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JINJ 6989 No. of Pages 5

Injury, Int. J. Care Injured xxx (2016) xxx–xxx

Contents lists available at ScienceDirect

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

Risk factors for cut-out of double lag screw fixation in proximal femoral
fractures
Kadir Buyukdogana,b,* , Omur Caglara , Samet Isika , Mazhar Tokgozoglua , Bulent Atillaa
a
Hacettepe University Faculty of Medicine Department of Orthopaedics and Traumatology, Ankara, Turkey
b
Mardin Kiziltepe State Hospital, Mardin, Turkey

A R T I C L E I N F O A B S T R A C T

Article history: Objective: We assessed factors associated with cut-out after internal fixation of proximal femoral
Received 12 October 2016 fractures using double lag screw nails.
Accepted 17 November 2016 Design: Retrospective cohort study.
Setting: A university hospital.
Level of evidence: Patients and methods: Patients with non-pathological intertrochanteric femur fractures and a minumum
Prognostic level II 90 days follow-up who underwent internal fixation with dual lag screw nails were included. Potential risk
factors for lag screw cut-out investigated by our study were: age, gender, body mass index, comorbidities
Keywords:
Risk factors
(American Society of Anesthesiologists [ASA] classification), type of fracture (AO/OTA classification),
Logistic regression fracture stability, side, operation time, implant length, reduction quality, tip-apex distance (TAD), and lag
Intertrochanteric fractures screw configuration. Logistic regression was used to investigate potential predictors of screw cut-out.
Cut-out Results: Eighty-five of the 118 patients with hip fractures treated between February 2010 and November
Tip-apex distance 2013 at our institution met the inclusion criteria for the study. Fifty-eight patients were female (68.2%),
mean age was 77.4 (range: 50–95 years), mean follow up was 380 days (range: 150 days-2.5 years), and
cut of was observed in 9 patients (10.5%). The following variables identified through univariate analysis
with p < 0.2 were included in multivariant logistic regression model: age, side, reduction quality, implant
length, TAD and ASA score. Only TAD (p = 0.003) was found to be significant in the multivariant model.
Conclusions: Our study confirmed that risk factors for cut-out with single-lag screw devices are also
applicable to dual-lag screw implants. We found that TAD was a significant factor for cut-out in dual-lag
screw implants. Thus, screw cut-out can be minimized by optimizing screw position.
ã 2016 Elsevier Ltd. All rights reserved.

Introduction theoretical advantage of improved fracture fixation biomechanics


[5,6]. The use of both short and long cephalomedullary nails has
Hip fractures commonly lead to high rates of morbidity, been reported with positive clinical results [7]. Early nail designs
reduced life quality, and mortality [1]. Intertrochanteric hip were associated with a high rate of complications and reopera-
fractures account for approximately half of all hip fractures in tions, such that design modifications have been applied in recent
the elderly and the costs of care for this debilitating injury are a versions [8]. Dual-lag systems were designed to improve rotational
social and financial burden [2]. Cost of treatment increases steeply control and bony purchase within the femoral head, thus resisting
where complications occur and a previous study reported a 6.9% cut-out and subsequent fixation failure [9]. The Veronail (Veronail
rate of complications requiring a second procedure [3]. Trochanteric System, Orthofix, Bussolengo, Italy) is a novel
Current treatment options of intertrochanteric fractures intramedullary (IM) device that enables double axis sliding or
include cephalomedullary nails and compression dynamic hip locked convergent fixation of the femoral head and enables
screws [4]. Cephalomedullary nails are thought to be superior for treatment of the full range of pertrochanteric fractures with a
the treatment of unstable intertrochanteric hip fractures with the single device. Two previous studies reported outcomes with this
nail [10,11], but to the best of our knowledge, variables associated
with cut-out have not been addressed before.
Cut-out is the most common cause of fixation failure with
* Corresponding author at: Hacettepe University Faculty of Medicine Department
cephalomedullary nails and, in the literature, there is strong
of Orthopaedics and Traumatology, 06100, Sıhhıye, Ankara, Turkey.
E-mail addresses: kadirbuyukdogan@gmail.com,
evidence that fracture type, reduction, and tip-apex distance (TAD)
kadirbuyukdogan@hotmail.com (K. Buyukdogan). show associations with cut-out of lag screws from the femoral

http://dx.doi.org/10.1016/j.injury.2016.11.018
0020-1383/ã 2016 Elsevier Ltd. All rights reserved.

Please cite this article in press as: K. Buyukdogan, et al., Risk factors for cut-out of double lag screw fixation in proximal femoral fractures, Injury
(2016), http://dx.doi.org/10.1016/j.injury.2016.11.018
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JINJ 6989 No. of Pages 5

2 K. Buyukdogan et al. / Injury, Int. J. Care Injured xxx (2016) xxx–xxx

head [12–14]. Previous studies exploring mechanical and clinical (LMWH) treatment. A single dose of antibiotics was administered
factors for cut-out have used single-lag screw nails or dynamic hip within 30 min before surgery. Reduction and internal fixation were
screws. Additionally, there are concerns that the smaller diameter performed in the supine position on a fracture table using an image
screws in dual-lag designs would be more prone to migration intensifier. From the first postoperative day, the patients were
through the femoral head, thereby increasing the incidence of encouraged to walk with crutches. Patients with mild (ASA 1–2) or
screw cut-out [15]. In contrast to these concerns, recent research severe (ASA 3–5) systemic diseases were grouped using the ASA
has shown that double-screw designs provide equivalent or classification system.
greater resistance against varus collapse and neck rotation in Veronail has a design with a proximal diameter of 15 mm, distal
comparison with a single-lag screw implant [9,15]. However, there diameter of 10 mm and lengths of 200 and 280 mm. This system
is still a paucity of literature concerning predictive factors for cut- allows alternative configuration of cephalic screws, with either
out in dual-lag system implants. two parallel sliding screws or two convergent screws locked to the
The aim of this study was to assess factors that are associated nail. Lag screws were inserted as two parallel sliding screws in A1
with cut-out after internal fixation using the Veronail. In particular, fractures where the cephalic screws pass across the fracture line to
we wanted to know if reduction quality and the TAD might affect permit controlled compaction. In A3 fractures, two converging
the cut-out rate in fractures treated with Veronails. screws were used where the cephalic screws do not pass the
fracture line. A2 fractures were treated with both types of proximal
Patients and methods fixation. In both configurations, screws were fixed to nails. Lag-
screw diameter was 6.5 mm in the parallel configuration and
After approval by the local Ethics committee, all osteoporotic 5.6 mm in the convergent configuration. Highly unstable and
intertrochanteric fracture patients treated with Veronails in our comminuted fractures were fixed with the 280 mm long Veronail
institute between February 2010 and November 2013 were system.
evaluated retrospectively (n = 118). Patient records were reviewed The TAD is the sum of the distance, in milimeters, from the tip of
for age at the time of operation, gender, side of fracture, date of the screw to the apex of the femoral head, on the anteroposterior
operation, date of final clinical follow-up, fracture stability, body and lateral radiographs as described by Baumgartner et al. [12]. To
mass index (BMI), reduction quality, and American Society of assess TAD of the two screws in the AP view, we set a point in the
Anesthesiologists (ASA) scores. Exclusion criteria included patho- middle between the tips of the two screws and measured the
logical fracture and lack of radiological follow-up for at least 3 distance to the apex of the femoral head in both proximal fixation
months post-operatively. configurations [17]. In lateral view, TAD is determined as the
Both pre-operative and post-operative radiographs were distance between apex of femoral head and tip of proximal lag
reviewed by two of the authors present in the operations (KB screw (Fig. 1). The apex of the femoral head is defined as the point
and SI). Pre-operative radiographs were assesed to identify the of intersection between the subchondral bone and a line in the
type of fracture and fracture stability. The fractures were grouped center of and parallel to the femoral neck.
into classes 31.A1, 31.A2, and 31.A3 based on the Orthopedic The quality of the reduction was based on Baumgartner and
Trauma Association (OTA) classification [16]. Fractures were also Sembro [18,19]. Reduction was considered good when there was
grouped as stable (A1) or unstable (A2, A3). Immediate post- alignment (neck-shaft angle between 125 and 145 in the
operative radiographs were used to measure the quality of the anteroposterior AP view and under 20 angulation on the lateral
reduction and TAD with the use of a Picture Archiving and view) and the displacement of any fragment was 4 mm or less on
Communication System (PACS) (Centricity; General Electric Health either view. A reduction was categorized as good if both criteria
Systems, Waukesha, WI, USA). were met, and moderate if only one criterion was met. Poor
The patients were operated on within 3 days of admission. All reductions met neither criteria. Assessment of reduction quality
patients received prophylactic low-molecular-weight heparin and TAD measurements were performed using the X-ray films that

Fig. 1. In the AP view, to measure Xap we set a point in the middle between the tips of the two screws and measured the distance to the apex of the femoral head. Measured
diameter of the lag screw on an AP view is Dap. In lateral view, to measure Xlat we set a point at the tip of screw and measured the distance to the apex of the femoral head.
Measured diameter of the lag screw on an lateral view is Dlat.

Please cite this article in press as: K. Buyukdogan, et al., Risk factors for cut-out of double lag screw fixation in proximal femoral fractures, Injury
(2016), http://dx.doi.org/10.1016/j.injury.2016.11.018
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were obtained immediately after the operation by two of authors postoperatively and were excluded. Two patients suffered from
(KB and SI) blinded to each other’s measurements. nonunions and underwent internal fixation with an other intra-
medullary device. One patient received iv antibiotic theraphy and
Statistical analysis debridment because of superficial infection. Lag screw brekage
was observed in one patient and excluded from study. Thus, 85
Statistical analyses were performed with SPSS for Windows patients with 85 hip fractures were suitable for our study (Table 1).
software (ver. 17.0; SPSS Inc., Chicago, IL, USA). The x2 test and There were 58 women (69%) and 27 men (31%). Their mean age was
binary logistic regression were used for univariate analyses of the 77.0  9.6 years. The mean follow-up time was 380  36 days.
categorical and continuous parameters. The independent variables
from the univariate analysis with a p value of <0.20 were entered Statistical analysis
in a multivariate analysis with the occurrence of cut-out as the
dependent variable. We assessed any factor in the multivariate Cut-out was observed in nine (10.5%) patients during the study
model as significant if the corresponding p value was <0.05. The period. Among them, cut-out occurred within 3 months after the
likelihood ratio backward test was conducted to find the best-fit operation in five patients and after the third postoperative month
model by selecting variables one by one. The probability for entry in four. No statistically significant difference was found in gender
was set at p < 0.05 and removal at p > 0.10. We performed the (p = 0.923), BMI (p = 0.253), operation time (p = 0.202), or type of
Hosmer and Lemeshow goodness-of-fit test to assess the logistic lag screw configuration (p = 0.723) between the two groups. Cut-
regression model fit to the data. out was more frequent in unstable fractures, but differences in
To assess interobserver reliability, the intraclass correlation fracture stability (p = 0.727) and AO fracture classification
coefficient (ICC) was calculated using a two-way random effects (p = 0.479) between groups were also not significant.
model with 95% confidence intervals (95% CI). To assess the In the univariate logistic regression model, seven potential risk
interobserver reliability of categorical data, kappa coefficients factors turned out with p values below the threshold of 0.2,
were calculated using 95% CIs. including the variables implant length, side of fracture, moderate
and poor reduction, TAD, age, and ASA. All the p values together
Results with their corresponding CIs and odds ratios are presented in
Table 1.
In total, 118 patients who had had intertrochanteric hip To assess the interobserver reliability of continuous parameters
fractures and underwent fixation using Veronails between turned out with p < 0.2 in univariate analysis, the intraclass
February 2010 and November 2013 were identified. Ten patients correlation coefficient and k coefficient were calculated. The ICC
died within 3 months after surgery and were excluded. Five was calculated to assess the interobserver reliability of TAD
patients with pathological hip fractures were excluded. Fourteen measurement and k coefficient was calculated for the interob-
patients did not have a complete follow-up at 3 months server reliability of Baumgartner’s classification. The ICC of TAD

Table 1
Univariate Analyses.

Factor Total No cut-out (n = 76) Cut-out (n = 9) p value OR 95% CI for OR


Agea (years) 77.8  9.6 77.5  9.8 73.8  7.8 0.155 0.963 0.900–1.031
Genderb 1.000 0.923 0.213–4.006
Male 27 (31%) 24 (88%) 3 (12%)
Female 58 (69%) 52 (89%) 6 (11%)
Operation timea (min) 73.8  20.7 72.6  20.1 83.9  24.6 0.202 1.025 0.993–1.057
BMIa (kg/m2) 27.3  5.0 27.1  4.9 29.3  5.8 0.253 1.087 0.951–1.242
Sideb 0.170 3.321 0.648–17.025
Right 46 (54%) 39 (84.8%) 7 (15.2%)
Left 39 (46%) 37 (94.9%) 2 (5.1%)
ASA groupb 0.124 3.274 0.801–13.378
(1,2) 59 (69%) 55 (93.2%) 4 (6.8%)
(3–5) 26 (31%) 21 (80.8%) 5 (19.2%)
AO classificationb 0.479 undefined
31.A1 36 (42.4%) 33 (91.7%) 3 (8.3%)
31.A2 34 (40%) 31 (91.2%) 3 (8.8%)
31.A3 15 (17.6%) 12 (80%) 3 (20%)
Fracture stabilityb 0.727 1.535 0.357–6.658
Stable 36 (43.9%) 33 (91.7%) 3 (8.3%)
Unstable 49 (56.1%) 43 (87%) 6 (13%)
Implant lengthb 0.068 4.929 1.006–24.146
Short 75 (88.2%) 69 (92%) 6 (8%)
Long 10 (11.8%) 7 (70%) 3 (30%)
Lag screw configurationb 0.723 1.37 0.34–5.53
Parallel 53 (62.4%) 48 (90.6%) 5 (9.4%)
Convergent 32 (37.6%) 28 (87.5%) 4 (12.5%)
TADa (mm) 1.97  4.8 18.9  4.2 26.5  4.8 <0.001 1.328 1.129–1.562
Reductionb 0.071 undefined
Good 38 (44.7%) 37 (97.4%) 1 (2.6%)
Moderate 35 (41.1%) 29 (82.9%) 6 (17.1%)
Poor 12 (14.2%) 10 (83.3%) 2 (16.7%)
a
Values are provided as means plus standard deviation.
b
values are given as the number of patients, with percentage in parentheses. OR, odds ratio; CI, confidence interval; BMI, body mass index; ASA, American Society of
Anesthesiologists; TAD, tip-apex distance.

Please cite this article in press as: K. Buyukdogan, et al., Risk factors for cut-out of double lag screw fixation in proximal femoral fractures, Injury
(2016), http://dx.doi.org/10.1016/j.injury.2016.11.018
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Table 2 wanted to investigate the influence of TAD and the classification


Multivariate Analysis.
system of Baumgaertner in fracture reduction. To the best of our
Factor p value OR 95% CI for OR knowledge, the influence of these factors on cut-out rates in
Age 0.374 patients undergoing internal fixation with Veronail dual lag screw
Side 0.051 device has not been reported before.
Implant length 0.374 TAD was described by Baumgaertner et al. and was considered a
ASA 0.123
major risk factor for cut-out of the implant [12]. Previous studies
Reduction
Moderate 0.045 59.8 1.09–3265.9
reported the TAD of intramedullary devices as a predictor of cut-
Poor 0.216 out failure in the treatment of intertrochanteric fractures
TAD 0.003 1.623 1.179–2.235 [14,22,23]. Our study confirmed that TAD is a predictor of cut-
OR, odds ratio; CI, confidence interval; ASA, American Society of Anesthesiologists out in dual-lag systems (OR = 1.62, 95% CI: 1.17–2.23, p = 0.003). As
classification system; TAD, tip-apex distance. the Veronail has a dual-lag screw, we used the method described
by Schmidt-Rohlfing. In their studies, they mentioned that, by
inserting two cephalic screws into the femoral head, a greater TAD
Table 3
can be generally expected [17]. However, in our study, the overall
Reliability Between the Two Observers for Different Variables.
mean TAD was 19.7 4.8 mm, consistent with previously reported
Variable ICC (k) 95% CI values [14,29]. This result may be because we were already aware
TAD (ICC) 0.909 0.864–0.940 of the importance of the TAD. Although earlier studies showed that
Fracture Reduction (kappa) 0.884 0.838–0.960 patients who had a TAD >25 mm were at risk of screw cut-out,
ICC, intraclass correlation coefficient; CI, confidence interval; TAD, tip-apex recent studies suggest that lower thresholds would be effective in
distance. reducing the risk of cut-out [29]. We observed that the patients
whose TAD values were <21.7 mm did not needed any reoperation.
measurements was 0.909 (95% CI, 0.864–0.940) and the k Although performed with dual lag screw implants, our findings
coefficient of the reduction system was 0.884 (95% CI, 0.838– confirm previous studies finding high TAD values to be a significant
0.960), both indicating good reliability (Table 3). predictor of cut-out of IM nails [14,23]. However, our TAD distances
In the multivariate logistic regression, variables with p < 0.2 in were for a dual lag screw system and therefore research with larger
the univariate model were analyzed (Table 2). Statistical differ- study groups is needed to obtain more reliable results.
ences were found in TAD (odds ratio (OR) = 1.62, 95% confidence Our study showed that beyond TAD, there was association
index (CI): 1.17–2.23, p = 0.003) and moderate reduction (OR = 59.8, between moderate reduction and cut-out (OR = 59.8, 95% CI: 1.09–
95% CI: 1.09–3265.9, p = 0.045). Other parameters found between 3265.9, p = 0.045), but poor reduction was not associated with cut-
the groups in the univariate analysis were no longer significant. out (p = 0.216). We interpret this finding with caution because
The Hosmer and Lemeshow goodness-of-fit test indicated that the confidence interval of this association was too wide. A wide
model fitted the data very well (p = 0.749). confidence interval indicates that we are less sure and the
conclusion is less certain. The size of the confidence interval
Discussion depends on the sample size and here is an inverse square root
relationship between confidence intervals and sample sizes. We
Intertrochanteric hip fractures account for approximately half believe that this finding was due to the small sample size and we
of all hip fractures and the cost of treatment increases steeply cannot say that poor reduction is not of concern, especially because
where complications occur in with injury [2,20]. Current treatment previously published reports indicated that a poor reduction of
options include sliding hip screws and nails, and there has been a these fractures was associated with more complications [30,31].
trend towards increased use of IM fixation [21]. Even with Baumgaertner et al. reported that fractures with poor reductions
improvements in the implants and techniques used to manage were more than three times as likely to progress to cut-out than
these fractures, failures continue to occur. Cut-out is the most fractures with good reductions [12]. Suboptimal osteosynthesis
common cause of failure in IM fixation [12,14]. To prevent a second was also shown to be associated with cut-out in Lobo-Escobar’s
procedure, many studies reported the importance of technique study [14]. Kashigar et al. did not find a correlation between
variables, such as TAD, reduction quality, and implant positioning reduction accuracy and failure of cephalomedullary nails [23]. It
in cut-out [14,22,23]. Dual-lag systems were designed to improve might be argued that reduction criteria are subjective evaluations
rotational control and bony purchase within the femoral head, thus based on interpretation [14,29]. However, in our study, these
resisting cut-out and subsequent fixation failure. Kubiak et al. criteria showed high intraobserver reliability, which can be
compared the stability of one and two lag screw implants used in explained by the fact that measurements were performed by
the fixation of unstable intertrochanteric fractures. They have two consultant trauma surgeons. It is well known that sub-optimal
found that single and dual lag screw implants demonstrated a reduction produces poor results in hip fracture management [32].
significantly different migration resistance under gait loading We believe larger study groups are needed to confirm whether
stimulation in their biomechanical study. The dual screw construct reduction quality contribute significantly to cut-out in dual lag
provided significantly greater resistance against varus collapse and screw implants.
neck rotation in comparison to a single lag screw devices [9]. Our study had several limitations. First, it used a retrospective
However, in the clinical setting, these biomechanical advantages design and thus had all of the drawbacks associated with that
failed to decrease complication rates [24,25]. Additionally, unique method; furthermore, we had a limited sample size because of a
types of failure, namely the Z effect and reverse Z effect high rate of absenteeism. In total, 85 of the 118 fractures met the
phenomena, have been recognized in fractures fixed with these inclusion criteria for the study with at least 3 months of follow-up.
devices [26–28]. The Z effect and reverse Z effect are described as This situation can be explained by the relatively old age of the
the opposite migrations of lag screws. Although these phenomena patient population. We did not include radiographic osteoporosis
are not of concern in the current study, two of the cut-outs index as a variable in our study, because the Singh index has high
occurred due to a reverse Z effect. intra- and interobserver disagreement and we believe that dual-
The aim of this study was to assess factors associated with cut- energy X-ray absorptiometry might be a more objective way of
out after internal fixation using the Veronail. In particular, we assessing any association between cut-out and osteoporosis

Please cite this article in press as: K. Buyukdogan, et al., Risk factors for cut-out of double lag screw fixation in proximal femoral fractures, Injury
(2016), http://dx.doi.org/10.1016/j.injury.2016.11.018
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JINJ 6989 No. of Pages 5

K. Buyukdogan et al. / Injury, Int. J. Care Injured xxx (2016) xxx–xxx 5

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Please cite this article in press as: K. Buyukdogan, et al., Risk factors for cut-out of double lag screw fixation in proximal femoral fractures, Injury
(2016), http://dx.doi.org/10.1016/j.injury.2016.11.018

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