Abstract
This meta-analysis compared outcomes between percutaneous pinning/wiring and open reduction internal fixation (ORIF) with locking plates for treatment of unstable distal radius fractures. Medline, Cochrane, EMBASE, and Google Scholar were searched through December 30, 2015. Twenty randomised controlled trials (RCTs) and non-randomised two-arm studies were included. Outcomes included scores of Disabilities of the Arms, Shoulders and Hands (DASH), visual analogue scale (VAS) pain, and patient rated wrist evaluation (PRWE) score, as well as range of motion (ROM) and complication incidence. ORIF/plating was associated with lower DASH scores but longer procedure time, while there was no difference between the two methods with respect to VAS pain score and PRWE score. The overall incidence of complications, including complex regional pain syndrome, was higher with pinning/wiring, though the incidence of carpal tunnel syndrome and nerve defects was not different. Supination and grip strength were better with ORIF. Radiographically, ulnar variation was greater with pinning/wiring. These results suggest that ORIF/plating is the preferred method of managing unstable distal radius fractures.
Level of evidence: II
Introduction
Fractures of the distal radius represent one of the most common fractures seen by orthopaedic surgeons (Chung et al., 2006; Ruch and McQueen, 2010; Singer et al., 1998). These fractures are most common in postmenopausal women, resulting from osteoporosis, with a lifetime risk of sustaining a distal radius fracture of 15% for women and 2% for men (van Staa et al., 2001; Ruch and McQueen, 2010). Fractures are primarily the result of high energy trauma in young adults and from a simple fall in the elderly (Ruch and McQueen, 2010). Despite their frequent occurrence, the best choice for treating unstable distal radial fractures is controversial.
While distal radius fractures may be treated with casting if the bones are aligned, displacement may require some form of reduction and fixation to achieve an adequate outcome (Ruch and McQueen, 2010). The two most common methods of fixation are external fixation using pins and/or Kirschner wires (K-wire), and open reduction internal fixation (ORIF) with a volar locking plate (Ruch and McQueen, 2010). K-wire fixation is mostly successful, but percutaneous K-wires are not load bearing, do not protect against radial shortening, and have been associated with loss of reduction, stiffness of the fingers, sensory nerve disturbances, and pin track infection (Kreder et al., 2005). ORIF with a locking plate offers advantages over K-wire fixation including greater stability, earlier mobilisation of the hand, and return to normal activities; however, it is a more invasive procedure with associated greater risk (Karantana et al., 2013; Phadnis et al., 2012; Tubeuf et al., 2015). Although various studies have compared the two methods and examined various outcomes (Costa et al., 2014; Goehre et al., 2014; Hollevoet et al., 2011; Jubel et al., 2005; Karantana et al., 2013; Maire et al., 2013; Marcheix et al., 2010; McFadyen et al., 2011; Oshige et al., 2007; Rozental et al., 2009; Saddiki et al., 2012; Zhao et al., 2012), it remains unclear which is the better treatment . Prior meta-analyses have not definitively shown that one procedure has clear advantages over the other (Meier et al., 2012; Wei et al., 2012; Zong et al., 2015).
Thus, the purpose of this study was to perform a meta-analysis to compare functional and radiographic outcomes and complications between percutaneous pinning/wiring and ORIF using a locking plate for treating unstable distal radius fractures.
Methods
Literature search strategy, study selection, and data extraction
This systematic review and meta-analysis was conducted in accordance with PRISMA guidelines (Liberati et al., 2009). Medline, Cochrane, EMBASE, and Google Scholar databases were searched up to December 30, 2015 using combinations of the following keywords: percutaneous pin, pinning, K-wire, Kirschner, locking plate, plate osteosynthesis, radius, forearm fracture. Reference lists of relevant studies were manually searched to identify potential articles of interest. There was no language restriction in the database searches. Searches were conducted by two independent reviewers, YL and ZW, and a third reviewer, FP, was consulted for resolutions of any disagreements. All reviewers were orthopaedic hand surgeons.
We included randomised controlled trials (RCTs), non-randomised two-arm studies, and retrospective studies comparing percutaneous pinning/wiring versus ORIF with volar locking plates for unstable distal radius fractures. Inclusion also required that the studies reported data of at least one outcome of interest (as described below). No length of follow-up time was specified. One-arm studies, letters, comments, editorials, case reports, and proceedings were excluded.
The following information was extracted from studies that met the inclusion criteria: the name of the first author, year of publication, study design and patient selection criteria, number of patients in each treatment group, patient age and sex, fracture type, surgeon experience, intervention, outcomes, and follow-up time. Data were extracted by two reviewers, and disagreements were resolved by consultation with a third reviewer.
Quality assessment
The methodological quality of randomised studies was assessed with two reviewers using the risk-of-bias assessment tool outlined in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0) (Higgins, 2011). Briefly, six domains were evaluated: random sequence generation, allocation concealment, blinding of patients and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting risk. Non-randomised studies were assessed by two independent reviewers using the Newcastle-Ottawa scale (NOS), which is a validated tool for evaluating non-randomised studies for three criteria: patient selection, comparability of study groups, and outcome assessment.
Outcome measures and data analysis
Outcome measures examined in the meta-analysis were Disabilities of the Arms, Shoulders and Hands (DASH) score, visual analogue scale (VAS) pain score, patient rated wrist evaluation (PRWE) score, procedure time, range of motion (ROM), grip strength, radiographic assessment parameters (radial length, ulnar variance, volar tilt, radial inclination) and total complication incidence. Complications included nonunion, wound infection (superficial or deep), nerve injuries, carpal tunnel syndrome, complex regional pain syndrome, tendon complications (rupture or inflammation), loss of reduction, and reoperation.
Outcomes were compared between the two groups. Odds ratios (ORs) were calculated for dichotomous outcomes, and standard difference in means (SDM) were calculated for continuous outcomes along with 95% confidence intervals (CIs) in the pinning/wiring group compared with the ORIF/plating group. A χ2-based test of homogeneity was performed, and the inconsistency index (I2) and Cochran Q statistics were determined. If the I2 statistic was > 50% or the Cochran Q value of p was < 0.01, significant heterogeneity was considered to be present and a random-effects model of analysis was used. Otherwise, a fixed-effects model was employed.
Some argue that since clinical and methodological diversity always occur in a meta-analysis, statistical heterogeneity is inevitable (Higgins et al., 2003). Thus, testing for heterogeneity is irrelevant to the choice of analysis because heterogeneity will always exist, whether or not it can be detected using a statistical test. To this end, methods have been developed for quantifying inconsistency across studies that move the focus away from testing whether heterogeneity is present to assessing its impact on the meta-analysis. A useful statistic for quantifying inconsistency is: I2 = (Q-df/Q) × 100%, where Q is the chi-square statistic and df is its degrees of freedom (Higgins and Thompson, 2002; Higgins et al., 2003). This describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance). However, thresholds for the interpretation of I2 can be misleading since the importance of inconsistency depends on several factors. A rough guide to interpretation is as follows: 0% to 40%: might not be important; 30% to 60%: may represent moderate heterogeneity; 50% to 90%: may represent substantial heterogeneity; 75% to 100%: considerable heterogeneity. Thus, most studies use a cutoff of 50% to determine which method of analysis is used (i.e., random-effects or fixed-effects).
Pooled effects were calculated, and a two-sided p value < 0.05 was considered to indicate statistical significance. Subgroup analysis was also performed by study design (RCTs versus non-randomised studies). Since RCTs and non-randomised trials represent different levels in evidence-based medicine, we used subgroup analysis to address the clinical heterogeneity between these two types of studies.
Sensitivity analysis was carried out using the leave-one-out approach. A sensitivity analysis is used to clarify whether the findings are consistent and robust; consistent results provide stronger evidence of an effect (Higgins, 2011). Publication bias analysis was not performed if there were < 10 studies, as ≥ 10 studies are needed to detect funnel plot asymmetry (Sterne et al., 2011). The absence of publication bias was indicated by the data points forming a symmetric funnel-shaped distribution and one-tailed significance level p > 0.05 by Egger’s test. Publication bias occurs when the publication of studies depends on the nature and direction of the results; thus, results of published studies may be systematically different from those of unpublished studies (Dickersin 1990). In general, studies with statistically-significant or positive results are more likely to be published than those with non-significant or negative results (Song et al., 2010). A funnel plot is used to estimate the risk of publication bias in meta-analyses (Light and Pillemer, 1984). When the true treatment effect equals zero, the biased selection of studies with significant results will produce a funnel plot with an empty area around zero. Many statistical methods (e.g., Egger’s test) have been developed to test funnel-plot asymmetry, as statistical methods may provide a more objective and accurate assessment of funnel-plot asymmetry than subjective visual assessment. The performance of tests for funnel-plot asymmetry is particularly poor when the number of studies is small, and heterogeneity is large in a meta-analysis. For this reason, it is recommended that tests for funnel-plot asymmetry should not be used in meta-analyses that include fewer than 10 studies (Sterne et al., 2011).
All analyses were performed using Comprehensive Meta-Analysis statistical software, version 2.0 (Biostat, Englewood, NJ, USA).
Results
Literature search and study characteristics
A flow diagram of study selection is shown in Figure 1. A total of 118 articles were identified in the database searches, and 58 remained after duplicates were removed. Screening of the 58 articles by title and abstract excluded 24. The full texts of the remaining 34 articles were reviewed, and 14 were excluded, the reasons for which are shown in Figure 1. Thus, 20 articles were included in the meta-analysis (Aita et al., 2014; Bahari-Kashani et al., 2013; Costa et al., 2014; Dzaja et al., 2013; Egol et al., 2008; Goehre et al., 2014; Gradl et al., 2013; Grewal et al., 2011; Hollevoet et al., 2011; Jeudy et al., 2012; Karantana et al., 2013; Kumbaraci et al., 2014; Lee et al., 2012; Loisel et al., 2015; Maire et al., 2013; Marcheix et al., 2010; McFadyen et al., 2011; Rozental et al., 2009; Tronci et al., 2013; Williksen et al., 2013).
Flow diagram of study selection.
The basic characteristics of the 20 studies are presented in Supplementary Table 1, and outcomes are summarised in Supplementary Tables 2 and 3. The 20 studies included 1,805 patients; 14 were RCTs, and six were non-randomised studies. The total number of patients ranged from 16 to 230 in the percutaneous pinning/wiring groups and from 16 to 231 in the ORIF/plating groups. The average patient age ranged from 18 to 75 years, and the percentage of male patients ranged from 6% to 70% (Supplementary Table 1).
Meta-analysis
Dash score
Thirteen studies reported DASH scores, and a fixed-effect model of analysis was used as there was no evidence of significant heterogeneity (I2 = 39.68%. Q = 18.236, p = 0.076) (Figure 2(a)). The overall analysis revealed ORIF/plating was associated with significantly better DASH scores than percutaneous pinning/wiring (pooled SDM = 0.237; 95% CI: 0.128 to 0.346; p < 0.001, Figure 2(a)). Subgroup analysis of the two non-randomised studies indicated that ORIF/plating was associated with significantly better DASH scores than percutaneous pinning/wiring (pooled SDM = 0.419; 95% CI: 0.066 to 0.771; p = 0.020). Analysis of the 10 RCTs also indicated better DASH scores with percutaneous pinning/wiring (pooled SDM = 0.218; 95% CI: 0.104 to 0.333; p < 0.001).
Forest plots showing results of meta-analysis for (a) DASH score, (b) VAS pain score, (c) PRWE, (d) procedural time, and (e) total complication rates for patients treated with EF pinning/wiring versus ORIF locking plates.
VAS pain score and PRWE
Four studies reported VAS pain data and PRWE data. Fixed-effect models of analysis were used as no evidence of heterogeneity was observed for either measure (VAS: I2 = 26.65% Q = 4.090, p = 0.252; PRWE: I2 = 45.10%, Q = 5.464, p = 0.141) (Figure 2(b) and (c)). Overall analysis revealed no significant difference of VAS pain score or PRWE score between percutaneous pinning/wiring and ORIF/plating (Figure 2(b), (c)). No significant difference in either measure was observed in subgroup analysis of RCTs and non-randomised studies.
Procedure time
Eleven studies reported procedure time, and a random-effects model of analysis was used as significant heterogeneity was present (I2 = 96.68%, Q = 301.26, p < 0.001) (Figure 2(d)). Overall analysis revealed ORIF/plating was associated with a longer procedure time than percutaneous pinning/wiring (pooled SDM = −1.863, 95% CI: −2.683 to −1.043, p < 0.001) (Figure 2(d)). Analysis of the three non-randomised studies also indicated that ORIF/plating had a longer procedure time (pooled SDM = −1.871; 95% CI: −3.632 to −0.109; p = 0.037), as did analysis of the eight RCTs (pooled SDM = −1.861; 95% CI, −2.787 to −0.935; p < 0.001).
Complication incidence
Nine studies reported complication data, and a fixed-effect model of analysis was used, as no significant heterogeneity was present (I2 = 20.22%, Q = 10.03, p = 0.263) (Figure 2(e)). Overall analysis revealed a significant difference in the total number of complications between the percutaneous pinning/wiring and ORIF/plating groups (pooled OR = 1.989; 95% CI: 1.354 to 2.923; p < 0.001) (Figure 2(e)). Subgroup analysis of three non-randomised studies indicated percutaneous pinning/wiring had a significantly higher incidence of complications than ORIF/plating (pooled OR = 3.615; 95% CI: 1.344 to 9.723; p = 0.011). An analysis of six RCTs indicated there was significant difference in the incidence of complication between the two groups (pooled OR = 1.788; 95% CI: 1.178 to 2.716; p = 0.006) .
Wound infection, carpal tunnel syndrome, nerve deficits, and complex regional pain syndrome
Overall analysis revealed that patients treated with percutaneous pinning/wiring had a significantly higher incidence of superficial wound infections (pooled OR = 5.28; 95% CI: 2.49 to 11.20; p < 0.001) and complex regional pain syndrome (pooled OR = 2.49; 95% CI: 1.21 to 5.13; p = 0.013) than those managed with ORIF/plating (Supplementary Table 4). No difference was found in the incidence of carpal tunnel syndrome or nerve deficits between the two groups.
Range of motion and radiographic outcomes
Results of the meta-analysis of ROM and radiographic outcomes are shown in Supplementary Table 5. Overall analysis indicated range of supination was significantly greater in patients treated with ORIF/plating (pooled SDM = 0.274; 95% CI: −0.520 to −0.027; p = 0.029). Subgroup analysis of non-randomised studies indicated that ORIF/plating was associated with greater grip strength (pooled SDM = −0.468; 95% CI: −0.855 to −0.082; p = 0.018), but subgroup analysis of RCTs indicated no difference in these measures between the two groups.
The overall analysis revealed that percutaneous pinning/wiring had significantly greater ulnar variance compared to ORIF plating (pooled SDM = 0.520; 95% CI: 0.223 to 0.818; p = 0.001) (Supplementary Table 5). In addition, subgroup analysis of non-randomised studies and RCTs indicated percutaneous pinning/wiring was associated with greater ulnar variance (pooled SDM = 0.797; p = 0.014 for subgroup of non-randomised studies; pooled SDM = 0.443; p = 0.010 for subgroup of RCTs).
Sensitivity analysis and publication bias
Sensitivity analyses were performed using the leave-one-out approach (Supplementary Table 6). The direction and magnitude of pooled estimates for DASH score, VAS pain score, PRWE score, procedure time, and total complications did not vary with studies removed in turn, indicating that the meta-analyses had good reliability.
No evidence of publication bias was found with respect to DASH score (Figure 3(a)) and procedure time (Figure 3(b)).
Funnel plots for (a) DASH score, (b) procedural time, and (c) total complication rate.
Quality assessment
Results of the quality assessment of the included studies are shown in Figure 4 and Supplementary Table 1. Performance and detection biases were present in the RCTs as there was no blinding, but there was little selection, attrition, or reporting bias. The NOS scores for the non-RCTs ranged from 7–9 out of 9, indicating overall high quality.
Risk of bias summary, and overall assessment of risk of bias.
Discussion
The overall results indicated that ORIF/plating was associated with significantly better DASH scores, whereas there was no difference between the two methods with respect to VAS pain scores and PRWE scores. The procedure time for ORIF/plating was longer. The overall incidence of complications, including that of complex regional pain syndrome, was higher with pinning/wiring, though the incidences of carpal tunnel syndrome and nerve defects were not different. Supination and grip strength were better with ORIF, and radiographically, ulnar variation was greater with pinning/wiring.
Several prior meta-analyses and literature reviews have attempted to determine the most appropriate treatment for distal radius fractures. A review by Meier et al. (2012) compared percutaneous K-wires with volar locking plates. The results of the studies varied remarkably, leading the authors to conclude that both methods are suitable treatments and that while locking plates may lead to an earlier functional recovery, this advantage disappears in long-term follow-up. A 2012 meta-analysis by Wei et al. (2012) compared external and internal fixation by pooling the data from 12 trials with a total of 1,011 patients (491 fractures were treated with external fixation and 520 with ORIF. ORIF was associated with better DASH scores, recovery of forearm supination, and restoration of volar tilt. Conversely, external fixation was associated with significantly better grip strength, and subgroup analyses of randomised studies showed external fixation resulted in better wrist flexion. A meta-analysis by Zong et al. (2015) comparing volar locking plates with percutaneous K-wire fixation for dorsally displaced distal radius fractures and found that ORIF with a volar locking plate resulted in statistically better DASH scores and reduced incidence of total postoperative complications, specifically superficial infections. Better grip strengths and ranges of wrist flexion and supination at 6 months postoperatively were also seen with ORIF.
We did not distinguish between younger and older patients in this analysis, and treatment outcomes with a particular method may vary with patient age. Leung et al. (2008) compared external pin fixation with plate fixation for intra-articular distal radius fractures in a group of patients with an average age of 42, none of whom were over 60. At 24 months of follow-up, plate fixation resulted in better outcomes based on the Gartland and Werley point system (p = 0.04) and the radiographic arthritis grading system (p = 0.01). Differences were greatest in patients with AO C2 fracture. The multi-centre ORCHID trial (Open Reduction and Volar Locking Plate Fixation Versus Closed Reduction and Cast Immobilisation) randomised 185 patients 65 years of age or older with AO type C distal radial fractures to ORIF or closed reposition and casting. At 1 year after treatment, there was no significant difference in Short Form (SF)-36 or EuroQol (EQ)-5D score. While DASH scores favoured ORIF, the differences were considered clinically unimportant (Bartl et al., 2014). Thirty-seven study participants (41%) who were primarily allocated to cast treatment underwent secondary surgical treatment due to loss of reduction within 2 weeks (Bartl et al., 2014).
Phadnis et al. (2012) compared fixed-angle plate fixation with K-wire fixation of distal radius AO A2, A3, and C1 fractures in patients aged 65 years and older. Functional results after 1 year were similar, though plate fixation patients were able to resume normal activities 4 weeks earlier. Diaz-Garcia et al. (2011) performed a systematic review of outcomes and complications of treating unstable distal radius fractures in the elderly with volar locking plates, non-bridging external fixation, bridging external fixation, percutaneous K-wire fixation, and cast immobilisation. Wrist arc of motion, grip strength, and DASH scores were significantly different between the groups; however, the authors suggested that the differences were not clinically meaningful. Casting resulted in the worst radiographic outcomes, which may not be meaningful because full return of function may not be as important in older patients compared to younger patients.
Cost analysis is important when comparing different procedures to achieve the same goal; however, an analysis of cost-effectiveness was beyond the scope of our study. The direct costs of ORIF are generally higher. Indirect costs include radiographs, follow-up visits, additional surgery, and length of rehabilitation. These costs need to be evaluated when examining the cost-effectiveness of different treatment methods. This is certainly a complicated issue; however, in a study performed in the United Kingdom, Karatana et al. (2013) reported that from a National Health Service perspective there was no evidence to support the cost-effectiveness of either locking plates or external fixation for the operative treatment of dorsally displaced radial fractures. Because of the socioeconomic impact of healthcare costs, further study of the cost-effectiveness of different treatment methods for displaced radial fractures is warranted.
While this meta-analysis included more studies than prior studies, there were limitations. There was heterogeneity with respect to the fracture types studied. Most included studies focused on patients with AO type A and C fractures, but several studies (Costa et al., 2014; Egol et al., 2008; Loisel et al., 2015; Maire et al., 2013) also included patients with type B fractures, and we did not perform a subgroup analysis based on fracture type. There was also heterogeneity in the procedures and materials used as well as the methods of external fixation. We did not distinguish between intra- and extra-articular fractures, and the experience level of the surgeons performing the procedures varied. Follow-up duration was not examined, and the benefits of one method over the other may diminish over time. Lastly, the situation is different in young and elderly patients. We attempted to perform a subgroup analysis based on age, but the studies did not stratify patients by age (i.e., whether they were young or elderly). Thus, the data were not available to perform this analysis. However, in all studies except one, the mean age of the patients was over 40 years. Further studies focusing on young and elderly patients are warranted.
In conclusion, the current updated meta-analysis examining the treatment of unstable distal radius fractures indicates that ORIF/plating is associated with better functional outcomes based on DASH score as well as a lower incidence of complications, including superficial wound infections and complex regional pain syndrome. These results suggest that ORIF/plating is the preferred method of managing unstable distal radius fractures.
Footnotes
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
References
Supplementary Material
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