Prevalence and risk factors for re-interventions following reamed intramedullary tibia nailing

Injury, Int. J. Care Injured 47S7 (2016) S49–S52

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Prevalence and risk factors for re-interventions following reamed intramedullary tibia nailing Petros Z. Stavroua, Vincenzo Cirielloa, Stylianos Theocharakisa, Suribabu Gudipatia, Theodoros H. Tosounidisa,b, Nikolaos K. Kanakarisa, Peter V. Giannoudisa,b, * a

Academic department of Trauma and Orthopaedics, Leeds Teaching Hospitals, School of Medicine, University of Leeds, Leeds, UK NIHR Leeds Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK

b

K E Y W O R D S

A B S T R A C T

tibial nailing

Introduction: This study aimed to identify the prevalence and the risk factors for re-interventions following reamed intramedullary nailing (IMN) of tibial shaft fractures. Patients and methods: We retrospectively analysed a prospectively populated data of adult patients that underwent reamed intramedullary nailing for stabilization of tibial shaft fractures over a period of three years. Exclusion criteria were immature patients, pathological and periarticular fractures. Data collected included patient demographics, mechanism of injury, open or closed injury pattern, ISS, perioperative complications, reintervention characteristics (time, cause, number), smoking habits, medical co-morbidities and progress to radiological fracture union. Fractures were classified according to AO/OTA system. The cohort of these patients was divided in two groups: Group 1 included the patients who healed uneventfully and Group 2 included the patients who underwent a re-intervention for the healing of the fracture. A logistic regression analysis model was used to assess the odds ratio (OR) of identified risk factors predicting the necessity of re-interventions. Results: 181 (129 male) patients with a mean age of 37 (range 16–87) met the inclusion criteria. 30 patients were excluded due to inadequate follow up, leaving 151 patients for the study group. 119 patients were included in Group 1. 32 (21.2%) patients who had at least one re-intervention (range 1–3) were included in Group 2. The most common causes for re-intervention were aseptic non-union (31.3%) and removal of implants due to soft tissue irritation/anterior knee pain (31.3%), followed by early metalwork failure (12.5%), infected non-union (9.4%), correction of rotational deformities (9.4%) and canal intramedullary sepsis with evident fracture healing (6.3%). 29 (25.8%) from the study cohort patients sustained an open fracture and 8 of them underwent a re-intervention (20.5% of interventions). Incidence of fracture pattern 42-B, C was statistically significant greater in the reintervention (40.6%) compared to the non-re-intervention group (23.53%) ( p = 0.026). Risk factors predicting the need for re-interventions included the type of fracture B, C ( p = 0.026 OR: 2.528, range: 1.117–5.721) and increased alcohol consumption ( p = 0.027/OR: 2.618, range: 1.116–6.141). Conclusion: Fracture pattern and alcohol abuse were highly predictive for re-interventions following reamed IM nailing for stabilization of acute tibial shaft fractures. © 2016 Elsevier Ltd. All rights reserved.

re-operations risk factors

Introduction Intramedullary nailing (IMN) is the gold standard of the treatment of tibial shaft fractures. The re-operation and major complications rates of reamed and unreamed IMN are the same whilst the implant

* Corresponding author at: Peter V. Giannoudis, Academic Department of Trauma and Orthopaedics, School of Medicine, University of Leeds, Leeds General Infirmary, Clarendon Wing, Level D, LS13EX, Leeds, West Yorkshire, United Kingdom. Tel.: +44-113-3922750; Fax: +44-113-3923290. E-mail address: [email protected] (P.V. Giannoudis).

0020-1383 / © 2016 Elsevier Ltd. All rights reserved.

failure is observed in lower incidence in reamed nailing procedures [1]. The overall reoperation rate after reamed IMN has been reported to range between 12% and 44% [2]. The major reasons for re-operations include but are not limited to non-union, mal-union, infection and anterior knee pain [3–7]. High energy mechanism, fracture gap, full weight bearing and stainless steel implants have been considered significant factors predisposing to negative events after tibia nailing [8]. The aim of this study is to determine the prevalence and identify the risk factors of re-interventions after reamed IMN of the tibia in a Level-1 trauma centre in the UK.

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Patients and methods

Results

We have conducted a retrospective analysis of prospectively collected data of all the adult patients that were admitted to our institution (Level-1 Trauma Centre in the UK) over a three-year period (January 2008 to January 2011) and underwent reamed intramedullary nailing for stabilization of tibial shaft fractures. Immature patient and patients with pathological and/or periarticular fractures were excluded from the study. The patients were divided into two groups. Group 1 consisted of patients who underwent only one surgical intervention (uncomplicated group) and Group 2 consisted of patients who had at least 1 reoperation after the index intramedullary nail fixation (re-intervention group). The following standardised surgical protocol for the index IMN procedure was applied: Administration of one dose of intravenous antibiotics 30 minutes prior to anaesthesia. No tourniquet was used and the IMN was performed on a radiolucent table (OSI). The Stryker T2 nail (Standard T2, Stryker Osteosynthesis, Schoenkirchen, Germany) was used in all cases. Proximal and distal interlocking screws were applied following standard reaming in all cases. The postoperative rehabilitation protocol was consisted of toe-touch weight bearing for 6 weeks followed by gradual progression to full weight-bearing within the next 4–6 weeks. Clinical and radiological follow up at the outpatient clinics was performed at 2, 4, 8, 12, 16, weeks and at 6, 9, 12 months (or longer if indicated). Chemical thromboprophylaxis (4500 IU sq Tinzaparin, once daily) was given for 6 weeks. Open fractures were initially managed with radical surgical debridement and where appropriate a temporary external fixator was applied prior to the definitive nailing procedure. Soft tissue coverage was provided according to the local soft tissue requirements by the plastic surgical team. Definitive soft tissue cover was carried out within 5 days from the initial injury. In open fractures antibiotics were administered for 3 days or until definitive soft tissue coverage was carried out. Clinical data were collected form the patients’ case notes and clinical letters from outpatients clinics. Imaging studies (plain radiographs) were reviewed using the Picture Archiving and Communication System (PACS). Data collected included basic demographics (gender and age), mechanism of injury (road traffic collision, fall, assault, sports injury, other), fracture classification (AO/OTA system) in simple 42-A, wedge 42-B and complex 42-C patterns), open or closed injuries [9], Injury Severity Score (ISS) [10]. Perioperative complications (deep vein thrombosis, compartment syndrome, neurovascular or iatrogenic damage), length of hospital stay, causes/number of re-interventions and factors known to predispose to suboptimal outcome after tibial nailing such as smoking habits, drug and alcohol abuse, diabetes, obesity were also collected. Time to clinical and radiological union was also recorded. The clinical and radiological information were collected in a computerized database using the Filemaker Pro 12 (FileMaker, Inc, FileMaker International). Institutional board review was obtained for this study. Continuous variables were summarized in terms of mean values with standard deviation and range as measures of variability. Normality was evaluated by Kolmogorov – Smirnov Z test. Categorical values were presented as absolute frequencies and percentages. Continuous variables were compared using the Mann-Whitney U test for non-parametric unpaired comparison, whilst categorical data were compared using Chi-Square test and when the expected counts were less than 5, the Fisher’s exact test was used. We considered a p value of less than 0.05 as statistically significant. A logistic regression analysis was performed on the variables found significantly different between the two groups (re-intervention vs. non re-intervention). Statistical analysis was performed using the SPSS v.13.0 software (SPSS Inc.; Chicago, IL).

Out of 181 patients deemed eligible to be included in this study, 30 patients were excluded due to inadequate follow up or incomplete data. In total, 151 (104 male and 47 female) patients formed the subject of this analysis. 119 and 32 patients were included in Group-1 (uncomplicated union group) and Group-2 respectively (reintervention group). More than half of the patients (50.99%) were under the age of 35, and the mean age for the entire cohort was 37.06 years (range 16–87). The mean age for the male population was 34.12 (range 16–81 years), whereas that of the female population was 43.57 (range 17–87 years). The most common mechanism of injury for the entire cohort was a fall from height (70 patients, 46.36%), followed by road traffic collision (41 patients, 27.15%), sports injuries (22 patients, 14.57%), assault (8 patients, 5.30%) and other or unspecified causes (10 patients, 6.62%). 110 patients suffered a simple (42-A) (72.85%), 36 patients a wedge (42-B) (23.84%) and 5 patients a complex (42-C) (3.31%) fracture. Overall, 39 (25.83%) patients sustained an open fracture and 8 of them (20.51%) underwent a re-intervention. In Group 1, radiological union was evident in 5.8 months (range 11.9–25.0 weeks). In Group 2, twenty-one (65.63%), nine (28.13%) and two (6.25%) patients underwent 1, 2 and 3 reoperations respectively. The re-interventions were more frequent in the male population than the female 23/32 (71.88%) patients ( p = 0.003). The incidence of 42-B, 42-C fracture pattern was the highest, ( p = 0.05) in group 2. Causes identified for the first re-intervention (Figure 1) were: aseptic nonunion (10 patients, 31.25%), soft tissue irritation/anterior knee pain (10 patients, 31.25%), loss of reduction and metalwork failure (4 patients, 12.50%), rotational deformity (3 patients, 9.38%), infected non-union (3 patients, 9.38%), canal intramedullary sepsis with evident fracture healing (2 patients, 6.25%), Figure 2 reveals the causes for the second

Fig. 1. Causes for first re-intervention.

Fig. 2. Causes for second re-intervention.

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Table 1. Assessed risk factors in each of the groups with prevalence for each Patients Group 1 (119)

Prevalence in Group 1 (%)

Patients Group 2 (32)

Prevalence in Group 2 (%)

Males Age >34 Open fracture Neurovascular preop Damage Preop Dvt Preop compartment syndrome

81 55 31 2 0 2

68.07 46.22 26.05 1.68 0 1.68

23 18 8 1 0 1

71.88 59.38 25.00 3.13 0 3.13

42-b or 42-c fracture type ISS >15 NISS >15 Obesity Diabetes Smoking Drug abuse

28 3 9 12 2 45 6

23.53 2.52 7.56 10.08 1.68 37.82 5.04

13 1 3 6 2 12 1

40.62 3.13 9.38 18.75 6.25 37.50 3.13

Alcohol abuse Postop Dvt Postop compartment Syndrome Iatrogenic damage

22 0 2 0

18.49 0 1.68 0

12 0 2 1

37.50 0 6.25 3.13

Risk factor

p Values 0.680 0.186 0.904 0.513 – 0.509 0.026 1.000 0.737 0.185 0.197 0.948 1.000 0.027 – 0.202 0.216

Marked with an grey shade are the p values considered statistically significant according to our study protocol.

re-intervention. The most frequent cause for a second re-intervention was a non-union (6 out of the 11 patients with a second reoperation, 54.55%). Most of these non-unions were septic (5 patients, 45.45%). The studied risk factors, their prevalence in each of the two studied groups, and calculated p values are presented in Table 1. From the studied factors, only the fracture pattern [(types B and C according to the AO/OTA system) ( p = 0.026, OR: 2.528, range: 1.117–5.721)] and alcohol abuse ( p = 0.027, OR: 2.618, range: 1.116–6.141) reached statistical significance for the need of secondary interventions. Discussion Stabilisation of tibial fractures particularly with IM nailing continues to be a topic of great interest to clinicians [11–16]. In particular, reamed IMN is considered a safe and effective surgical procedure for the management of tibial shaft fractures. Re-operation after tibial nailing has been reported to range between 12% and 44% [2]. Bhandari et al. identified open and transverse fractures as risk factors for a reoperation after tibial fracture fixation [4]. The largest multicenter, multinational, blinded, standardized, and randomized controlled trial in the literature (SPINT trial) concluded that the highenergy mechanism, stainless steel implants, full weight-bearing and fracture gaps after nailing were correlated to higher risk of negative events [8]. In this cohort the overall rate or re-intervention was 21.19% (the 32 patients that comprised the population of Group 2). The main reason for the first re-intervention was aseptic non-union and soft tissue irritation of the proximal knee (10.31%). Our data confirms that a delay in the healing process or an established non-union represent the commonest cause of a reoperation (40.63% of first re-interventions were due to septic or aseptic non-union). The most common reason for the second re-intervention was septic non-union (45%). Our study series of 151 cases revealed an overall incidence of non-union in a four-year period equal to 8.61% (13 non-unions), while the rate was higher (10.26%) if only open fractures were considered (4 cases of nonunion out of 39 open tibia fractures). In our study we identified 13 cases of re-intervention due to non-union. Of note is that the vast majority of them (8 out of 13, 61.54%) required a single reoperation to achieve union of the fracture. The aim of our study was also to identify explicit risk factors associated with increased probability of a re-intervention after tibial IMN. We documented and analysed parameters that have been previously implicated to the development of complications related to bone healing including, smoking, diabetes, complex fracture

pattern, open injuries, NSAIDS, increased alcohol consumption and compartment syndrome [17–20]. In the cohort of the patients of this study only excess alcohol consumption and complex fracture pattern (types B and C) were associated with a higher re-intervention rate. The complexity of the fracture pattern has been documented as a risk factor of adverse outcome in other studies and segmental and comminuted fractures have been known to be associated with increased risk of reoperation [21–22]. The absence of cortical continuity has also been associated with increased risk of non-union and reintervention [7]. These findings are in line which our results, which showed that in this cohort of patients the complexity of the fracture pattern (type B and C) was correlated to the re-intervention rate. Alcohol has long been known to affect the fracture healing process in tibial shaft fractures [23]. In a recent observational study alcohol was considered one of the 22 factors that were considered potential risk factors for the development of a non-union and reoperation [7]. In a retrospective observational study Schemitsch et al. identified alcohol as one of the prognostic factors for reoperation after plate fixation of the midshaft clavicle. The authors defined as excessive alcohol use the consumption of more than 15 drinks per week [24]. Alcohol abuse has also been found to be correlated with increased risk of wound complications after hip fracture surgery [24]. In line with the above studies, alcohol was found to be a risk factor for the need of a reoperation in the present cohort of patients. In the most recent Cochrane systematic review Duan et al. clearly state that the rate of re-operation for complications after tibial IMN is under-reported or difficult to be extracted even in high quality studies [1]. To the best of our knowledge the present study is one of the few in the contemporary literature that reports on the re-interventions after tibial IMN. By setting “re-interventions” as the primary outcome of our review we were able to clearly document their prevalence. Nevertheless, we are aware however that there is a number of limitations inherent to this study including its retrospective nature, different level of surgeons carrying out the operations and the relatively small number of patients recruited. Strengths of the study are the report of a single centre experience and the prospective documentation of data. Conclusion The prevalence of re-interventions of reamed IMN of the tibia in the present study was estimated to be 29.8%. Aseptic non-union and soft tissue problems around the proximal tibia are the most common

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causes for the first re-intervention whilst septic non-union is the most common cause of secondary intervention. Excess alcohol consumption and Type B and C tibial fractures have been identified as risk factors for re-interventions. The above should be considered, along with results from other studies, to inform the patients during the consultation and consent process.

[10]

[11]

[12]

Conflict of interest [13]

No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. References [1] Duan X, Al-Qwbani M, Zeng Y, Zhang W, Xiang Z. Intramedullary nailing for tibial shaft fractures in adults. Cochrane Database Syst Rev 2012;1:CD008241. [2] Bhandari M, Guyatt GH, Tong D, Adili A, Shaughnessy SG. Reamed versus nonreamed intramedullary nailing of lower extremity long bone fractures: a systematic overview and meta-analysis. J Orthop Trauma 2000;14:2–9. [3] Coles CP, Gross M. Closed tibial shaft fractures: management and treatment complications. A review of the prospective literature. Can J Surg 2000;43:256–62. [4] Bhandari MP, Tornetta P, 3rd, Sprague, Najibi S, Petrisor B, Griffith L, et al. Predictors of reoperation following operative management of fractures of the tibial shaft. J Orthop Trauma 2003;17:353–61. [5] Larsen LB, Madsen JE, Hoiness PR, Ovre S. Should insertion of intramedullary nails for tibial fractures be with or without reaming? A prospective, randomized study with 3.8 years’ follow-up. J Orthop Trauma 2004;18:144–9. [6] Lam SW, Teraa M, Leenen LP, van der Heijden GJ. Systematic review shows lowered risk of nonunion after reamed nailing in patients with closed tibial shaft fractures. Injury 2010;41:671–5. [7] Fong K, Truong V, Foote CJ, Petrisor B, Williams D, Ristevski B, et al. Predictors of nonunion and reoperation in patients with fractures of the tibia: an observational study. BMC Musculoskelet Disord 2013;14:103. [8] Schemitsch EH, Bhandari M, Guyatt G, Sanders DW, Swiontkowski M, Tornetta P, et al. Prognostic factors for predicting outcomes after intramedullary nailing of the tibia. J Bone Joint Surg Am 2012;94:1786–93. [9] Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, et al. Fracture and dislocation classification compendium - 2007: Orthopaedic Trauma Association

[14]

[15]

[16]

[17]

[18] [19] [20]

[21] [22]

[23] [24]

classification, database and outcomes committee. J Orthop Trauma 2007;21(10 Suppl): S1–133. Lavoie A, Moore L, LeSage N, Liberman M, Sampalis JS. The Injury Severity Score or the New Injury Severity Score for predicting intensive care unit admission and hospital length of stay?. Injury 2005;36:477–83. Scholz AO, Gehrmann S, Glombitza M, Kaufmann RA, Bostelmann R, Flohe S, et al. Reconstruction of septic diaphyseal bone defects with the induced membrane technique. Injury 2015;46(Suppl 4):S121–4. Tu KK, Zhou XT, Tao ZS, Chen WK, Huang ZL, Sun T, et al. Minimally invasive surgical technique: percutaneous external fixation combined with titanium elastic nails for selective treatment of tibial fractures. Injury 2015;46:2428–32. Horst K, Andruszkow H, Weber C, Dienstknecht T, Hildebrand F, Tarkin I, et al. Standards of external fixation in prolonged applications to allow safe conversion to definitive extremity surgery: the Aachen algorithm for acute ex fix conversion. Injury 2015;46 (Suppl 3):S13–8. Mathews JA, Ward J, Chapman TW, Khan UM, Kelly MB. Single-stage orthoplastic reconstruction of Gustilo-Anderson Grade III open tibial fractures greatly reduces infection rates. Injury 2015;46:2263–6. Alt V, Borgman B, Eicher A, Heiss C, Kanakaris NK, Giannoudis PV, et al. Effects of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III open tibia fractures treated with unreamed nails-A clinical and health-economic analysis. Injury 2015;46:2267–72. Shanmuganathan R, Chandra Mohan AK, Agraharam D, Perumal R, Jayaramaraju D, Kulkarni S, et al. Successful reimplantation of extruded long bone segments in open fractures of lower limb—a report of 3 cases. Injury 2015;46:1389–92. Papakostidis C, Kanakaris NK, Pretel J, Faour O, Morell DJ, Giannoudis PV, et al. Prevalence of complications of open tibial shaft fractures stratified as per the Gustilo-Anderson classification. Injury 2011;42:1408–15. Pountos I, Georgouli T, Bird H, Kontakis G, Giannoudis PV. The effect of antibiotics on bone healing: current evidence. Expert Opin Drug Saf 2011;10:935–45. Pountos I, Georgouli T, Calori GM, Giannoudis PV. Do nonsteroidal anti-inflammatory drugs affect bone healing? A critical analysis. ScientificWorldJournal 2012;2012:606404. Reverte MM, Dimitriou R, Kanakaris NK, Giannoudis PV. What is the effect of compartment syndrome and fasciotomies on fracture healing in tibial fractures? Injury 2011;42:1402–7. Giannoudis PV, Hinsche AF, Cohen A, Macdonald DA, Matthews SJ, Smith RM, et al. Segmental tibial fractures: an assessment of procedures in 27 cases. Injury 2003;34:756–62. Sen C, Kocaoglu M, Eralp L, Gulsen M, Cinar M. Bifocal compression-distraction in the acute treatment of grade III open tibia fractures with bone and soft-tissue loss: a report of 24 cases. J Orthop Trauma 2004;18:150–7. Nyquist F, Halvorsen V, Madsen JE, Nordsletten L, Obrant KJ. Ethanol and its effects on fracture healing and bone mass in male rats. Acta Orthop Scand 1999;70:212–6. Schemitsch LA, Schemitsch EH, Kuzyk P, McKee MD. Prognostic Factors for Reoperation After Plate Fixation of the Midshaft Clavicle. J Orthop Trauma 2015;29:533–7.