Abstract
Purpose
-
The purpose of this study was to investigate differences in aseptic reoperation rates between single or dual lag screw femoral nails,in the treatment of intertrochanteric fractures (ITF) in elderly patients.
Methods
-
Electronic databases were searched for RCTs and prospective cohort studies treating elderly ITF patients with a single or dual screw femoral nails. Data for aseptic reoperation rates between single screw, dual separated screw and dual integrated screw devices were pooled using a random-effects meta-analysis with 95% CIs. Pooled proportions were compared using a N-1 chi-squared test. Complications contributing to aseptic reoperation rates were extracted, and the contribution of cut-out and periprosthetic fracture as a proportion of reoperations was analysed using a negative binomial regression model.
Results
-
Forty-two (n = 42) studies were evaluated, including 2795 patients treated with a single screw device, 1309 patients treated with a dual separated screw device and 303 patients treated with a dual integrated screw device. There was no significant difference in aseptic reoperation rates between single and dual lag screw femoral nails of both separated and integrated lag screw designs. Moreover, complications of cut-out and periprosthetic fracture as a proportion of reoperations did not differ significantly between devices.
Conclusion
-
The current evidence showed that aseptic reoperation rates were not significantly different between single and dual screw nails of a separated lag screw design. For dual integrated screw devices, due to insufficient evidence available, further high quality RCTs are required to allow for decisive comparisons with these newer devices.
Introduction
Proximal femur fractures are one of the most prevalent injuries among the elderly. There were approximately 1.66 million fractures globally in the year 2000 and a projected 2.6 million worldwide by 2025 (1, 2). Intertrochanteric fractures (ITF), accounting for approximately half of all hip fractures (3), are treated using intramedullary femoral nails with increasing frequency (4, 5, 6). While the principles of ITF stabilization via femoral nailing remain consistent, design variations exist between manufactures, a major point of difference being the configuration of the lag screw.
Currently, the lag screw configuration of a femoral nail falls predominantly into three main design types: single screw, dual screw and ‘helical blade’ nails (7). Dual screw devices can then be categorized as separated lag screw devices, where two lag screws function independently of one another, and integrated lag screw devices, where two lag screws are mechanically integrated to one another. Outcomes after nailing of ITF are determined by a multitude of factors (8, 9, 10); however, the effect of lag screw configuration between single and dual screw devices on fixation failure remains unclear. Given this lack of evidence and consensus in outcomes relating to a key design component of implants on the market, a critical question is raised. Is there a difference in aseptic reoperation rates between femoral nails comprising of a single or dual lag screw design in the management of ITFs? Moreover, is there a difference between separated dual screw and integrated dual screw devices? This systematic review and meta-analysis aim to address this question through the analysis of prospective randomized controlled trials (RCTs) and cohort studies.
Materials and methods
Protocol and registration
This systematic review and meta-analysis were registered with the International Prospective Register of Systematic Reviews and conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
A search of electronic databases including Pubmed (MEDLINE), Embase, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials (CENTRAL) was completed on 20 September 2020, with no restriction on publication date. The search strategy was developed using the PICO framework and included free text and subject headings (MeSH for MEDLINE (PubMed), CINAHL and CENTRAL, Emtree for Embase) relating to hip fractures and their treatment via femoral nailing. The following search strategy was used: (((’hip fractures’[MeSH Terms] OR ((hip[tiab] OR proximal femur[tiab] OR intertrochant*[tiab] OR trochant*[tiab] OR pertrochant*[tiab] OR extracapsular[tiab]) AND fracture*[tiab]))) AND (’fracture fixation, internal’[MeSH Terms] OR ‘internal fixators’[MeSH Terms] OR internal fixation[tiab] OR cephalomedullary nail*[tiab] OR femoral nail*[tiab] OR trochanteric nail*[tiab] OR intramedullary nail*[tiab] OR internal fixat*[tiab] OR nail*[tiab]) AND (’reoperation’[MeSH Terms] OR ‘equipment failure’[MeSH Terms] OR ‘treatment outcome’[MeSH Terms] OR reoperat* OR revis* OR re operat* OR cut-out OR ‘cut out’)). The reference lists of articles deemed eligible were also manually searched for additional eligible articles.
Study inclusion
Eligible studies were included if they: (1) were prospective cohort studies; (2) only included adults ≥ 60 years with ITFs; (3) single or dual screw femoral nail was used to manage the fracture in at least one group; (4) included at least 30 cases in the treatment group; (5) patients were followed up for at least 3 months after surgery; (6) reoperation rates were reported and (7) articles published in English. Studies were excluded if they: (1) were retrospective; (2) included patients with other lower limb pathologies; (3) included patients with subtrochanteric or basicervical fractures only; (4) treated patients with a helical blade femoral nail solely in all groups; (5) analysed data from another study already included or; (6) did not provide data describing aseptic reoperation rates. Articles were reviewed against the eligibility criteria independently by two reviewers, in two stages, where the assessed eligibility was blinded. First, titles and abstracts from the initial search were assessed after which discrepancies were resolved through discussion. Where an agreement was still unable to be reached, a third researcher was asked to comment. Full texts were then obtained for the studies passing the initial eligibility screening and assessed for eligibility using the same approach with disagreements discussed to reach a consensus.
Quality assessment
Quality assessment of the studies was conducted using the Cochrane Risk of Bias 2 (RoB 2) tool for RCTs and the Downs and Blacks tool for non-randomized cohort studies. The Downs and Black was selected for its reliability and validity in assessing the quality of non-randomized studies (11). Previous studies have implemented a modified version of the tool where the statistical power question was given a single point when evidence of a power calculation was conducted rather than scoring based on a range of study powers (12, 13). This resulted in a total score for the tool of 28 as opposed to the original 32. From the numerical score for each study, an overall quality level of excellent (26–28), good (20–25), fair (15–19) or poor (≤14) was then assigned, as adapted from previous literature (14, 15). For this review and meta-analysis, studies of low quality were not excluded from the analysis.
Data extraction
Data were extracted by a single author from each included study using an extraction tool developed through consensus agreement with the other authors (Table 1). We extracted data relating to patient demographics, device used, fracture type, aseptic reoperation rate and reasons for reoperation. For studies with multiple groups, where a different device was used in each treatment group, only data relevant to the cohort(s) treated with a single or dual screw femoral nail were extracted. For the meta-analysis, the results were categorized into single screw devices or dual screw devices, with the dual screw data further divided into separated or integrated dual screw devices. For nails that by design, can be used as either single or dual screw devices, devices were categorized respective of whether they were used as a single or dual screw device. If there was any ambiguity, the corresponding author was contacted for the data.
Characteristics of the included studies.
| Reference | Femoral nail lag screw type | Cases | Age (s.d.) | Fracture type | Follow-up (months) | Aseptic reoperations | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Single | Dual (S) | Dual (I) | Total | Male | Female | Stable | Unstable | ||||
| Aktselis et al. (20) | Gamma nail | 36 | 8 | 28 | 82.9 (5.8) | 0 | 36 | 12 | 0 | ||
| Babar et al. (21) | Proximal femoral nail | 62 | 23 | 39 | 74.27 (5.84) | 0 | 62 | 6 | 5 | ||
| Bonnevialle et al. (22) | Gamma nail | 113 | 83 | 30 | 85.5 (NR) | 0 | 113 | 6 | 8 | ||
| Borger et al. (23) | Targon PFT nail | 37 | 14 | 23 | 77.7 (NR) | 0 | 37 | 12 | 1 | ||
| Bridle et al. (24) | Gamma nail | 49 | 9 | 40 | 81 (NR) | 18 | 31 | 6 | 7 | ||
| Buecking et al. (25) | Gamma nail | 79 | NR | NR | NR | 32 | 47 | 12 | 2 | ||
| Buecking et al. (26) | Gamma nail, Zimmer natural nail | 188 | 58 | 130 | 82 (8) | NR | NR | 12 | 9 | ||
| Caiaffa et al. (27) | Endovis BA nail | 266 | 93 | 173 | 78.1 (7.2) | 85 | 181 | 12 | 8 | ||
| Catania et al. (28) | Gamma nail | 168 | 55 | 113 | 85.7 (5.48) | 27 | 141 | 12 | 11 | ||
| Chinzei et al. (29) | Gamma nail | 59 | 16 | 43 | 82.7 (11.2) | 26 | 33 | 6 | 1 | ||
| Ciaffa et al. (30) | Endovis BA2 nail | 212 | 138 | 74 | 76.6 (2.6) | 71 | 141 | 12 | 11 | ||
| Dong et al. (31) | Gamma nail | 89 | 48 | 41 | 70.7 (2.8) | 25 | 64 | 6 | 4 | ||
| Efstathopoulos et al. (32) | Gamma nail | 56 | 19 | 37 | 79.5 (NR) | 12 | 44 | 8 | 0 | ||
| Dual (S) | 56 | 13 | 43 | 78.1 (NR) | 8 | 48 | 8 | 0 | |||
| Foulongne et al. (33) | BCM nail | 30 | 3 | 27 | 85.5 (7.9) | 22 | 8 | 3 | 0 | ||
| Giessauf et al. (34) | Gamma nail | 65 | 13 | 49 | 80 (10) | 27 | 38 | 12 | 2 | ||
| Hardy et al. (35) | IMHS | 50 | 8 | 42 | 81.7 (11.8) | 16 | 34 | 12 | 3 | ||
| Harrington et al. (36) | IMHS | 50 | 10 | 40 | 83.8 (8.5) | 0 | 50 | 12 | 2 | ||
| Hopp et al. (37) | Gamma nail | 39 | 13 | 26 | 80.73 (8.44) | 0 | 39 | 6 | 1 | ||
| Intertan | 39 | 7 | 32 | 82.7 (7.06) | 0 | 39 | 6 | 2 | |||
| Ito et al. (38) | Gamma nail | 177 | 29 | 148 | 84 (NR) | 96 | 81 | 5.2 | 9 | ||
| Jolly et al. (39) | Proximal femoral nail | 50 | NR | NR | 81.2 (7.8) | 0 | 50 | 12 | 6 | ||
| Karakus et al. (40) | Antirotation proximal femur nail | 54 | 11 | 43 | 79.28 (9.54) | 0 | 54 | 12 | 3 | ||
| Kim et al. (41) | Intertan | 100 | 35 | 65 | 77.8 (9.1) | 12 | 88 | 12 | 3 | ||
| Kouvidis et al. (42) | Endovis BA nail | 86 | 18 | 72 | 81.95 (7.21) | 26 | 60 | 12 | 7 | ||
| Lanzetti et al. (43) | Supernail GT | 143 | 24 | 119 | 85.01 (8.27 | 73 | 70 | 3 | 4 | ||
| Lin et al. (44) | Double screw nail | 144 | 41 | 103 | 78 (9.1) | 51 | 93 | 12 | 6 | ||
| Mavrogenis et al. (45) | Veronail Trochanteric nail | 79 | 18 | 61 | 84.7 (NR) | 45 | 34 | 12 | 1 | ||
| Mavrogenis et al. (46) | IMHS | 110 | 35 | 75 | 78 (NR) | 31 | 79 | 14 | 1 | ||
| Miedel et al. (47) | Gamma nail | 93 | NR | NR | NR | 0 | 93 | 12 | 3 | ||
| Papasimos et al. (48) | Gamma nail | 40 | 16 | 24 | 82.8 (NR) | 0 | 40 | 12 | 3 | ||
| Proximal femoral nail | 40 | 17 | 23 | 79.4 (NR) | 0 | 40 | 12 | 5 | |||
| Park et al. (49) | Gamma nail (Asia Pacific) | 30 | 10 | 20 | 73.7 (NR) | 14 | 16 | 12 | 1 | ||
| Schipper et al. (50) | Gamma nail | 213 | 37 | 17 | 82.2 (8.4) | 0 | 213 | 12 | 19 | ||
| Proximal femoral nail | 211 | 38 | 173 | 82.6 (8) | 0 | 211 | 12 | 28 | |||
| Shin et al. (51) | Zimmer natural nail | 172 | 63 | 109 | 76.22 (16.4) | 44 | 128 | 12 | 6 | ||
| Su et al. (52) | Gamma nail | 50 | 19 | 31 | 71. 3 (8.7) | 0 | 50 | 12 | 5 | ||
| Intertan | 50 | 21 | 29 | 70.1 (9.2) | 0 | 50 | 12 | 1 | |||
| Vaquero et al. (53) | Gamma nail | 30 | 5 | 25 | 83.5 (7.4) | 0 | 30 | 12 | 4 | ||
| Varela-Egocheaga et al. (54) | Gamma nail | 40 | 6 | 34 | 82.5 (NR) | 27 | 13 | 12 | 3 | ||
| Vidyadhara et al. (55) | Gamma nail | 37 | 19 | 18 | 68.6 (5.6) | 0 | 37 | 24 | 1 | ||
| ACE nail | 36 | 18 | 18 | 69.4 (4.6) | 0 | 36 | 24 | 0 | |||
| Wu et al. (56) | Gamma nail | 174 | 43 | 131 | 72.6 (8.6) | 0 | 174 | 12 | 5 | ||
| Intertan | 87 | 20 | 67 | 71.4 (9.7) | 0 | 87 | 12 | 2 | |||
| Wu et al. (57) | Gamma nail | 169 | 74 | 95 | 74.27 (5.84) | 64 | 105 | 12 | 14 | ||
| Xu et al. (58) | Gamma nail | 70 | 27 | 43 | 75.4 (1.0) | 0 | 70 | 12 | 1 | ||
| Yang et al. (59) | Gamma nail | 124 | 38 | 86 | 81.6 (NR) | 21 | 103 | 12 | 1 | ||
| Yao et al. (60) | Proximal femoral nail | 30 | 14 | 16 | 77.4 (5.6) | 8 | 22 | 12 | 0 | ||
| Yaozeng et al. (61) | Gamma nail | 52 | 15 | 37 | 21 | 31 | 12 | 0 | |||
Dual (I), dual integrated; Dual (S), dual separated; NR, not reported.
Reported reasons for reoperation were extracted from each study with the authors original terminology and similar terms (e.g. periprosthetic fracture and diaphyseal fracture) combined by a senior orthopaedic surgeon. Where data were not reported, the corresponding author was contacted for the relevant information. Complications that described similar mechanisms of failure but reported separately in papers were not combined and analysed separately (e.g. medial protrusion of lag screw and cut-out). Studies where data were unable to be obtained for the number of ITFs managed with a single or dual screw femoral nail within a single device group, and respective number of aseptic reoperations, were excluded from the meta-analysis.
Statistical analysis
A random-effects meta-analysis model was used to calculate pooled proportions and 95% CIs of reoperations within the respective device types; single screw, dual screw, dual (separated) screw, and dual (integrated) screw devices (16). Pooled proportions were then compared using a N-1 chi-squared test (17, 18). In a fixed-effect analysis, true effect size is assumed to be the same in all studies and the summary effect provides an estimate of this common effect size. In a random-effects analysis, the true effect size is assumed to vary between each study with the studies in the analysis representing a random sample of effect sizes that could be observed. The summary effect is an estimate of the mean of these effects (19).
The contribution of cut-out and periprosthetic fracture to the number of reoperations was analysed within each device type using a negative binomial regression model adjusting for offset of the natural logarithm of the number of reoperations. The statistical package used for the primary meta-analysis was Stata Statistical Software (Release 16; StataCorp LLC, College Station, TX, USA). Analysis of the reasons for reoperation was conducted in IBM SPSS Statistics for Windows (version 27; IBM Corp.).
Results
Totally 5330 articles were identified from the initial search, of which 42 studies were included in the meta-analysis (Fig. 1) (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61).
Flowchart summarizing study identification and selection of included studies.
Citation: EFORT Open Reviews 7, 7; 10.1530/EOR-21-0067
Qualitative synthesis
From the included studies (n = 42), data for 4434 patients sustaining an ITF and managed with either a single or dual screw femoral nail were extracted. Studies reported a mean follow-up time of 10.8 months (range: 3–24). Studies reporting treatment of patients with a single screw device were most commonly reported in the literature, followed by dual separated screw devices. The assessment of quality and risk of bias of the included studies indicated moderate quality overall. For the assessment of cohort studies, the rating was good (7/18), fair (10/18) and poor (1/18). For the assessment of RCTs, the overall risk of bias was judged as low risk (4/24) and some concerns (20/24), with zero studies judged high risk (0/24). Only 5 of the 42 studies were funded by an orthopaedic implant company. Historical trends of reported device use over time are illustrated in Fig. 2 and show the introduction of each device type and the scale of use in clinical studies.
Historical trends of reported femoral nails use in prospective RCTs and cohort studies over time.
Citation: EFORT Open Reviews 7, 7; 10.1530/EOR-21-0067
Quantitative synthesis
From included studies (n = 42), there were 2795 patients treated with a single screw device with a mean age of 80.1 years (range: 68.6–85.7), and 1639 patients treated a dual screw device with a mean age of 77.8 years (range: 69.4–84.7). Divided into dual separated screw and dual integrated screw devices, there were 1309 patients with a mean age of 78.4 (range:, 69.4–84.7) and 330 patients with a mean age of 76.3 (range: 70.1–77.8), respectively. Heterogeneity between studies was estimated using the I-squared statistic and Cochrane’s Q P value. There was moderate heterogeneity for studies that looked at single screw devices (I2 = 39.4%, P = 0.014), dual screw devices (I2 = 53.9%, P = 0.003) and dual separated screw devices (I2 = 66.3%, P < 0.001). There was no indication of heterogeneity in studies that looked at dual integrated screw devices (I2 = 0%, P = 0.909). As random-effects model was used in the analysis, the degree of heterogeneity is less relevant.
Reoperation rates
The aseptic reoperation rate for single screw devices was calculated to be 3% (95% CI: 2%, 4%) (Fig. 3). For dual separated screw nails and integrated screw nails, the aseptic reoperation rate was 4% (95% CI: 2%, 7%) and 3% (95% CI: 1%, 5%), respectively (Fig. 3). The pooled proportion of aseptic reoperations in all dual screw devices (separated and integrated devices combined) was calculated to be 4% (95% CI: 2%, 6%).
Aseptic reoperation rates in patients treated with a single screw, dual separated screw and dual integrated screw femoral nail calculated using a random-effects meta analysis.
Citation: EFORT Open Reviews 7, 7; 10.1530/EOR-21-0067
The aseptic reoperation rate was 1% higher for all dual screw devices compared to single screw designs (95% CI: 0%, 2%, P = 0.075). However, this difference was not statistically significant. Similarly, there was no significant difference in aseptic reoperation rates between dual separated screw devices and single screw devices (95% CI: 0%, 2%, P = 0.096).
Reasons contributing to aseptic reoperation
The mechanisms of failure contributing to reoperation varied between device types, with dual separated screw devices exhibiting several mechanisms of failure that were not reported to occur in single or dual integrated screw devices in the studies analysed (e.g. lag screw breakage, z-effect/reverse z-effect, medial protrusion of the lag screw and avascular necrosis of the femoral head). Moreover, for dual integrated screw devices, cut-out and periprosthetic fracture were the only reported contributing mechanisms to aseptic reoperation. For single screw and dual separated screw devices, cut-out, periprosthetic fracture and lag screw backout were the highest reported contributing mechanisms to aseptic reoperation rates. The contribution of lag screw backout to reoperations could only be compared for single and dual separated screw devices.
For single screw devices, the rates of cut-out and periprosthetic fracture requiring reoperation were 1.3% (95 CI: 1%, 2%) and 0.3% (95% CI: 0%, 1%), respectively. For all dual screw devices, the rate of cut-out was 1.4% (95 CI: 0%, 2%) and 0.3% (95% CI: 0%, 1%) for periprosthetic fracture. Further dividing dual screw devices, the incidences of cut-out and periprosthetic fracture were 1.2% (95% CI: 0%, 2%) and 0.3% (95% CI: 0%, 1%) for dual separated screw devices and 2.7% (95% CI: 0%, 5%) and 0.4% (95% CI: 0%, 2%) for dual integrated screw devices. The rate of lag screw backout requiring reoperation was 0.1% (95% CI: 0%, 1%) for single screw devices and 0.3% (95% CI: 0%, 1%) for dual separated screw devices.
As a proportion of aseptic reoperations, there was no statistically significant association between device type and cut-out (P = 0.442). There was also no association between device type and periprosthetic fracture contributing to aseptic reoperation rates (P = 0.916). Similarly, the contribution of lag screw backout to reoperations did not differ significantly between single and dual separated screw devices (P = 0.255). Reported mechanisms contributing to reoperation per 1000 cases for each device are shown in Fig. 4.
Reasons contributing to reoperation per device type in 1000 cases.
Citation: EFORT Open Reviews 7, 7; 10.1530/EOR-21-0067
Discussion
Fixation of ITFs in elderly patients using femoral nails is a procedure which is becoming increasingly common (4, 6, 62, 63). Despite the wide use of these devices in current practice, the effect of the lag screw configuration on aseptic reoperation rates in elderly ITF patients remains unclear. Hence, it was the aim of this review and meta-analysis to identify whether differences in reoperation rates exist between single and dual screw devices. Our review identified 42 studies reporting single and dual screw devices that met inclusion criteria. The results showed that there was no significant difference in aseptic reoperation rates between single screw (3%) and dual separated screw (4%) femoral nail designs. When considering dual integrated devices, rates of reoperation were equal to those of the single screw devices (3%); although due to the limited number of cases (n = 330) managed using the dual integrated devices, there is insufficient current evidence to make decisive comparisons between these devices.
Femoral nailing is commonly associated with a number of complications relating to the mechanics of osteosynthesis and the type of nail used (64). Our meta-analysis highlighted that cut-out of the lag screw is the largest contributing mechanism to aseptic reoperation rates, followed by backout of the lag screw and periprosthetic fracture for both single and dual screw femoral nails. Our results showed that the difference in cut-out and periprosthetic fracture contributing to aseptic reoperation rates between devices did not differ significantly. From the data available, we could not test the contribution of lag screw backout to aseptic reoperations between all three device types;however, there was no significant difference between single and dual separated screw devices. In a meta-analysis by Norris et al. (65) evaluating secondary fracture with uniaxial nails (single screw, pin or helical blade) and biaxial nails (two separated screws, pins or helical blades), they found there was a lower risk of periprosthetic fracture with biaxial devices compared with uniaxial screw devices. No other complications and mechanisms of failure were reported. Although the results from our study did not support this difference in periprosthetic fracture between single and dual screw devices, this may be due to the inclusion of helical blade devices into the uniaxial nail group (66, 67).
Limitations
Our review identified and included numerous studies assessing treatment using single (n = 31 studies, 2795 patients) and dual separated screw devices (n = 13 studies, 1309 patients); there were far fewer studies reporting patients treated with dual integrated screw devices (n = 5 studies, 330 patients). Due to such disparity, it is not possible based on current evidence to make any decisive conclusions relating to dual integrated screw devices. Further research is required to evaluate their performance. Secondly, this study included prospective RCTs and prospective cohort studies where at least one cohort of patients were treated with a single or dual screw femoral nail. The data from these cohorts were combined in one analysis, and we acknowledge the challenges of aggregation of data (68). The use of reoperation rates as an endpoint has some inherent flaws, as the reasons for reoperation are often affected by multiple factors which are not reported; as an outcome measure, it also fails to pick up cases where the device construct has failed but patients are not suitable for complex revision surgery. Fracture reduction is rarely reported on, despite being strongly linked to mechanical complications. A poor fracture reduction may negatively affect construct stability and is therefore likely to increase particular failure modes, in particular lag screw cut-out. Positioning of the lag screw within the femoral head has also been linked to construct stability. In particular, positioning of the tip of the lag screw in the Cleveland peripheral zones (69) and a Tip-Apex Distance (TAD) (70) of over 25 mm (71) has been correlated with increased risk of cut-out. These measures are infrequently reported alongside reoperation rates.
Femoral nails can be used in unlocked or locked modes of the proximal lag screw. Some device manufactures suggest the device be used in the dynamic mode as per the operative technique guide, while other manufacturers leave this decision to the operating surgeon. Of the included studies, no study mentioned whether the lag screw was locked or unlocked.
Finally, the papers included span a large time period from 1991 to 2020. During this time, there were numerous design changes to devices, and few intramedullary nails have remained unchanged throughout. We believe however that the majority of design changes that have occurred have been relatively minor, with the exception of the Gamma nail, which changed from gamma2 to gamma 3 in 2004, aiming to reduce nail breakage, which is a rare cause for reoperation. Our opinion is that the design changes of these devices have had minimal impact on the rates of reoperation for lag screw cut-out, lag screw backout or periprosthetic fracture.
Conclusion
This is the first comprehensive meta-analysis exploring differences in aseptic reoperation rates relating to femoral nail lag screw configuration. Analysis of the current literature has identified there to be no difference, statistical or clinical in reoperation rates when utilising either single or dual separated screw devices. Due to the inherent limitations of the available data for dual integrated screw devices, decisive comparisons for clinical advantages and benefits of antirotation nails cannot be made.
ICMJE Conflict of Interest Statement
The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.
Funding Statement
This research was funded through an investigator-initiated grant by Smith & Nephew Inc Orthopaedic Division (SN). DT received fellowship funding from the NHMRC (CDF ID: 1126229).
References
- 1.↑
Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis International 2006 17 1726–1733. (https://doi.org/10.1007/s00198-006-0172-4)
- 2.↑
Gullberg B, Johnell O, Kanis JA. World-wide projections for hip fracture. Osteoporosis International 1997 7 407–413. (https://doi.org/10.1007/pl00004148)
- 3.↑
Forte ML, Virnig BA, Kane RL, Durham S, Bhandari M, Feldman R, Swiontkowski MF. Geographic variation in device use for intertrochanteric hip fractures. Journal of Bone and Joint Surgery: American Volume 2008 90 691–699. (https://doi.org/10.2106/JBJS.G.00414)
- 4.↑
Anglen JO, Weinstein JN & American Board of Orthopaedic Surgery Research Committee. Nail or plate fixation of intertrochanteric hip fractures: changing pattern of practice. A review of the American Board of Orthopaedic Surgery Database. Journal of Bone and Joint Surgery: American Volume 2008 90 700–707. (https://doi.org/10.2106/JBJS.G.00517)
- 5.↑
Knobe M, Gradl G, Ladenburger A, Tarkin IS, Pape HC. Unstable intertrochanteric femur fractures: is there a consensus on definition and treatment in Germany? Clinical Orthopaedics and Related Research 2013 471 2831–2840. (https://doi.org/10.1007/s11999-013-2834-9)
- 7.↑
Chapman T, Zmistowski B, Krieg J, Stake S, Jones CM, Levicoff E. Helical blade versus screw fixation in the treatment of hip fractures with cephalomedullary devices: incidence of failure and atypical ‘medial cutout’. Journal of Orthopaedic Trauma 2018 32 397–402. (https://doi.org/10.1097/BOT.0000000000001193)
- 8.↑
Li J, Zhang L, Zhang H, Yin P, Lei M, Wang G, Wang S, Tang P. Effect of reduction quality on post-operative outcomes in 31-A2 intertrochanteric fractures following intramedullary fixation: a retrospective study based on computerised tomography findings. International Orthopaedics 2019 43 1951–1959. (https://doi.org/10.1007/s00264-018-4098-1)
- 9.↑
Pinto FG, Dantas P, Moreira R, Mamede R, Amaral LB. Complications relating to accuracy of reduction of intertrochanteric fractures treated with a compressive hip screw. Hip International 2010 20 221–228. (https://doi.org/10.1177/112070001002000213)
- 10.↑
Socci AR, Casemyr NE, Leslie MP, Baumgaertner MR. Implant options for the treatment of intertrochanteric fractures of the hip: rationale, evidence, and recommendations. Bone and Joint Journal 2017 99 - B 128–133. (https://doi.org/10.1302/0301-620X.99B1.BJJ-2016-0134.R1)
- 11.↑
Hootman JM, Driban JB, Sitler MR, Harris KP, Cattano NM. Reliability and validity of three quality rating instruments for systematic reviews of observational studies. Research Synthesis Methods 2011 2 110–118. (https://doi.org/10.1002/jrsm.41)
- 12.↑
Simic M, Hinman RS, Wrigley TV, Bennell KL, Hunt MA. Gait modification strategies for altering medial knee joint load: a systematic review. Arthritis Care and Research 2011 63 405–426. (https://doi.org/10.1002/acr.20380)
- 13.↑
O'Connor SR, Tully MA, Ryan B, Bradley JM, Baxter GD, McDonough SM. Failure of a numerical quality assessment scale to identify potential risk of bias in a systematic review: a comparison study. BMC Research Notes 2015 8 224. (https://doi.org/10.1186/s13104-015-1181-1)
- 14.↑
Korakakis V, Whiteley R, Tzavara A, Malliaropoulos N. The effectiveness of extracorporeal shockwave therapy in common lower limb conditions: a systematic review including quantification of patient-rated pain reduction. British Journal of Sports Medicine 2018 52 387–407. (https://doi.org/10.1136/bjsports-2016-097347)
- 15.↑
Hooper P, Jutai JW, Strong G, Russell-Minda E. Age-related macular degeneration and low-vision rehabilitation: a systematic review. Canadian Journal of Ophthalmology 2008 43 180–187. (https://doi.org/10.3129/i08-001)
- 16.↑
DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials 1986 7 177–188. (https://doi.org/10.1016/0197-2456(8690046-2)
- 17.↑
Campbell I Chi-squared and Fisher-Irwin tests of two-by-two tables with small sample recommendations. Statistics in Medicine 2007 26 3661–3675. (https://doi.org/10.1002/sim.2832)
- 18.↑
Richardson JT The analysis of 2 × 2 contingency tables – yet again. Statistics in Medicine 2011 30 890; author reply 1–2. (https://doi.org/10.1002/sim.4116)
- 19.↑
Borenstein M, Hedges LV, Higgins JPT, Rothstein H. Fixed-Effect Versus Random-Effects Models: Introduction to Meta-analysis, pp. 61–75. Chichester, UK: John Wiley & Sons, 2009.
- 20.↑
Aktselis I, Kokoroghiannis C, Fragkomichalos E, Koundis G, Deligeorgis A, Daskalakis E, Vlamis J, Papaioannou N. Prospective randomised controlled trial of an intramedullary nail versus a sliding hip screw for intertrochanteric fractures of the femur. International Orthopaedics 2014 38 155–161. (https://doi.org/10.1007/s00264-013-2196-7)
- 21.↑
Babar IU, Qureshi AR, Afsar SS. An experience of the treatment of unstable inter-trochanteric fractures with the AO/ASIF proximal femoral nail. Journal of Postgraduate Medical Institute 2011 25 267–271.
- 22.↑
Bonnevialle P, Saragaglia D, Ehlinger M, Tonetti J, Maisse N, Adam P & Le Gall C French Hip and Knee Society (SFHG) & Trauma Surgery Academy (GETRAUM). Trochanteric locking nail versus arthroplasty in unstable intertrochanteric fracture in patients aged over 75 years. Orthopaedics and Traumatology, Surgery and Research 2011 97 (Supplement 6) S95–S100. (https://doi.org/10.1016/j.otsr.2011.06.009)
- 23.↑
Borger RA, Borger FA, Pires de Araujo R, Pereira TF, Queiroz RD. Prospective assessment of the clinical, radiographic and functional evolution of treatment for unstable trochanteric fractures of the femur using a cephalomedullary nail. Revista Brasileira de Ortopedia 2011 46 380–389. (https://doi.org/10.1016/S2255-4971(1530249-4)
- 24.↑
Bridle SH, Patel AD, Bircher M, Calvert PT. Fixation of intertrochanteric fractures of the femur – a randomized prospective comparison of the gamma-nail and the dynamic hip screw. Journal of Bone and Joint Surgery-British Volume 1991 73 330–334. (https://doi.org/10.1302/0301-620X.73B2.2005167)
- 25.↑
Buecking B, Bliemel C, Struewer J, Eschbach D, Ruchholtz S, Muller T. Use of the Gamma3 nail in a teaching hospital for trochanteric fractures: mechanical complications, functional outcomes, and quality of life. BMC Research Notes 2012 5 651. (https://doi.org/10.1186/1756-0500-5-651)
- 26.↑
Buecking B, Boese CK, Seifert V, Ruchholtz S, Frink M, Lechler P. Femoral offset following trochanteric femoral fractures: a prospective observational study. Injury 2015 46 (Supplement 4) S88–S92. (https://doi.org/10.1016/S0020-1383(1530024-3)
- 27.↑
Caiaffa V, Vicenti G, Mori C, Panella A, Conserva V, Corina G, Scialpi L, Abate A, Carrozzo M, Petrelli L, et al.Is distal locking with short intramedullary nails necessary in stable pertrochanteric fractures? A prospective, multicentre, randomised study. Injury 2016 47 (Supplement 4) S98–S106. (https://doi.org/10.1016/j.injury.2016.07.038)
- 28.↑
Catania P, Passaretti D, Montemurro G, Ripanti S, Carbone S, Candela V, Carnovale M, Gumina S, Pallotta F. Intramedullary nailing for pertrochanteric fractures of proximal femur: a consecutive series of 323 patients treated with two devices. Journal of Orthopaedic Surgery and Research 2019 14 449. (https://doi.org/10.1186/s13018-019-1506-1)
- 29.↑
Chinzei N, Hiranaka T, Niikura T, Tsuji M, Kuroda R, Doita M, Kurosaka M. Comparison of the sliding and femoral head rotation among three different femoral head fixation devices for trochanteric fractures. Clinics in Orthopedic Surgery 2015 7 291–297. (https://doi.org/10.4055/cios.2015.7.3.291)
- 30.↑
Ciaffa V, Vicenti G, Mori CM, Panella A, Conserva V, Corina G, Scialpi L, Speciale M, Fraccascia A, Picca G, et al.Unlocked versus dynamic and static distal locked femoral nails in stable and unstable intertrochanteric fractures. A prospective study. Injury 2018 49 (Supplement 3) S19–S25. (https://doi.org/10.1016/j.injury.2018.09.063)
- 31.↑
Dong Q, Zhang YG, Tian W. The effect of Pfna minimally invasive internal fixation on the postoperative slippage of fixing needle in elderly patients with femoral intertrochanteric fracture and the change of reset image. Acta Medica Mediterranea 2018 34 831–837. (https://doi.org/10.19193/0393-6384_2018_3_127)
- 32.↑
Efstathopoulos NE, Nikolaou VS, Lazarettos JT. Intramedullary fixation of intertrochanteric hip fractures: a comparison of two implant designs. International Orthopaedics 2007 31 71–76. (https://doi.org/10.1007/s00264-006-0128-5)
- 33.↑
Foulongne E, Gilleron M, Roussignol X, Lenoble E, Dujardin F. Mini-invasive nail versus DHS to fix pertrochanteric fractures: a case-control study. Orthopaedics and Traumatology, Surgery and Research 2009 95 592–598. (https://doi.org/10.1016/j.otsr.2009.08.007)
- 34.↑
Giessauf C, Glehr M, Bernhardt GA, Seibert FJ, Gruber K, Sadoghi P, Leithner A, Gruber G. Quality of life after pertrochanteric femoral fractures treated with a gamma nail: a single center study of 62 patients. BMC Musculoskeletal Disorders 2012 13 214. (https://doi.org/10.1186/1471-2474-13-214)
- 35.↑
Hardy DC, Descamps PY, Krallis P, Fabeck L, Smets P, Bertens CL, Delince PE. Use of an intramedullary hip-screw compared with a compression hip-screw with a plate for intertrochanteric femoral fractures. A prospective, randomized study of one hundred patients. Journal of Bone and Joint Surgery: American Volume 1998 80 618–630. (https://doi.org/10.2106/00004623-199805000-00002)
- 36.↑
Harrington P, Nihal A, Singhania AK, Howell FR. Intramedullary hip screw versus sliding hip screw for unstable intertrochanteric femoral fractures in the elderly. Injury 2002 33 23–28. (https://doi.org/10.1016/s0020-1383(0100106-1)
- 37.↑
Hopp S, Wirbel R, Ojodu I, Pizanis A, Pohlemann T, Fleischer J. Does the implant make the difference? – Prospective comparison of two different proximal femur nails. Acta Orthopaedica Belgica 2016 82 319–331.
- 38.↑
Ito J, Takakubo Y, Sasaki K, Sasaki J, Owashi K, Takagi M. Prevention of excessive postoperative sliding of the short femoral nail in femoral trochanteric fractures. Archives of Orthopaedic and Trauma Surgery 2015 135 651–657. (https://doi.org/10.1007/s00402-015-2200-3)
- 39.↑
Jolly A, Bansal R, More AR, Pagadala MB. Comparison of complications and functional results of unstable intertrochanteric fractures of femur treated with proximal femur nails and cemented hemiarthroplasty. Journal of Clinical Orthopaedics and Trauma 2019 10 296–301. (https://doi.org/10.1016/j.jcot.2017.09.015)
- 40.↑
Karakus O, Ozdemir G, Karaca S, Cetin M, Saygi B. The relationship between the type of unstable intertrochanteric femur fracture and mobility in the elderly. Journal of Orthopaedic Surgery and Research 2018 13 207. (https://doi.org/10.1186/s13018-018-0911-1)
- 41.↑
Kim JW, Kim TY, Ha YC, Lee YK, Koo KH. Outcome of intertrochanteric fractures treated by intramedullary nail with two integrated lag screws: a study in Asian population. Indian Journal of Orthopaedics 2015 49 436–441. (https://doi.org/10.4103/0019-5413.159647)
- 42.↑
Kouvidis G, Sakellariou VI, Mavrogenis AF, Stavrakakis J, Kampas D, Galanakis J, Papagelopoulos PJ, Katonis P. Dual lag screw cephalomedullary nail versus the classic sliding hip screw for the stabilization of intertrochanteric fractures. A prospective randomized study. Strategies in Trauma and Limb Reconstruction 2012 7 155–162. (https://doi.org/10.1007/s11751-012-0146-3)
- 43.↑
Lanzetti RM, Caraffa A, Lupariello D, Ceccarini P, Gambaracci G, Meccariello L, Manfreda F, Maiettini D, Vicente CI, Scialpi M, et al.Comparison between locked and unlocked intramedullary nails in intertrochanteric fractures. European Journal of Orthopaedic Surgery and Traumatology 2018 28 649–658. (https://doi.org/10.1007/s00590-018-2143-9)
- 44.↑
Lin J Encouraging results of treating femoral trochanteric fractures with specially designed double-screw nails. Journal of Trauma 2007 63 866–874. (https://doi.org/10.1097/TA.0b013e3180342087)
- 45.↑
Mavrogenis AF, Igoumenou VG, Megaloikonomos PD, Panagopoulos GN, Galanopoulos IP, Vottis CT, Karamanis E, Koulouvaris P, Papagelopoulos PJ. Dual head screw hip nailing for trochanteric fractures. SICOT-J 2017 3 61. (https://doi.org/10.1051/sicotj/2017049)
- 46.↑
Mavrogenis AF, Nikolaou V, Efstathopoulos N, Korres DS, Pneumaticos SG. Functional outcome and complications using the intramedullary hip screw for intertrochanteric fractures. Journal of Surgical Orthopaedic Advances 2011 20 188–192.
- 47.↑
Miedel R, Ponzer S, Tornkvist H, Soderqvist A, Tidermark J. The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomised, controlled trial. Journal of Bone and Joint Surgery: British Volume 2005 87 68–75.
- 48.↑
Papasimos S, Koutsojannis CM, Panagopoulos A, Megas P, Lambiris E. A randomised comparison of AMBI, TGN and PFN for treatment of unstable trochanteric fractures. Archives of Orthopaedic and Trauma Surgery 2005 125 462–468. (https://doi.org/10.1007/s00402-005-0021-5)
- 49.↑
Park SR, Kang JS, Kim HS, Lee WH, Kim YH. Treatment of intertrochanteric fracture with the Gamma AP locking nail or by a compression hip screw – a randomised prospective trial. International Orthopaedics 1998 22 157–160. (https://doi.org/10.1007/s002640050231)
- 50.↑
Schipper IB, Steyerberg EW, Castelein RM, van der Heijden FH, den Hoed PT, Kerver AJ, van Vugt AB. Treatment of unstable trochanteric fractures. Randomised comparison of the gamma nail and the proximal femoral nail. Journal of Bone and Joint Surgery: British Volume 2004 86 86–94. (https://doi.org/10.1302/0301-620X.86B1.14455)
- 51.↑
Shin YS, Chae JE, Kang TW, Han SB. Prospective randomized study comparing two cephalomedullary nails for elderly intertrochanteric fractures: Zimmer natural nail versus proximal femoral nail antirotation II. Injury 2017 48 1550–1557. (https://doi.org/10.1016/j.injury.2017.04.011)
- 52.↑
Su H, Sun K, Wang X. A randomized prospective comparison of Intertan and Gamma3 for treating unstable intertrochanteric fractures. International Journal of Clinical and Experimental Medicine 2016 9 8640–8647.
- 53.↑
Vaquero J, Munoz J, Prat S, Ramirez C, Aguado HJ, Moreno E, et al.Proximal femoral nail antirotation versus Gamma3 nail for intramedullary nailing of unstable trochanteric fractures. A randomised comparative study. Injury 2012 43 (Supplement 2) S47–S54. (https://doi.org/10.1016/S0020-1383(1370179-7)
- 54.↑
Varela-Egocheaga JR, Iglesias-Colao R, Suarez-Suarez MA, Fernandez-Villan M, Gonzalez-Sastre V, Murcia-Mazon A. Minimally invasive osteosynthesis in stable trochanteric fractures: a comparative study between Gotfried percutaneous compression plate and gamma 3 intramedullary nail. Archives of Orthopaedic and Trauma Surgery 2009 129 1401–1407. (https://doi.org/10.1007/s00402-009-0955-0)
- 55.↑
Vidyadhara S, Rao SK. One and two femoral neck screws with intramedullary nails for unstable trochanteric fractures of femur in the elderly – randomised clinical trial. Injury 2007 38 806–814. (https://doi.org/10.1016/j.injury.2006.08.050)
- 56.↑
Wu D, Ren G, Peng C, Zheng X, Mao F, Zhang Y. InterTan nail versus Gamma3 nail for intramedullary nailing of unstable trochanteric fractures. Diagnostic Pathology 2014 9 191. (https://doi.org/10.1186/s13000-014-0191-y)
- 57.↑
Wu K, Xu Y, Zhang L, Zhang Y, Xu W, Chu J, Bao N, Ma Q, Yang H, Guo JJ. Which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients. Journal of Orthopaedic Translation 2020 21 18–23. (https://doi.org/10.1016/j.jot.2019.11.003)
- 58.↑
Xu Y, Geng D, Yang H, Wang X, Zhu G. Treatment of unstable proximal femoral fractures: comparison of the proximal femoral nail antirotation and gamma nail 3. Orthopedics 2010 33 473. (https://doi.org/10.3928/01477447-20100526-03)
- 59.↑
Yang YH, Wang YR, Jiang SD, Jiang LS. Proximal femoral nail antirotation and third-generation Gamma nail: which is a better device for the treatment of intertrochanteric fractures? Singapore Medical Journal 2013 54 446–450. (https://doi.org/10.11622/smedj.2013152)
- 60.↑
Yao C, Zhang CQ, Jin DX, Chen YF. Early results of reverse less invasive stabilization system plating in treating elderly intertrochanteric fractures: a prospective study compared to proximal femoral nail. Chinese Medical Journal 2011 124 2150–2157. (https://doi.org/10.3760/cma.j.issn.0366-6999.2011.14.013)
- 61.↑
Yaozeng X, Dechun G, Huilin Y, Guangming Z, Xianbin W. Comparative study of trochanteric fracture treated with the proximal femoral nail anti-rotation and the third generation of gamma nail. Injury 2010 41 1234–1238. (https://doi.org/10.1016/j.injury.2010.03.005)
- 62.↑
Werner BC, Fashandi AH, Gwathmey FW, Yarboro SR. Trends in the management of intertrochanteric femur fractures in the United States 2005–2011. Hip International 2015 25 270–276. (https://doi.org/10.5301/hipint.5000216)
- 63.↑
Lee YK, Yoon BH, Nho JH, Kim KC, Ha YC, Koo KH. National trends of surgical treatment for intertrochanteric fractures in Korea. Journal of Korean Medical Science 2013 28 1407–1408. (https://doi.org/10.3346/jkms.2013.28.9.1407)
- 64.↑
Tsai SW, Lin C-FJ, Tzeng YH, Lin CC, Huang CK, Chang MC, Chiang CC. Risk factors for cut-out failure of Gamma3 nails in treating unstable intertrochanteric fractures: an analysis of 176 patients. Journal of the Chinese Medical Association 2017 80 587–594. (https://doi.org/10.1016/j.jcma.2017.04.007)
- 65.↑
Norris R, Bhattacharjee D, Parker MJ. Occurrence of secondary fracture around intramedullary nails used for trochanteric hip fractures: a systematic review of 13,568 patients. Injury 2012 43 706–711. (https://doi.org/10.1016/j.injury.2011.10.027)
- 66.↑
Stern LC, Gorczyca JT, Kates S, Ketz J, Soles G, Humphrey CA. Radiographic review of helical blade versus lag screw fixation for cephalomedullary nailing of low-energy peritrochanteric femur fractures: there is a difference in cutout. Journal of Orthopaedic Trauma 2017 31 305–310. (https://doi.org/10.1097/BOT.0000000000000853)
- 67.↑
Nherera L, Trueman P, Horner A, Johnstone A, Watson J. A meta-analysis of integrated compression screw compared to single screw nails using a single lag screw or single helical blade screw for intertrochanteric hip fractures. Rheumatology and Orthopedic Medicine 2018 3 1–10. (https://doi.org/10.15761/ROM.1000156)
- 68.↑
Pollet TV, Stulp G, Henzi SP, Barrett L. Taking the aggravation out of data aggregation: a conceptual guide to dealing with statistical issues related to the pooling of individual-level observational data. American Journal of Primatology 2015 77 727–740. (https://doi.org/10.1002/ajp.22405)
- 69.↑
Caruso G, Bonomo M, Valpiani G, Salvatori G, Gildone A, Lorusso V, Massari L. A six-year retrospective analysis of cut-out risk predictors in cephalomedullary nailing for pertrochanteric fractures: can the tip-apex distance (TAD) still be considered the best parameter? Bone and Joint Research 2017 6 481–488. (https://doi.org/10.1302/2046-3758.68.BJR-2016-0299.R1)
- 70.↑
Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. Journal of Bone and Joint Surgery: American Volume 1995 77 1058–1064. (https://doi.org/10.2106/00004623-199507000-00012)
- 71.↑
Geller JA, Saifi C, Morrison TA, Macaulay W. Tip-apex distance of intramedullary devices as a predictor of cut-out failure in the treatment of peritrochanteric elderly hip fractures. International Orthopaedics 2010 34 719–722. (https://doi.org/10.1007/s00264-009-0837-7)
