Abstract
Purpose
This systematic review and meta-analysis aimed to compare the outcomes of open- versus closed-reduction and intramedullary nailing (IMN) of adult femur shaft fractures.
Methods
Four databases were searched from inception until July 2022 for original studies that compared the outcomes of IMN following open-reduction versus closed-reduction technique. The primary outcome was the union rate; the secondary outcomes were time to union, nonunion, malalignment, revision, and infection. This review was conducted in line with PRISMA guidelines.
Results
A total of 12 studies with 1299 (1346 IMN cases) patients were included, with a mean age of 32.3 ± 3.25. The average follow-up was 2.3 ± 1.45 years. There was a statistically significant difference in union rate (OR, 0.66; 95% CI, 0.45–0.97; p-value, 0.0352), nonunion (OR, 2.06; 95% CI, 1.23–3.44; p-value, 0.0056), and infection rate (OR, 1.94; 95% CI, 1.16–3.25; p-value, 0.0114) between the open-reduction and closed-reduction groups in favour of the latter. However, malalignment was significantly higher in the closed-reduction group (OR, 0.32; 95% CI, 0.16–0.64; p-value, 0.0012), whereas time to union and revision rates were similar (p = NS).
Conclusion
This study showed that closed-reduction and IMN had more favourable union rate, nonunion, and infection rates than the open-reduction group, yet malalignment was significantly less in the open-reduction group. Moreover, time to union and revision rates were comparable. However, these results must be interpreted in context due to confounding effects and the lack of high-quality studies.
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Introduction
Femur shaft fractures are among the most common fractures encountered in orthopaedic trauma practice, with an overall incidence of 10–21/100,00 persons per year [1, 2]. Of those, 40% occurred due to road traffic accidents and other high-energy trauma mechanisms [1, 2].
Due to the principal load-bearing role of the femur, femur shaft fractures are often associated with prolonged morbidity and extensive disability if improperly treated [3]. As a result, tremendous advances in treating femoral shaft fractures have been seen, with the gold standard for treatment remaining intramedullary nailing (IMN). While the standard routine insertion of IMN is done following closed fracture reduction, this is not always feasible due to fracture complexity, equipment’s availability, surgeon’s experience, and patient-related factors (obesity and polytrauma); thus, an open-reduction technique might be needed to achieve proper reduction alignment in some challenging cases [4].
In addition, several studies have shown that the open-reduction technique is associated with a higher risk of infection and lower union rates [5,6,7]. However, some of the setbacks were low power with small sample sizes and short-term follow-up. Therefore, high-quality evidence is needed to compare outcomes properly across both groups.
The purpose of this study was to compare the clinical and radiological outcomes of open- versus closed-reduction and IMN of such fractures. We hypothesize that there is no significant difference in outcomes and complication rates between patients treated with open-reduction and IMN versus those treated with closed-reduction and IMN.
Materials and methods
This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [8]. A protocol registration was sought in advance on the International Prospective Register of Systematic Reviews (PROSPERO) with the registration number: CRD42023327089.
Search strategy: outcomes of interest
PubMed/Medline, Web of Science, Google Scholar, and Cochrane library databases were searched from inception until July 2022 with the following keywords and their derivatives: Open AND closed AND reduction AND intramedullary nail AND femur shaft AND fractures. Two authors independently screened the search results based on the title and/or abstract. If any discrepancy arose, it was resolved by a discussion with a third senior author.
The union rate was the primary outcome and was defined as the radiological bridging callus formation across three out of four cortices with a painless fracture site. Time to union, non-union, malalignment, infection, and revision rates were all used as secondary outcomes of interest.
Eligibility criteria
Inclusion criteria:
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1.
RCTs and observational studies comparing open versus closed reductions and intramedullary nailing of femoral shaft fractures
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2.
Studies with a minimum follow-up period of six months
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3.
Skeletally mature patients > 16 years
Exclusion criteria:
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1.
Studies reporting open and pathological fractures
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2.
Studies with proximal or distal femur (non-diaphyseal) fractures
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3.
Review articles, cross-sectional, case series, reports, and noncomparative studies
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4.
Studies missing essential data needed for analysis
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5.
Studies conducted on animals
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6.
Studies published in languages other than English
Data extraction and items
Two independent authors used a pre-designed data collection sheet to extract data. The extracted demographic data included the first authors’ surnames, study year, design and country, the mean age of patients, number of participants, number of IMN cases (open vs closed), mean follow-up period, union rate, non-union, malalignment, time to union, operative time, infection and revision rate, statistical tests, and conclusion.
Qualitative assessment (risk of bias)
Two authors assessed the methodological quality of the included studies using the Newcastle–Ottawa tool, which comprises three main elements: patient selection, comparability, and outcomes [9, 10]. A higher overall score indicates a lower risk of bias; a score of 5 or less (out of 9) corresponds to a high risk of bias. Rob-2 [11] tool was used to evaluate the included RCT.
Quantitative analysis (meta-analysis)
A meta-analysis of eligible studies using R (version 4.0.2, R Core Team, Vienna, Austria, 2020) using the meta package (i.e., forest_meta, metacont, metabin, and metabias functions) was performed. Odds ratios (OR) and their associated 95% confidence intervals were expressed for dichotomous variables (e.g., rate of union). For continuous variables, standardized mean differences (SMD) and their associated standardized errors and deviation values were calculated for all eligible studies. In studies that have only provided median values (± range) or isolated mean values, their standard deviation was imputed per the guidelines of Cochrane (refer to Chapter 7.7.3.3) and the methods delineated by Shi et al. (2020), Walter et al. (2007), Luo et al. (2018), and Wan et al. (2014). Heterogeneity among effect sizes was evaluated using the I-squared statistic. Definitions for heterogeneity were adapted from the Cochrane handbook (> 25% mild, 25–50% moderate, > 50% severe). Both a funnel plot and Egger’s test of asymmetry were utilized to assess publication bias. Due to the low heterogeneity for the dichotomous variables, a common-effects model was utilized for the included studies; otherwise, a random-effects model was deployed.
Results
Search results
Rayyan AI website was used to manage the literature search results [12]. Searching the databases yielded 197 articles, and after removing 23 duplicates, 174 records were screened by title and abstracts, of which 151 were excluded. A total of 23 papers were eligible for a full-text review. As a result, 12 studies met the eligibility criteria and were included in the qualitative and quantitative syntheses. The PRISMA flowchart is displayed in Fig. 1.
Studies characteristics
Twelve studies (1331 femur shaft fractures) were included in this meta-analysis, with a mean patient age of 32.3 ± 3.25. The mean follow-up was 2.3 ± 1.45 years. One randomized clinical trial was included, six studies were prospective cohorts, and five were retrospective. Ten studies were used to analyse union rates, eight studies for time to union, malalignment, and revision, and nine studies reported on non-union and infection rates. The characteristics of the included studies are summarized in Table 1.
Quality assessment (level of evidence (LoE) and risk of bias)
Based on the OCEBM criteria [24], one study was level 2a, six studies were level 2b, and five were level 3a (Table 1), with an overall grade B of recommendation assigned to the review [25]. The Newcastle–Ottawa scores of all 11 observational studies ranged from 4 to 7, with an average of 6 ± 1, indicating an acceptable overall risk of bias (Table 2). However, using Rob-2 assessment tool, the RCT by Chaudry et al. had a high overall risk (Table 3). While five (41%) of the included studies reported high bias risk, the remaining nine (59%) were of fair quality. A summary of the qualitative assessment, according to the Newcastle–Ottawa scale, is shown in Table 2.
Union rate
A total of ten articles investigated rate of union among patients undergoing open- and closed-type reductions. Our analysis demonstrated that patients undergoing open-reduction surgeries are associated with a lower probability of union than their closed counterparts (OR, 0.66; 95% CI, 0.45–0.97; p-value, 0.0352) (refer to Fig. 2).
Time to union
Eight articles provided relevant data on the time taken for completion of union. Heterogeneity among articles was high (I2, 89.7%; p-value, < 0.001); thus, a random-effects model was utilized. Differences in time to union were insignificant among participants undergoing open- and closed-reductions (SMD, 0.41; 95% CI, − 0.11 to 1.21; p-value, 0.0906) (refer to Fig. 3).
Non-union rate
In terms of direct non-union rates, a total of nine studies reporting on incidence of non-union across open- and closed-reduction surgeries. Participants undergoing open-reduction were associated with less favourable outcomes compared to closed-reduction in terms of non-union rates (OR, 2.06; 95% CI, 1.23–3.44; p-value, 0.0056) (refer to Fig. 4).
Malalignment rate
Participants undergoing open-reduction surgeries were associated with a lower probability of experiencing post-operative malalignments (OR, 0.32; 95% CI, 0.16–0.64; p-value, 0.0012) (refer to Fig. 5). Heterogeneity among the eight articles reporting on malalignment was low (I2, 0.0%; p-value, 0.8351).
Infection rate
Probability of post-operative infections among patients undergoing open reduction was significantly higher than that of their closed-reduction counterparts (OR, 1.94; 95% CI, 1.16–3.25; p-value, 0.0114) (refer to Fig. 6).
Rate of revisions
In contrast, patients undergoing closed-reduction surgeries were associated with a higher probability with revisions (OR, 0.85; 95% CI, 0.53–1.35; p-value, 0.4987) (refer to Fig. 7). While the difference in revision rate was insignificant, heterogeneity was low among the 8 studies (I2, 0.0%; p-value, 0.4497).
Publication bias
Egger’s test of bias demonstrated insignificant publication bias for dichotomous variables (p-value, 0.6913) (refer to Supplementary Funnel figures 1 through 5).
Discussion
The main findings of this systematic review and meta-analysis were that union rate, nonunion rate, and infection rate were more favourable in the closed-reduction group, whereas the malalignment was more favourable in the open-reduction group. However, time to union and revision rates were comparable. A meta-analysis summary of the 6 main variable outcomes comparing open- versus closed-reduction methods is shown in Table 4.
The intramedullary nail is considered the treatment of choice for nearly all femur shaft fractures. Ideally, fracture reduction is achieved by closed-reduction means; however, open reduction might be inevitable in certain situations where we have soft tissue interposition, severely comminuted fracture, and associated injuries, and in obese or muscular patients. Many studies have compared the outcome of closed versus open reduction in femur shaft fracture, with some authors claiming that the outcome is comparable between each group.
Contrary to several studies which showed no significant difference in union rate [16, 17, 19, 20], our analysis demonstrated that patients with femur shaft fractures treated with open reductions IMN had a significantly lower union rate when compared to those treated with closed reduction (OR, 0.66; 95% CI, 0.45–0.97). The violation and disruption of the fracture haematoma and its positive role in bone healing might explain this significant finding [26]. Similarly, a significantly higher non-union rate was observed in the open-reduction group (OR, 2.06; 95% CI, 1.23–3.44). Non-union was consistently defined across the included studies as the radiographic persistence of a radiolucent line without progression of callus formation, along with pain at the fracture site at a minimum of six months after the surgery. This universal agreement on defining non-union enabled us to pool these studies and compare this outcome with very low heterogeneity (I2 = 0%) and statistical significance. Telgheder et al. [21] retrospectively studied 107 patients with traumatic femur shaft fracture who underwent intramedullary nail preceded by either closed or open reduction; they reported a comparable mean time to union in closed reduction and open reduction and combined groups of 5.4 months, 6.2 months, and 5.6 months, respectively (p = NS). This present study supports this finding as there was no difference in time to union among both groups (SMD, 0.41; 95% CI, − 0.11 to 1.21, p = NS).
Karaman et al. [27] reported a 41.7% incidence of rotational malalignment of more than 10° following closed reduction and intramedullary nailing of femur shaft fracture on CT; these patients were symptomatic and had significantly lower functional scores compared to those without malalignment. Open-reduction techniques can aid in the precise and anatomical restoration of fracture fragments. Similarly, our meta-analysis showed that open reduction reduces the risk of malalignment to less than one-third compared to the closed-reduction group (OR, 0.32; 95% CI, 0.16–0.64, p < 0.05).
Infection rates following intramedullary nails of femoral shaft fractures are generally low, ranging from 1 to 3.8% [28]. Out of 118 enrolled patients, Nandhimandalam et al. [23] reported 4 cases of superficial infection, 2 in each arm and only one with deep infection in the open group, results which were statistically insignificant. These findings were also replicated by subsequent studies [20, 21]. Haq et al. [22] compared the infection rate in closed and open groups and reported a significantly higher risk with open reduction (6.4% vs 24%). However, pooling various studies demonstrated a twice higher risk of infection in patients with open reduction than those who underwent closed reduction (OR, 1.94; 95% CI, 1.16–3.25, p < 0.05). The increased surgical time, peri-operative antibiotics use, and direct manipulation of soft tissue through open reduction can contribute to this increased infection risk. However, these confounding factors were not clearly mentioned in the included studies. Thus, a future prospective study matching these confounders is warranted.
Although the revision rate difference was insignificant between the two groups, with a higher probability of revision in the closed-reduction group (OR, 0.85; 95% CI, 0.53–1.35), it is worth mentioning that the revision is done for all causes necessitating surgery, including but not limited to deep infection, nonunion, and malalignment [13, 21, 29].
To the best of our knowledge, this systematic review was the first to analyze and compare open- versus closed-reduction techniques in IMN treatment of femur shaft fractures. However, several limitations must be acknowledged. First, some of the included studies were of low quality, reducing the confidence in the results, including an RCT with a questionable randomization method and an apparent selection bias. Regardless, these studies remain the highest level of available evidence in the literature. Another weakness was the inadequate reporting of some confounding factors, such as the type of IMN used and baseline comorbidities which were not clearly stated in all studies. Also, several comparison outcomes, like operative time and radiation exposure, were either missed or poorly reported. Thus, future prospective studies are needed to adjust for these confounders.
Conclusion
Closed-reduction IMN was associated with more favourable union rate, nonunion rate, and infection rate compared to the open-reduction group, whereas malalignment was significantly less in the open-reduction group. However, time to union and revision rates were comparable. This finding should be applied in context due to potential confounding factors and the lack of high-quality studies.
Data availability
Not applicable as this is a review article. However, happy to provide access to any statistical data (coding) upon request.
References
Weiss RJ, Montgomery SM, Al Dabbagh Z, Jansson KA (2009) National data of 6409 Swedish inpatients with femoral shaft fractures: stable incidence between 1998 and 2004. Injury 40(3):304–308. https://doi.org/10.1016/j.injury.2008.07.017
Enninghorst N, McDougall D, Evans JA, Sisak K, Balogh ZJ (2013) Population-based epidemiology of femur shaft fractures. J Trauma Acute Care Surg 74(6):1516–1520. https://doi.org/10.1097/TA.0b013e31828c3dc9
Whittle AP, Wood GW. Fractures of the lower extremity (2003) In: Canale ST, Beaty JH, eds. Campbell's operative orthopaedics. 10th ed. Philadelphia, PA: Mosby
Kimmatkar N, Hemnani JT, Hemnani TJ, Jain SK (2014) Diaphyseal femoral intramedullary nailing: closed or open intervention? Int J Sci Study 1(5):15–18
Scannell BP, Waldrop NE, Sasser HC, Sing RF, Bosse MJ (2010) Skeletal traction versus external fixation in the initial temporization of femoral shaft fractures in severely injured patients. J Trauma 68(3):633–640. https://doi.org/10.1097/TA.0b013e3181cef471
Rozbruch SR, Müller U, Gautier E, Ganz R (1998) The evolution of femoral shaft plating technique. Clin Orthop Relat Res 354:195–208. https://doi.org/10.1097/00003086-199809000-00024
Geissler WB, Powell TE, Blickenstaff KR, Savoie FH (1995) Compression plating of acute femoral shaft fractures. Orthopedics 18(7):655–660. https://doi.org/10.3928/0147-7447-19950701-13
Moher D, Liberati A, Tetzlaff J, Altman DG (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 62:1006–1012
Lo CKL, Mertz D, Loeb M (2014) Newcastle-Ottawa Scale: comparing reviewers’ to authors’ assessments. BMC Med Res Methodol 14(1):1–5
Stang A (2010) Critical evaluation of the newcastle-ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol 25(9):603–605. https://doi.org/10.1007/s10654-010-9491-z
Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Higgins JPT (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 366:l4898. https://doi.org/10.1136/bmj.l4898
Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A (2016) Rayyan—a web and mobile app for systematic reviews. Syst Rev 5:210
Leighton RK, Waddell JP, Kellam JF, Orrell KG (1986) Open versus closed intramedullary nailing of femoral shaft fractures. J Trauma 26(10):923–926
Gharahdaghi M, Rahimi H, Bahari M, Afzali J (2007) A prospective study of closed and open reamed intramedullary nailing of 136 femoral shaft fractures in adults. J Res Med Sci 12(1):1–6
Tahririan MA, Andalib A (2014) Is there a place for open intramedullary nailing in femoral shaft fractures? Adv Biomed Res 3:157. https://doi.org/10.4103/2277-9175.137870
Seetharamaiah VB, Basavarajanna S, Mahendra AR, Vivekanandaswamy AN (2015) Comparison of closed and open interlocking nailing techniques in femoral shaft fractures. J Evid Based Med Healthc 2(49):8514–8518. https://doi.org/10.18410/jebmh/2015/1167
Chaudhary P, Maharjan R, Kalawar RPS, Baral P, Shah AB (2017) Randomized controlled trial comparing open versus closed interlocking nail for closed fracture shaft of femur in adults. Int J Orthop Sci 3(1):591–595
Kumar SK, Kumar KV (2018) Comparative study of surgical management of fracture shaft of femur with intramedullary interlocking nail: open VS closed type. Natl J Clin Orthop 2(1):22–25
Kisan D, Samant S (2018) A comparison of closed intramedullary nailing with open intramedullary nailing in femoral shaft fractures of adults. Int J Orthop Sci 4(2):88–90
Ghouri SI, Alhammoud A, Alkhayarin MM (2020) Does open reduction in intramedullary nailing of femur shaft fractures adversely affect the outcome? A retrospective study. Adv Orthop 2020.
Telgheder ZL, Albanese MA, Bloom DS, Kurra S, Sullivan MP (2020) A comparison of complications and union rates in intramedullary nailing of femoral shaft fractures treated with open versus closed reduction. Orthopedics 43(2):103–107
Naeem-Ul-Haq S, Abidi SAR, Jalil SA, Ahmed SA, Tunio ZH, Umer MF, Khan TJ (2020) Comparison of closed versus open interlocking nail femur: a retrospective cohort study in a tertiary care hospital. J Pak Orthop Assoc 32(03):125–130
Nandhimandalam B, Das S, Zalariya S, Azam MQ, Mittal A (2021) Is mini-open intramedullary nailing an effective intervention for adult femoral diaphyseal fractures in odd hours? A prospective case-control functional outcome and radiation safety study. Injury 52(4):971–976
OCEBM Levels of Evidence Working Group (2011) The Oxford Levels of Evidence 2. https://www.cebm.net/index.aspx?o=5653. Accessed 10 Dec 2022
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso- Coello P et al (2008) GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336(7650):924–926
Schell H, Duda GN, Peters A, Tsitsilonis S, Johnson KA, Schmidt-Bleek K (2017) The haematoma and its role in bone healing. J Exp Orthop 4(1):1–11
Karaman O, Ayhan E, Kesmezacar H, Seker A, Unlu MC, Aydingoz O (2014) Rotational malalignment after closed intramedullary nailing of femoral shaft fractures and its influence on daily life. Eur J Orthop Surg Traumatol 24(7):1243–1247
Ricci WM, Gallagher B, Haidukewych GJ (2009) Intramedullary nailing of femoral shaft fractures: current concepts. J Am Acad Orthop Surg 17(5):296–305
Lindsey JD, Krieg JC (2011) Femoral malrotation following intramedullary nail fixation. J Am Acad Orthop Surg 19(1):17–26
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All the authors contributed to the study conception and design. Material preparation, literature review, data collection, and quality assessment were performed by LAS, MFR, OMB, AFA, and AAA. Statistical analysis was performed by AA. The first draft of the manuscript was written by LAS and AA; MFR and all the authors commented on previous versions of the manuscript. All the authors read and approved the final manuscript.
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Salman, L.A., Al-Ani, A., Radi, M.F.A. et al. Open versus closed intramedullary nailing of femur shaft fractures in adults: a systematic review and meta-analysis. International Orthopaedics (SICOT) 47, 3031–3041 (2023). https://doi.org/10.1007/s00264-023-05740-x
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DOI: https://doi.org/10.1007/s00264-023-05740-x