this injury. Although there was variability in the fixation methods, few surgeons used more than one screw and over 88% routinely removed the syndesmosis screw [7].
http://dx.doi.org/10.1016/j.injury.2014.05.003 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.
Please cite this article in press as: Peek AC, et al. Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review. Injury (2014), http://dx.doi.org/10.1016/j.injury.2014.05.003
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Methods We performed literature searches using Embase, Pubmed/ Medline and the Cochrane library. We included English language papers published between January 1980 and January 2014 when the searches were carried out. We searched using the key terms syndesmo* AND screw* in the title or abstract. This generated 286 unique references and the abstracts were then screened manually to identify the papers of relevance. A total of 58 articles, including review articles and meta-analyses, were reviewed in full by ACP and CEF. Further references of relevance from these papers were then also obtained. Both cadaveric and in vivo studies were included. Where letters and correspondence was sent in to comment on an article, this was also reviewed (Diagram 1). Screw diameter A saw bone model evaluating shear stresses following syndesmotic fixation found a higher shear resistance using a single 4.5 mm screw when compared to a single 3.5 mm screw [8]. In this model the load to failure was the endpoint. However, a cadaveric study comparing syndesmotic widening, axial and torsional loads to failure and stiffness between a single 4.5 mm screw and two 3.5 mm screw could find no statistically significant difference between the two groups [9]. Another cadaveric study
comparing two 3.5 mm or 4.5 mm tri- or quadricortical screws could find no differences in fibula displacement [10]. Because there is physiologically some movement at the tibiofibular syndesmosis, it is not known whether the stiffer construct achieved by a 4.5 mm screw is in fact clinically desirable. In a retrospective analysis of 51 ankles treated by a variety of configurations, neither screw diameter nor the number of screws placed influenced the outcome [11]. However, in this study the majority of cases (68%) had been treated with a single 3.5 mm cortical screw, and the remainder with a variety of screw sizes and numbers. Thus there was no direct clinical comparison between a single 4.5 mm screw and two 3.5 mm screws. In a large retrospective study of 137 patients Stuart et al. [12] found a decreased likelihood of screw breakage as screw diameter increased, from 0% with 4.5 mm screws to 9.5% with 4 mm screws and 12.9% with 3.5 mm screws. A similar effect was found with regards to screw loosening. There was no analysis of screw number in relation to screw size. However neither result was statistically significant on review of the data and there was no association between screw breakage and loss of syndesmotic reduction. Most screw breakages occurred between 3 and 6 months, leading them to conclude screw breakage most probably occurred once the syndesmosis had healed. Loss of reduction was however seen in several patients with screw loosening, although numbers were too small for significant analysis.
Embase and medline search Syndesmo* AND screw* in tle, English language 285 references
All abstracts reviewed Not directly relevant 228 papers
57 Full papers reviewed Including 20 reviews and meta-analyses
Addional papers idenfied from references
Diagram 1. Flow diagram of literature review.
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In a similarly sized retrospective study [13] (106 patients) aimed primarily at determining whether the syndesmosis screw should be removed or not, there was no functional or radiographic differences between patients receiving small or large fragment screws, however the relative risks of screw breakage and loosening with small fragment screw was 2.5 and 3, respectively. It should be noted that only 11/106 patients were treated with large fragment screws. In a large retrospective audit over 7 years, 68 cases were reviewed with the endpoints including failure to anatomically reduce the syndesmosis, or early loss of fixation. A number of variables were analysed for correlation, including size and number of the screws and the number of cortices. 42% of fractures were fixed either using 2 two tricortical 3.5 mm screws or one tricortical 4.5 mm screws. No correlation was found between these variables and re-operation or loss of fixation [14]. Number of screws Few studies directly compare one screw to two, and the discussion with regards to the number of screws to be recommended cannot be taken in isolation from the controversy regarding screw diameter. Xenos et al. published a cadaveric study [15], using radiographic measurements, which compared a single 4.5 mm screw to two. A single screw was found to fail under less force than 2 screws (6.2 vs. 11 Nm). A retrospective radiographic analysis of 86 ankle fixations comparing a single 4.5 mm screw with two 4.5 mm screws found no difference in the radiographic parameters of the syndesmosis at 12 weeks [16]. Clinical outcomes were not reported. In a prospective randomised study [17], with subsequent 8 year follow up data [18], no difference was found between a single 4.5 mm quadricortical screw with planned removal at 2 months and two 3.5 mm tricortical screws which were not routinely removed. Radiological and functional outcomes were studied. The study benefits from a long follow up period and the comparison of two commonly practiced clinical scenarios, even if each variable is not assessed independently. Obesity, a posterior malleolar fragment, and a difference in syndesmotic width of greater than 1.5 mm between the injured and uninjured legs (as measured on CT) were all predictors of a poorer functional outcome. Thus although there is biomechanical evidence that a single screw fails under a lesser load, there is no difference found in radiographic parameters between one screw and two, and in addition, there is no functional difference between two small fragment screws and one large fragment screw. Finaly Gardner et al. [19] compared 2 quadricortical screws with a locked plate and 2 screws in a cadaveric model of Maisoneuve type fractures and found a greater torque to failure in external rotation with the plate. There was no difference in syndesmotic widening found.
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however there was trend towards an increase in loss of syndesmotic reduction in the quadricortical group (p = 0.06). However the groups were uneven, with only 17/137 patients receiving quadricortical screws [12]. A retrospective study of 46 patients compared a single quadricortical or tricortical screw (size not specified) followed by routine removal at 3–7 months in particular in relation to the formation of tibio-fibular synostosis [23]. There was a statistically significant increase in the rate of MRI detected obliteration of the syndesmosis in the quadricortical group however, there was no difference in functional outcome. A prospective randomised study comparing tri- or quadricortical screws in 127 patients two 3.5 mm screws no significant difference was found in screw breakage, screw loosening, loss of reduction or need for the removal of hardware [24]. In the tricortical group there was loss of reduction in three patients, all of whom had been non-compliant with non-weight bearing instructions. No loss of reduction was seen in the quadricortical group. Functional outcomes were not reported. A meta-analysis [25] including those patients mentioned above and the long term follow up published by Wikeroy et al. [18] and Hoiness et al. [17] concluded that early functional outcome scores were higher in the tricortical group however other variables including number of screws and removal were not controlled for specifically. In addition a study of 52 patients evaluating whether to keep or remove the syndesmosis screw used both tri- and quadricortical fixation and no functional difference was found between the groups, or any difference between the rates of screw breakage [26]. Finally there is a case report of tibialis posterior rupture due to a prominent quadricortical screw [27]. Thus overall it can be said that there is no clear evidence to favour either tricortical or quadricortical fixation either from biomechanical studies, and there is no evidence of functional difference between the two groups. As there can be complications associated with quadricortical fixation (synostosis, tendon rupture), it would seem logical to favour tricortical fixation. Position of the screw The screw(s) may be placed either through the syndesmosis (within 2 cm of the tibial plafond) or above the syndesmosis (2– 5 cm from the tibial plafond). A cadaveric study carried out on 17 pairs of legs found a significantly less syndesmotic widening with a trans-syndesmotic screw [28]. A retrospective study comparing supra- and trans-syndesmotic screw placement, with other variables unchanged found no difference in range of movement, clinical or radiological parameters. The authors do acknowledge however that the study was underpowered with 19 patients in each group [29]. Stuart et al.s’ previously mentioned retrospective analysis also found no difference between the two groups [12].
Number of cortices Removal of the screw Three cadaveric studies [10,20,21] have compared tricortical with quadricortical fixation in simulated cadaver fixations, under loads designed to mimic weight bearing. No difference was found. A cadaveric study [22] compared neutral tricortical with quadricortical lag screws (inserted after over drilling the fibula cortices) and found that while they both achieved reduction of the syndesmosis there was greater compression of the syndesmosis using the quadricortical lag screws. Four clinical studies were found, including the previously mentioned retrospective study by Stuart et al. They found no difference in the rate of screw loosening or screw breakage,
In a cadaveric study of 8 ankles, with the syndesmotic ligaments left intact to simulate a healed ligament, range of movement under load was studied before and after a single quadricortical 4.5 mm screw 3 cm above the syndesmosis. No difference was found in plantar or dorsiflexion but there was significantly less talar rotation [30]. There are a number of clinical studies comparing removal or retention of the syndesmosis screw. In a retrospective study in a centre where syndesmotic screws were removed only if dorsiflexion was less than 108 or is they were
Please cite this article in press as: Peek AC, et al. Syndesmosis screws: How many, what diameter, where and should they be removed? A literature review. Injury (2014), http://dx.doi.org/10.1016/j.injury.2014.05.003
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symptomatic, 76 patients were reviewed 1 year postoperatively [13]. Comparing intact with removed screws, functional outcomes were significantly better in those whose screw had been removed. However there was no difference in functional outcomes between those with non-functioning (broken or loose) screws and those whose screw had been removed. In a second study with a similar methodology 52 patients were recruited at a minimum of 1 year postoperatively. Those with broken screws left in situ had the best functional outcome scores and there was no difference found between those with intact or removed screws [26].
A smaller study by Bell et al. reviewed Weber C type fractures in 30 patients and found no differences in functional scores between 23 patients who had their screw removed between 6 and 12 weeks and seven in whom the screw was left in situ [31]. However they concluded screws should be removed in an attempt to prevent screw breakage (which occurred in 2/7 patients), making the argument that a broken screw is more difficult to remove should this become necessary. Miller et al. carried out a prospective study of 25 patients, in which they stabilised the syndesmosis with a locked plate and screw construct through 4 cortices [32]. Despite all patients being
Number of Cortices Cadaveric No difference
RCT with 2x 3.5mm screws No difference
Retrospective Xray review Single 4.5mm vs two 4.5mm No difference Retrospective study No correlation with loss of syndesmotic reduction Sawbone model Greater load to failure with 4.5mm screws
Number of screws Cadaveric Greater load to failure with 2 screws
Size of screws
Cadaveric No difference
Retrospective studies No statistically significant difference
2x 3.5 tricortical left in situ vs 1x 4.5 quadricortical removed Prospective randomized trial 2 small fragment left in situ vs Single large fragment removed No difference
Routine removal or not? Several studies comparing functional outcomes No difference between broken/loose and removed screws Contradictory results comparing intact and removed screws Cadaveric Less talar rotation with screw in situ No difference in dorsiflexion
Position of screw Cadaveric Less widening with trans-syndesmotic screw
Retrospective studies No difference
Diagram 2. Summary of evidence available.
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allowed to weight bear with this construct in situ, only one screw broke and two loosened. All implants were routinely removed at the 4 month mark. Range of movement and functional scores improved significantly following removal of the syndesmotic fixation device. Authors therefore concluded that the above construct should be routinely removed in the postoperative period. In contrast a retrospective review of 52 patients treated with a more minimal construct (single 3.5 mm tricortical screw) found no functional difference when comparing patients who underwent screw removal or whose screw had broken at 6, 12 and 16+ weeks. In addition no difference was found between those with broken or removed screws. More patients showed recurrence of syndesmotic widening in the groups in whom the screws were removed earlier but this was not statistically significant nor was it associated with worse functional scores [33]. Finally a retrospective study following up 63 patients a minimum of 10 months post operatively found no significant difference between those whose screw was retained compared to those whose screw was removed as part of routine practice [34]. In this series the fixation methods varied, according to the surgeons preference. They concluded that routine removal was unnecessary in the absence of symptoms relating to the screw and commented on the financial cost of removal. The integrity of the screws was not commented upon. In addition to the above, there have been a number of case reports and case series relating to complications of syndesmotic screw removal. The largest is a retrospective case series of 76 patients which found 9.2% rate of wound infection, 2.6% of which required reoperation following routine removal between 6 and 8 weeks [35]. There was a 6.6% rate of recurrent diastasis. It should be noted that prophylactic antibiotics were not used at the time of removal in this study. There was a trend towards a lesser risk of recurrent diastasis in patients who were left with the screw in situ for greater than 8 weeks but the sample sizes were too small to detect significance. A large prospective study by Van den Bekerom et al. [36] found just one case of recurrent syndesmosis in 236 consecutive fixations, with routine removal between 6 and 12 weeks. There have been reports of stress fractures of the tibia following syndesmotic screw removal [37,38]. Clanton et al. evaluated the torsional strength of a cadaveric construct in which the syndesmosis screw had been placed then removed, and compared it with the use of a 1/3 tubular plate and screw construct, the plate remaining in situ after removal of the syndesmosis screw [39]. There was no statistical difference found between the two constructs but it was interesting to note that failure occurred through a tibial fracture. Discussion The principle conclusions are summarised in a spider diagram (Diagram 2). Reviewing evidence regarding syndesmosis screws is complex due to the large number of variables involved, each of which may correlate with the others. For example, removal or not of the screw cannot be considered without taking into account the nature of the construct: screw size and number, number of cortices. In addition, there difficulties in interpreting the outcome measures: for example, several studies have defined failure of the screws as breakage or loosening of the screws, whereas one study found this in fact was associated with the best outcomes. Therefore while some studies have concluded that a fixation is superior on the basis of fewer hardware failures it is difficult to extrapolate this to clinical outcomes. This review highlights the caveats that must be considered when translating cadaveric and biomechanical studies into clinical practice.
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There is no functional evidence that a more rigid fixation of the syndesmosis, (with more cortices, a larger or more screws) improves outcome or indeed prevents loss of reduction of the syndesmosis, however a power analysis published in association with Stuart et al.s’ paper suggests very large patient number would be required to demonstrate this [12]. However, it can be noted that there is no functional evidence to favour screw removal other than in the more rigid plate and two quadricortical screw construct described by Miller et al. [32]. In addition there is a documented complication rate following screw removal. 87% of Dutch surgeons removed syndesmosis screws, most between 6 and 8 weeks, and most were single screws [7]. Risk of breakage was sited by a 41% of orthopaedic surgeons for screw removal [7]. Despite the prevalence of this regime, there is no evidence to support it. It is notable that despite the prevalence of the injury, most studies are small, the largest study involved 236 ankles, but most had around 50 patients. Thus lack of evidence of difference may simply represent a type 2 error. There are multiple additional variables that we have not considered in this review, in particular the post-operative regime and weight bearing allowed. This literature review does not examine other types of syndesmotic fixation, for example tightropes or bioabsorbable screws, as these are less frequently used, but we acknowledge that the ongoing controversy as to the optimal mode of syndesmotic screw fixation causes difficulties in the interpretation of trials investigating alternatives. In conclusion we suggest that tricortical fixation with a single 4.5 mm screw left in situ unless it is causing symptoms or reduced range of movement would be the least likely to subject the patient to complications with no evidence to support any other regime has a better functional outcome.
Conflict of interest statement The authors state that there are no conflicts of interest. Acknowledgements We would like to thank Richard Peacock, Lead Clinical Librarian at the (now closed) Archway Healthcare Library for his assistance in searching for and obtaining the referenced papers. Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/j.injury.2014.05. 003. References [1] Ogilvie-Harris DJ, Reed SC, Hedman TP. Disruption of the ankle syndesmosis: biomechanical study of the ligamentous restraints. Arthroscopy 1994;10(October (5)):558–60. [2] Dattani R, Patnaik S, Kantak A, Srikanth B, Selvan TP. Injuries to the tibiofibular syndesmosis. J Bone Joint Surg – Br 2008;90(4):405–10. [3] Norkus SA, Floyd RT. The anatomy and mechanisms of syndesmotic ankle sprains. J Athl Train 2001;36(March (1)):68–73. [4] Van den Bekerom MP, Hogervorst M, Bolhuis M, van HWCNC. Operative aspects of the syndesmotic screw: review of current concepts. Injury 2008;39(4):491–8. [5] Pakarinen HJ, Flinkkila TE, Ohtonen PP, Hyvonen PH, Lakovaara MT, Leppilahti JI, et al. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study. Foot Ankle Int 2011;32(12):1103–9. [6] Monga P, Kumar A, Simons A, Panikker V. Management of distal tibio-fibular syndesmotic injuries: a snapshot of current practice. Acta Orthop Belg 2008;74(3):365–9.
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