J Orthop Sci DOI 10.1007/s00776-013-0497-8
ORIGINAL ARTICLE
Dynamic compression plating versus locked intramedullary nailing for humeral shaft fractures: a meta-analysis of RCTs and nonrandomized studies Jiezhi Dai • Yimin Chai • Chunyang Wang Gen Wen
•
Received: 5 April 2013 / Accepted: 24 October 2013 Ó The Japanese Orthopaedic Association 2013
Abstract Purpose There is no consensus regarding treatment of humeral shaft fracture. In this meta-analysis, we pooled studies to compare dynamic compression plate with locked intramedullary nail for this injury. Methods PubMed, MEDLINE, and Embase databases were searched for relevant studies published between January 1995 and July 2012. Evaluated endpoints were method-related complications and revision. Study quality was assessed, and meta-analyses were analyzed using the Cochrane Collaboration’s REVMAN 5.0 software. Results Fourteen randomized controlled (RCTs) and nonrandomized studies with 727 patients were analyzed. There was a significantly higher risk of total method-related complications and shoulder impairment resulting from locked intramedullary nailing compared with dynamic compression plating. Plating was significantly associated with a higher risk of infection and postoperative nerve palsy. There was no significant difference with respect to nonunion and revision rate. Conclusions Nailing may cause more method-related complications and shoulder impartment than plating, although it may lead to a lower risk of infection and postoperative nerve palsy. In the future, more high-quality RCTs are required to enhance these conclusions.
Introduction Humeral-shaft fracture is a quite common orthopedic injury and accounts for 1–3 % of all adult fractures [1]. It is a challenging injury for individuals, and the risk of dysfunction is substantial. Although nonsurgical treatment can be successfully performed with positive outcomes in most cases, there are occasions in which surgical treatment should to be considered, such as polytrauma, neurovascular compromise, nonunion, open and pathological fractures, and failure of nonoperative treatment [2, 3]. Advances in internal fixation modalities have improved treatment results, and various kinds of application have been reported. Two popular techniques for surgical stabilization are dynamic compression-plate fixation and locked intramedullary nailing [4]. Both procedures are different in biomechanical, physiologic, and instrumentation aspects and have definite advantages and disadvantages [5]. Although many randomized and comparative clinical studies have been published to reach evidencebased conclusions and help surgeons make rational treatment decisions, optimal treatment strategies remain challenging and controversial. In this meta-analysis, we assessed clinical results of dynamic compression plate versus locked intramedullary nail for treating humeral shaft fractures and to provide more reliable evidence for the cure of this injury.
Materials and methods Search strategy J. Dai Y. Chai (&) C. Wang G. Wen Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital, JiaoTong University, No. 600 YiShan Road, 200233 Shanghai, China e-mail: [email protected]
We performed a PubMed, MEDLINE, and Embase search of the literature on humeral shaft fracture published between January 1995 and July 2012. All searches were
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conducted using medical subject heading (MeSH) or free text word. We combined search terms with humeral shaft facture, dynamic compression plate, and intramedullary nail. Additional searches were conducted with Google Scholar and major orthopedic textbooks. No language restriction was made. Articles were reviewed by two authors independently; disagreements were resolved by debate with the senior investigator. Data extraction All relevant data regarding patient demographics, study design, injury characteristics, intervention and outcomes, rate of complication and revision, and length of follow-up were extracted by two authors independently. All disagreements were resolved by discussion. There was 100 % agreement between the two authors. Inclusion and exclusion criteria The following eligibility criteria were used in study selection: 1.
2. 3. 4. 5. 6. 7.
Published or unpublished, randomized controlled trials (RCTs) or quasi-RCT (qRCTs), and prospective or retrospective comparative studies Individuals with humeral shaft fractures and who were skeletally mature adults Polytrauma, early failure of conservative treatment, open fracture, unstable fracture Interventions comprising dynamic compression-plate or intramedullary nail fixation Outcome measures of method-related complication rate and revisions rate Minimum of ten patients Follow-up of at least 12 months.
Exclusion criteria were: (1) animal models and children; (2) injuries with pathological fractures, segmental fractures, and nonunion of the humerus; (3) data extraction or calculation was impossible.
Statistical analysis Study data were pooled and analyzed using the Cochrane Collaboration’s REVMAN 5.0 software. Treatment effects were assessed using risk ratios (RR) for dichotomous data (occurrence of total complication, revision, nonunion, infection, nerve palsy, shoulder impairment) with corresponding 95 % confidence intervals (CIs), with a fixedeffect model when appropriate using the Mantel–Haenszel test for dichotomous variables. Heterogeneity of effect size across studies was tested using Q statistics and defined as significant if P \ 0.05. We also calculated the I2 statistic, and a value [50 % indicated high heterogeneity. The random-effects model was used by DerSimonian-Laird test if there was significant heterogeneity present. To define the source of heterogeneity, we performed prespecified subgroup analyses based on study design: RCTs versus nonrandomized studies; antegrade nailing technique versus mixed antegrade and retrograde nailing techniques; different geographic region, such as North America versus Asia versus Europe. Furthermore, we assessed possible publication bias with the Begg’s rank correlation test and Egger’s regression test [6, 7]. Both analyses were performed using STATA 10.0 software. All statistical tests were two sided, and P value \0.05 was considered statistically significant. Assessment of methodological quality The methodological quality of these studies was evaluated in our meta-analysis. For RCTs or qRCTs, we assessed the risk of bias with the Cochrane Collaboration’s tool. For any nonrandomized studies, we assessed methodological quality using methodological index for non-randomized studies (MINORS) score [8]. A MINORS score [12 was considered the standard for inclusion.
Results Literature search and trial flow
Outcomes of definitions The definition of humeral shaft fractures were at least 2 cm distal to the surgical neck or 3 cm proximal to the olecranon fossa; method-related complications were infection, nonunion, implant failure, nerve injury, malunion, and delayed union, shoulder and elbow restriction, postoperative pain, impingement, and implant requiring removal; revisions comprised debridement after infection, removal of hardware after fracture healing or impingement, refixation after implant failure or nonunion, and exploration after nerve injury.
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The preliminary literature search yielded more than 2,000 possible articles: 1,762 were identified in PubMed, 205 in Embase, 15 in Cochrane, and 25 from Google Scholar. There were 571 abstracts that met criteria for initial review. This resulted in 32 articles that underwent full-text review to investigate methodology. Finally, 14 matched the inclusion criteria and were selected for this meta-analysis (Fig 1). We assessed 14 [9–22] studies for a total of 727 patients: six [10, 11, 14, 16, 19, 20] were randomized controlled trials, two [12, 17] were qRCTs, two were [15, 21] prospective comparative studies, and four were [9, 13, 18, 22]
Humeral shaft fracture Fig. 1 Flow chart
retrospective comparative studies. All studies were full text and published in English. Table 1 presents study characteristics and design, and Table 2 presents clinical outcomes. Methodological quality Methodological quality of each eligible trial was independently assessed by two authors. Table 3 describes risk of bias assessment showing trials with sample sizes ranging from 34 to 84. All eight trials reported features of patients with a similar baseline. All trials were judged as unclear regarding patient or provider blinding, as such information was not provided. Four trials [10, 11, 14, 19] reported a low risk of selection bias, as sequence generation was based on the sealed-envelope or computer-generated random number method. Two trials [17, 20] were reported as high risk because sequence generation was based on odd or hospital numbers. The other two trials [12, 16] were judged as unclear because information on sequence generation was not described. Six trials [10, 12, 14, 16, 19, 20] reported a low risk of attrition bias, with no withdrawals/dropouts or rate of loss to follow-up\5 %. The other two trials [11, 17] reported a \20 % rate of loss to follow-up and judged the field with ‘no’. Six studies that included prospective or retrospective comparative studies were assessed with MINORS score (Table 4). Two studies scored 14, one scored 16, one scored 17, and two scored 19. Two prospective comparative studies [15, 21] achieved higher scores than others, and all six studies had a low to moderate risk of bias.
Publication bias There was little evidence of publication bias regarding total method-related complications in relation to risk of intervention, as indicated by Begg’s (P = 0.827) and Egger’s (P = 0.997) tests. Subgroup analysis Table 5 presents results of subgroups stratified by characteristics of study design, nail technique, and graphic region. Subgroup analyses (RCTs versus non-RCTs) showed the test for interaction was not statistically significant (PInteraction = 0.77). Results were also not substantially affected by nail technique (PInteraction = 0.07) and geographic region (PInteraction = 0.22). Overall, the association between method-related complication and risk of surgical intervention was not substantially modified. Outcomes measures We evaluated 727 patients from 14 studies to calculate the difference in total method-related complication rate between the two types of surgical intervention (Fig. 2) by reviewing the sum of all reported complications. There was no significant heterogeneity (Pheterogeneity = 0.28) between studies, and thus a fixed-effect model was used. A metaanalysis showed that there was a significant difference between studies regarding complications of dynamic compression plate versus locked intramedullary nail (RR = 0.63, 95 % CI 0.52–0.76, Pheterogeneity = 0.28,
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123
P plate, N nail, No no report, RCT randomized controlled trial, AO Arbeitsgemeinschaft fu¨r Osteosynthesefragen
48 38 21 33 24 21 18 16 20 49 22 20 15 23 25 46 23 27 36 24 18 18 16 42 23 20 15 24 Taiwan US Canada Turkey Taiwan India India UK UK Belgium China Pakistan India India Retrospective comparative study RCT RCT Quasi-RCT Retrospective comparative study RCT Prospective comparative study RCT Quasi-RCT Retrospective comparative study RCT RCT Prospective comparative study Retrospective comparative study Lin [9] Chapman [10] McCormack [11] Kesemenli [12] Chao [13] Changulani [14] Raghavendra [15] Putti [16] Singisetti [17] Denies [18] Li [19] Iqbal [20] Kumar [21] Shah [22]
Plate
Country Design References
Table 1 Study design and characteristics
No. of patients
Nail
44.6 33 44.7 38.0 50.6 36.9 40.5 37.6 No 50.5 37.6 28.0 45.3 41.3
Mean age (years)
20.9 13 14.3 42 [24 14.3 [12 [24 12 [24 [12 12 16 [12
Mean follow-up (months)
63.0 60.7 63.6 71.7 58.3 83.0 88.9 84.1 77.0 50.5 71.1 75.0 60.0 72.3
Male %
Fracture type (AO)
A,B,C No A,B,C A,B,C A No A1,A2,A3,B2 A1,A2,A3,B1,B2 A3,B2 A,B,C A,B,C A,B,C A1,A2,A3,B2 No
Nail
Antegrade Antegrade 8 Retrograde/13 Antegrade Antegrade Antegrade Antegrade Antegrade Antegrade Antegrade 21Retrograde/28 Antegrade Antegrade Antegrade Antegrade Antegrade
Lost to follow-up
No 0% 6.8 % (P1, N2) 0% No 4.2 % (N2) 5.5 % (N2) 0% 20 % (P5, N4) 0% 4.2 % (P2) 0% 0% No
J. Dai et al.
I2 = 16 %). It was clearly observed that dynamic compression plate was superior to locked intramedullary nail regarding postoperative complications. Specified complications that included nonunion, infection, shoulder impairment, and nerve palsy were also analyzed. Pooling of nonunion data was possible across 14 studies (Fig. 3). As we found no statistical evidence of heterogeneity (Pheterogeneity = 0.97, I2 = 0 %), a fixedeffect model was used. There was no significant difference in the rate of nonunion comparing dynamic compression plate with locked intramedullary nail (RR = 0.90, 95 % CI 0.53–1.53, Pheterogeneity = 0.97, I2 = 0 %), and analysis across studies showed a trend favoring dynamic compression plate. Infection-risk analysis across 14 studies showed a statistically significant difference between various studies comparing dynamic compression plate versus locked intramedullary nail (RR = 2.11, 95 % CI 1.01–4.41, Pheterogeneity = 0.84, I2 = 0 %), and a statistically significant trend was found favoring locked intramedullary nail (Fig. 4). All studies provided data on nerve palsy resulting from plating or nailing: 24 of 357 and in 11 of 370, respectively, showing a statistically significant difference (RR = 1.82, 95 % CI 1.02–3.26, Pheterogeneity = 0.54, I2 = 0 %) (Fig. 5). Shoulder impairment was reported in 13 studies in a total of 682 patients. Pooled data indicated a statistically significant higer rate in the nail group (RR = 0.17, 95 % CI 0.08–0.35), when using a fixed-effect model (Pheterogeneity = 1.00, I2 = 0 %) (Fig. 6). A postoperative complication may cause severe outcomes and may result in surgical revision, so the rate of revision was also evaluated. There was no significant heterogeneity (Pheterogeneity = 0.51, I2 = 0 %) between studies (Fig. 7) using a fixed-effect model. Revision results in the 14 articles, with a total of 727 cases, showed no statistically significant difference between treatments (RR = 0.73, 95 % CI 0.49–1.10), but there was a trend toward a higher incidence of revision in the nailing group.
Discussion Treatment of humeral shaft fractures remains challenging and controversial, and there is still little evidence and poor consensus focusing on the optimal technique [23]. In this systematic review of 14 articles comparing clinical outcomes of dynamic compression plate with locked intramedullary nail, we attempted to resolve the conflict and make definitive conclusions about optimal therapy. Our study suggests there was a significantly higher risk of total method-related complications and shoulder impairment
Humeral shaft fracture Table 2 Number of outcomes in the included studies References
Total complication
Revision
Plate
Plate
Lin [9] Chapman [10]
Nail
Nail
Nonunion
Infection
Plate
Plate
Nail
Nail
Nerve palsy
Shoulder impairment
Plate
Plate
Nail
Nail
4
3
2
0
1
0
1
0
1
0
0
1
20
22
4
6
3
2
3
0
1
2
0
6
3
13
1
7
1
2
0
1
0
3
1
6
McCormack [11] Kesemenli [12]
6
11
1
4
1
4
0
0
4
0
0
3
Chao [13]
7
10
4
6
4
4
1
0
2
1
0
3
Changulani [14]
9
10
6
4
3
3
5
1
1
1
0
4
Raghavendra [15] Putti [16]
6 3
13 9
0 1
2 1
0 1
0 0
0 1
1 0
3 0
0 2
1 1
2 4
Singisetti [17]
8
18
2
2
1
1
2
1
1
0
0
3
Denies [18]
8
18
6
8
3
5
0
1
4
2
0
6
Li [19]
5
3
2
1
2
1
0
0
3
0
No
No
Iqbal [20]
1
2
0
1
0
0
0
0
1
0
0
2
Kumar [21]
9
13
1
2
1
1
2
1
2
0
0
2
Shah [22]
9
10
4
2
2
2
2
0
1
0
1
3
No no report
Table 3 Randomized (RCT) or quasi-randomized (qRCT) trials assessed for risk of bias References
Sequence generation
Allocation concealment
Blinding
Incomplete outcome data
Selective outcome reporting
Chapman [10]
Sealed envelope
Yes
Unclear
Yes
Yes
McCormack [11]
Sealed envelope
Yes
Unclear
No
Yes
Kesemenli [12]
Unclear
Unclear
Unclear
Yes
Yes
Changulani [14]
Sealed envelope
Yes
Unclear
Yes
Yes
Putti [16]
Unclear
Unclear
Unclear
Yes
Yes
Singisetti [17]
Odd and even hospital numbers
No
Unclear
No
Yes
Li [19]
Computer-generated random numbers
Yes
Unclear
Yes
Yes
Iqbal [20]
Odd numbers
No
Unclear
Yes
Yes
Table 4 Methodological items for nonrandomized studies References
Lin [9]
Chao [13]
Raghavendra [15]
Denies [18]
Kumar [21]
Shah [22]
1. A clearly stated aim
2
2
2
2
2
2
2. Inclusion of consecutive patients
2
2
2
2
2
2
3. Prospective collection of data
1
0
2
0
2
0
4. Endpoints appropriate to the aim of the study 5. Unbiased assessment of the study endpoint
2 0
2 0
2 0
2 0
2 0
1 0
6. Follow-up period appropriate to the aim of the study
2
2
2
2
2
1
7. Loss to follow-up \5 %
0
0
0
2
2
0
8. Prospective calculation of study size
0
0
1
0
0
0
9. Adequate control group
2
2
2
2
2
2
10. Contemporary groups
0
2
2
2
2
2
11. Baseline equivalence of groups
2
2
2
2
2
2
12. Adequate statistical analyses
1
2
2
1
1
2
Total score
14
16
19
17
19
14
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J. Dai et al. Table 5 Subgroup analysis relating to complications of humeral shaft fracture Group
No.
PHeterogeneity
I2 (%)
RR
95 % CI
P value
Total
14
0.28
16
0.63
0.52–0.76
\0.00001
RCT
8
0.23
25
0.61
0.47–0.79
0.0002
Non-RCT
6
0.29
19
0.65
0.48–0.87
0.004
PInteraction value
Study design 0.77
Technique Antegrade and retrograde Antegrade
2
0.18
44
0.38
0.21–0.69
0.001
12
0.46
0
0.69
0.56–0.84
0.0003
2
0.03
79
0.56
0.37–0.83
0.004
0.07
Geographic area North America Europe
4
0.71
0
0.52
0.36–0.75
0.0005
Asia
8
0.35
10
0.75
0.57–1.00
0.05
0.22
PInteraction probability for interaction, PHeterogeneity probability for heterogeneity, CI confidence interval, RR relative risk
Fig. 2 Comparison of total method-related complications between plate and nail
resulting from locked intramedullary nailing compared with dynamic compression plating. On the other hand, our data shows that plating was significantly associated with a higher risk of infection and postoperative nerve palsy. However, we failed to find a significant difference with respect to nonunion and revision rates, although there was a trend favoring the plate technique (RR = 0.90), even though the difference was not statistically significant. The time to eventually achieve union seemed to be shorter in the nailing group [9, 12, 14, 22], but plating was more frequently used for severely injured patients. The rate of bone healing may be decreased due to fracture distraction during antegrade nailing, insufficient fracture compression, or initial nail instability. We further note that when nonunion occurred after nailing, patients preferred to revision with plating and bone graft, thus indicating that plating
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seems to be superior to nailing in this clinical scenario [24]. Available evidence shows that intramedullary nailing is associated with a great risk of shoulder impairment (RR = 0.17, 95 % CI 0.08–0.35). Such complications ranged from impingement to frozen shoulder. Flinkkil et al. [25] claimed that the nail itself was not likely to impair shoulder function if such surgery is properly performed. This we debate: we usually found impingement when the nail was not positioned distal enough and migration when unlocked nails were used [21, 26]. There is also the possibility of distal iatrogenic fracture when a nail is used in a narrow humerus [18]. Three meta-analyses on the optimal treatment of humeral shaft fractures have been published previously [27–29]. Bhandari et al. [27] analyzed three randomized trials in 2006 and found a statistically significant difference
Humeral shaft fracture
Fig. 3 Comparison of nonunion between plate and nail
Fig. 4 Comparison of infection between plate and nail
in revision rate and shoulder impingement in favor of plating over nailing. However, the risk of nonunion, infection, or radial nerve palsy showed no significant differences in pooled analysis of three trials. In 2010, Heinieman et al. [28] updated that meta-analysis by conducting a new trial on this subject and a larger pooled patients group, thus adding statistical power to outcomes. In the metaanalysis, there was no significant difference in outcomes compared with the original review. Zheng et al. [29] performed a meta-analysis in 2012 and reported clinical results comparing antegrade locked nailing with dynamic compression plating. To reduce clinical bias and obtain upto-date evidence, their review included randomized trials using locked intramedullary nails with antegrade nailing
technique only. The available evidence, from four trials, concluded that antegrade nailing may result in higher method-related complications and shoulder impairments than plate fixation with a lower risk of infection. However, all three meta-analyses were limited by small sample sizes. A strong analysis is required using large, randomized trials to overcome these limitations. In our meta-analysis, 14 studies with a total of 727 patients were pooled to enhance statistical power and attempt to answer clinically important questions. Besides eight RCTs and qRCTs, more comparative studies were also included. The strength of our meta-analysis is its comprehensive range, assessing all major types of studies, and the thorough search strategy used. Inclusion of these
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Fig. 5 Comparison of nerve palsy between plate and nail
Fig. 6 Comparison of shoulder impairment between plate and nail
nonrandomized comparative studies, which increased bias is also discussed. Our assessment of the risk of bias was based on MINORS score, a valid instrument designed to assess methodological quality of nonrandomized surgical studies; a score [12 was considered the standard for inclusion. Six nonrandomized studies were evaluated, with a score ranging from 19 to 14 and a low to moderate risk of bias. Subgroup analysis based on RCTs versus nonrandomized studies shows no single trial substantially contributed to heterogeneity across studies (PInteraction = 0.77). This meta-analysis reported on all previous reviews and thus added statistical power to the risk estimates and increased clinical relevance of our findings with accumulative evidence. Except for similar conclusions with Zheng [29], a significant difference with respect to nerve palsy
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rate was found in our meta-analysis. We can thus conclude that there is an increased risk of nerve palsy following plate insertion. Our study has certain limitations First, missing some information was inevitable. Second, we excluded nonEnglish-language studies, introducing the possibility that estimates may be biased. Third, pooling nonrandomized comparative studies may mean that biases were inherent. Selection bias was probably the most concerning limitation in this meta-analysis due in part to the inherent difficulty of designing an RCT regarding treatment in which patients and investigator were blinded. Meanwhile, as antegrade and retrograde nailing were combined in two studies [11, 18], clinical bias was obvious. A subgroup analysis based on antegrade versus mixed antegrade and
Humeral shaft fracture
Fig. 7 Comparison of revision rate between plate and nail
retrograde nailing techniques was evaluated, and result of heterogeneity were not substantially affected (PInteraction = 0.07). However, these studies did not supply enough data in separate groups for these interventions. Thus, a welldesigned subgroup analysis comprising antegrade with retrograde nailing on outcomes will be helpful. Finally, the existence of publication bias could also affect our results. To evaluate whether publication bias was present, we performed the Begg’s test with the Egger’s test and found minimal evidence of this particular bias. Although eight RCTS and qRCTs were included in this meta-analysis with a certain level of evidence, additional large, high-quality, prospective, RCTs are also required. It will be helpful to combine and integrate outcomes of a greater number of high-quality studies to enhance statistical power.
Conclusions Available evidence demonstrates that locked intramedullary nailing may cause more method-related complications and shoulder impartment than dynamic compression plating, although it may have a lower risk of infection and postoperative nerve palsy. The risk of nonunion and revision rate was also comparable between the two techniques, with a trend favoring plating. We encourage analyses of a greater number of high-quality RCTs with proper patient allocation and blinding of patients and care providers. We also recommend that well-designed, specific subgroup analyses include antegrade versus retrograde nailing and open versus closed fracture to overcome the limitation of clinical bias.
Conflict of interest of interest.
The authors declare that they have no conflict
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ORIGINAL ARTICLE
Dynamic compression plating versus locked intramedullary nailing for humeral shaft fractures: a meta-analysis of RCTs and nonrandomized studies Jiezhi Dai • Yimin Chai • Chunyang Wang Gen Wen
•
Received: 5 April 2013 / Accepted: 24 October 2013 Ó The Japanese Orthopaedic Association 2013
Abstract Purpose There is no consensus regarding treatment of humeral shaft fracture. In this meta-analysis, we pooled studies to compare dynamic compression plate with locked intramedullary nail for this injury. Methods PubMed, MEDLINE, and Embase databases were searched for relevant studies published between January 1995 and July 2012. Evaluated endpoints were method-related complications and revision. Study quality was assessed, and meta-analyses were analyzed using the Cochrane Collaboration’s REVMAN 5.0 software. Results Fourteen randomized controlled (RCTs) and nonrandomized studies with 727 patients were analyzed. There was a significantly higher risk of total method-related complications and shoulder impairment resulting from locked intramedullary nailing compared with dynamic compression plating. Plating was significantly associated with a higher risk of infection and postoperative nerve palsy. There was no significant difference with respect to nonunion and revision rate. Conclusions Nailing may cause more method-related complications and shoulder impartment than plating, although it may lead to a lower risk of infection and postoperative nerve palsy. In the future, more high-quality RCTs are required to enhance these conclusions.
Introduction Humeral-shaft fracture is a quite common orthopedic injury and accounts for 1–3 % of all adult fractures [1]. It is a challenging injury for individuals, and the risk of dysfunction is substantial. Although nonsurgical treatment can be successfully performed with positive outcomes in most cases, there are occasions in which surgical treatment should to be considered, such as polytrauma, neurovascular compromise, nonunion, open and pathological fractures, and failure of nonoperative treatment [2, 3]. Advances in internal fixation modalities have improved treatment results, and various kinds of application have been reported. Two popular techniques for surgical stabilization are dynamic compression-plate fixation and locked intramedullary nailing [4]. Both procedures are different in biomechanical, physiologic, and instrumentation aspects and have definite advantages and disadvantages [5]. Although many randomized and comparative clinical studies have been published to reach evidencebased conclusions and help surgeons make rational treatment decisions, optimal treatment strategies remain challenging and controversial. In this meta-analysis, we assessed clinical results of dynamic compression plate versus locked intramedullary nail for treating humeral shaft fractures and to provide more reliable evidence for the cure of this injury.
Materials and methods Search strategy J. Dai Y. Chai (&) C. Wang G. Wen Department of Orthopedic Surgery, Shanghai Sixth People’s Hospital, JiaoTong University, No. 600 YiShan Road, 200233 Shanghai, China e-mail: [email protected]
We performed a PubMed, MEDLINE, and Embase search of the literature on humeral shaft fracture published between January 1995 and July 2012. All searches were
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conducted using medical subject heading (MeSH) or free text word. We combined search terms with humeral shaft facture, dynamic compression plate, and intramedullary nail. Additional searches were conducted with Google Scholar and major orthopedic textbooks. No language restriction was made. Articles were reviewed by two authors independently; disagreements were resolved by debate with the senior investigator. Data extraction All relevant data regarding patient demographics, study design, injury characteristics, intervention and outcomes, rate of complication and revision, and length of follow-up were extracted by two authors independently. All disagreements were resolved by discussion. There was 100 % agreement between the two authors. Inclusion and exclusion criteria The following eligibility criteria were used in study selection: 1.
2. 3. 4. 5. 6. 7.
Published or unpublished, randomized controlled trials (RCTs) or quasi-RCT (qRCTs), and prospective or retrospective comparative studies Individuals with humeral shaft fractures and who were skeletally mature adults Polytrauma, early failure of conservative treatment, open fracture, unstable fracture Interventions comprising dynamic compression-plate or intramedullary nail fixation Outcome measures of method-related complication rate and revisions rate Minimum of ten patients Follow-up of at least 12 months.
Exclusion criteria were: (1) animal models and children; (2) injuries with pathological fractures, segmental fractures, and nonunion of the humerus; (3) data extraction or calculation was impossible.
Statistical analysis Study data were pooled and analyzed using the Cochrane Collaboration’s REVMAN 5.0 software. Treatment effects were assessed using risk ratios (RR) for dichotomous data (occurrence of total complication, revision, nonunion, infection, nerve palsy, shoulder impairment) with corresponding 95 % confidence intervals (CIs), with a fixedeffect model when appropriate using the Mantel–Haenszel test for dichotomous variables. Heterogeneity of effect size across studies was tested using Q statistics and defined as significant if P \ 0.05. We also calculated the I2 statistic, and a value [50 % indicated high heterogeneity. The random-effects model was used by DerSimonian-Laird test if there was significant heterogeneity present. To define the source of heterogeneity, we performed prespecified subgroup analyses based on study design: RCTs versus nonrandomized studies; antegrade nailing technique versus mixed antegrade and retrograde nailing techniques; different geographic region, such as North America versus Asia versus Europe. Furthermore, we assessed possible publication bias with the Begg’s rank correlation test and Egger’s regression test [6, 7]. Both analyses were performed using STATA 10.0 software. All statistical tests were two sided, and P value \0.05 was considered statistically significant. Assessment of methodological quality The methodological quality of these studies was evaluated in our meta-analysis. For RCTs or qRCTs, we assessed the risk of bias with the Cochrane Collaboration’s tool. For any nonrandomized studies, we assessed methodological quality using methodological index for non-randomized studies (MINORS) score [8]. A MINORS score [12 was considered the standard for inclusion.
Results Literature search and trial flow
Outcomes of definitions The definition of humeral shaft fractures were at least 2 cm distal to the surgical neck or 3 cm proximal to the olecranon fossa; method-related complications were infection, nonunion, implant failure, nerve injury, malunion, and delayed union, shoulder and elbow restriction, postoperative pain, impingement, and implant requiring removal; revisions comprised debridement after infection, removal of hardware after fracture healing or impingement, refixation after implant failure or nonunion, and exploration after nerve injury.
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The preliminary literature search yielded more than 2,000 possible articles: 1,762 were identified in PubMed, 205 in Embase, 15 in Cochrane, and 25 from Google Scholar. There were 571 abstracts that met criteria for initial review. This resulted in 32 articles that underwent full-text review to investigate methodology. Finally, 14 matched the inclusion criteria and were selected for this meta-analysis (Fig 1). We assessed 14 [9–22] studies for a total of 727 patients: six [10, 11, 14, 16, 19, 20] were randomized controlled trials, two [12, 17] were qRCTs, two were [15, 21] prospective comparative studies, and four were [9, 13, 18, 22]
Humeral shaft fracture Fig. 1 Flow chart
retrospective comparative studies. All studies were full text and published in English. Table 1 presents study characteristics and design, and Table 2 presents clinical outcomes. Methodological quality Methodological quality of each eligible trial was independently assessed by two authors. Table 3 describes risk of bias assessment showing trials with sample sizes ranging from 34 to 84. All eight trials reported features of patients with a similar baseline. All trials were judged as unclear regarding patient or provider blinding, as such information was not provided. Four trials [10, 11, 14, 19] reported a low risk of selection bias, as sequence generation was based on the sealed-envelope or computer-generated random number method. Two trials [17, 20] were reported as high risk because sequence generation was based on odd or hospital numbers. The other two trials [12, 16] were judged as unclear because information on sequence generation was not described. Six trials [10, 12, 14, 16, 19, 20] reported a low risk of attrition bias, with no withdrawals/dropouts or rate of loss to follow-up\5 %. The other two trials [11, 17] reported a \20 % rate of loss to follow-up and judged the field with ‘no’. Six studies that included prospective or retrospective comparative studies were assessed with MINORS score (Table 4). Two studies scored 14, one scored 16, one scored 17, and two scored 19. Two prospective comparative studies [15, 21] achieved higher scores than others, and all six studies had a low to moderate risk of bias.
Publication bias There was little evidence of publication bias regarding total method-related complications in relation to risk of intervention, as indicated by Begg’s (P = 0.827) and Egger’s (P = 0.997) tests. Subgroup analysis Table 5 presents results of subgroups stratified by characteristics of study design, nail technique, and graphic region. Subgroup analyses (RCTs versus non-RCTs) showed the test for interaction was not statistically significant (PInteraction = 0.77). Results were also not substantially affected by nail technique (PInteraction = 0.07) and geographic region (PInteraction = 0.22). Overall, the association between method-related complication and risk of surgical intervention was not substantially modified. Outcomes measures We evaluated 727 patients from 14 studies to calculate the difference in total method-related complication rate between the two types of surgical intervention (Fig. 2) by reviewing the sum of all reported complications. There was no significant heterogeneity (Pheterogeneity = 0.28) between studies, and thus a fixed-effect model was used. A metaanalysis showed that there was a significant difference between studies regarding complications of dynamic compression plate versus locked intramedullary nail (RR = 0.63, 95 % CI 0.52–0.76, Pheterogeneity = 0.28,
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123
P plate, N nail, No no report, RCT randomized controlled trial, AO Arbeitsgemeinschaft fu¨r Osteosynthesefragen
48 38 21 33 24 21 18 16 20 49 22 20 15 23 25 46 23 27 36 24 18 18 16 42 23 20 15 24 Taiwan US Canada Turkey Taiwan India India UK UK Belgium China Pakistan India India Retrospective comparative study RCT RCT Quasi-RCT Retrospective comparative study RCT Prospective comparative study RCT Quasi-RCT Retrospective comparative study RCT RCT Prospective comparative study Retrospective comparative study Lin [9] Chapman [10] McCormack [11] Kesemenli [12] Chao [13] Changulani [14] Raghavendra [15] Putti [16] Singisetti [17] Denies [18] Li [19] Iqbal [20] Kumar [21] Shah [22]
Plate
Country Design References
Table 1 Study design and characteristics
No. of patients
Nail
44.6 33 44.7 38.0 50.6 36.9 40.5 37.6 No 50.5 37.6 28.0 45.3 41.3
Mean age (years)
20.9 13 14.3 42 [24 14.3 [12 [24 12 [24 [12 12 16 [12
Mean follow-up (months)
63.0 60.7 63.6 71.7 58.3 83.0 88.9 84.1 77.0 50.5 71.1 75.0 60.0 72.3
Male %
Fracture type (AO)
A,B,C No A,B,C A,B,C A No A1,A2,A3,B2 A1,A2,A3,B1,B2 A3,B2 A,B,C A,B,C A,B,C A1,A2,A3,B2 No
Nail
Antegrade Antegrade 8 Retrograde/13 Antegrade Antegrade Antegrade Antegrade Antegrade Antegrade Antegrade 21Retrograde/28 Antegrade Antegrade Antegrade Antegrade Antegrade
Lost to follow-up
No 0% 6.8 % (P1, N2) 0% No 4.2 % (N2) 5.5 % (N2) 0% 20 % (P5, N4) 0% 4.2 % (P2) 0% 0% No
J. Dai et al.
I2 = 16 %). It was clearly observed that dynamic compression plate was superior to locked intramedullary nail regarding postoperative complications. Specified complications that included nonunion, infection, shoulder impairment, and nerve palsy were also analyzed. Pooling of nonunion data was possible across 14 studies (Fig. 3). As we found no statistical evidence of heterogeneity (Pheterogeneity = 0.97, I2 = 0 %), a fixedeffect model was used. There was no significant difference in the rate of nonunion comparing dynamic compression plate with locked intramedullary nail (RR = 0.90, 95 % CI 0.53–1.53, Pheterogeneity = 0.97, I2 = 0 %), and analysis across studies showed a trend favoring dynamic compression plate. Infection-risk analysis across 14 studies showed a statistically significant difference between various studies comparing dynamic compression plate versus locked intramedullary nail (RR = 2.11, 95 % CI 1.01–4.41, Pheterogeneity = 0.84, I2 = 0 %), and a statistically significant trend was found favoring locked intramedullary nail (Fig. 4). All studies provided data on nerve palsy resulting from plating or nailing: 24 of 357 and in 11 of 370, respectively, showing a statistically significant difference (RR = 1.82, 95 % CI 1.02–3.26, Pheterogeneity = 0.54, I2 = 0 %) (Fig. 5). Shoulder impairment was reported in 13 studies in a total of 682 patients. Pooled data indicated a statistically significant higer rate in the nail group (RR = 0.17, 95 % CI 0.08–0.35), when using a fixed-effect model (Pheterogeneity = 1.00, I2 = 0 %) (Fig. 6). A postoperative complication may cause severe outcomes and may result in surgical revision, so the rate of revision was also evaluated. There was no significant heterogeneity (Pheterogeneity = 0.51, I2 = 0 %) between studies (Fig. 7) using a fixed-effect model. Revision results in the 14 articles, with a total of 727 cases, showed no statistically significant difference between treatments (RR = 0.73, 95 % CI 0.49–1.10), but there was a trend toward a higher incidence of revision in the nailing group.
Discussion Treatment of humeral shaft fractures remains challenging and controversial, and there is still little evidence and poor consensus focusing on the optimal technique [23]. In this systematic review of 14 articles comparing clinical outcomes of dynamic compression plate with locked intramedullary nail, we attempted to resolve the conflict and make definitive conclusions about optimal therapy. Our study suggests there was a significantly higher risk of total method-related complications and shoulder impairment
Humeral shaft fracture Table 2 Number of outcomes in the included studies References
Total complication
Revision
Plate
Plate
Lin [9] Chapman [10]
Nail
Nail
Nonunion
Infection
Plate
Plate
Nail
Nail
Nerve palsy
Shoulder impairment
Plate
Plate
Nail
Nail
4
3
2
0
1
0
1
0
1
0
0
1
20
22
4
6
3
2
3
0
1
2
0
6
3
13
1
7
1
2
0
1
0
3
1
6
McCormack [11] Kesemenli [12]
6
11
1
4
1
4
0
0
4
0
0
3
Chao [13]
7
10
4
6
4
4
1
0
2
1
0
3
Changulani [14]
9
10
6
4
3
3
5
1
1
1
0
4
Raghavendra [15] Putti [16]
6 3
13 9
0 1
2 1
0 1
0 0
0 1
1 0
3 0
0 2
1 1
2 4
Singisetti [17]
8
18
2
2
1
1
2
1
1
0
0
3
Denies [18]
8
18
6
8
3
5
0
1
4
2
0
6
Li [19]
5
3
2
1
2
1
0
0
3
0
No
No
Iqbal [20]
1
2
0
1
0
0
0
0
1
0
0
2
Kumar [21]
9
13
1
2
1
1
2
1
2
0
0
2
Shah [22]
9
10
4
2
2
2
2
0
1
0
1
3
No no report
Table 3 Randomized (RCT) or quasi-randomized (qRCT) trials assessed for risk of bias References
Sequence generation
Allocation concealment
Blinding
Incomplete outcome data
Selective outcome reporting
Chapman [10]
Sealed envelope
Yes
Unclear
Yes
Yes
McCormack [11]
Sealed envelope
Yes
Unclear
No
Yes
Kesemenli [12]
Unclear
Unclear
Unclear
Yes
Yes
Changulani [14]
Sealed envelope
Yes
Unclear
Yes
Yes
Putti [16]
Unclear
Unclear
Unclear
Yes
Yes
Singisetti [17]
Odd and even hospital numbers
No
Unclear
No
Yes
Li [19]
Computer-generated random numbers
Yes
Unclear
Yes
Yes
Iqbal [20]
Odd numbers
No
Unclear
Yes
Yes
Table 4 Methodological items for nonrandomized studies References
Lin [9]
Chao [13]
Raghavendra [15]
Denies [18]
Kumar [21]
Shah [22]
1. A clearly stated aim
2
2
2
2
2
2
2. Inclusion of consecutive patients
2
2
2
2
2
2
3. Prospective collection of data
1
0
2
0
2
0
4. Endpoints appropriate to the aim of the study 5. Unbiased assessment of the study endpoint
2 0
2 0
2 0
2 0
2 0
1 0
6. Follow-up period appropriate to the aim of the study
2
2
2
2
2
1
7. Loss to follow-up \5 %
0
0
0
2
2
0
8. Prospective calculation of study size
0
0
1
0
0
0
9. Adequate control group
2
2
2
2
2
2
10. Contemporary groups
0
2
2
2
2
2
11. Baseline equivalence of groups
2
2
2
2
2
2
12. Adequate statistical analyses
1
2
2
1
1
2
Total score
14
16
19
17
19
14
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J. Dai et al. Table 5 Subgroup analysis relating to complications of humeral shaft fracture Group
No.
PHeterogeneity
I2 (%)
RR
95 % CI
P value
Total
14
0.28
16
0.63
0.52–0.76
\0.00001
RCT
8
0.23
25
0.61
0.47–0.79
0.0002
Non-RCT
6
0.29
19
0.65
0.48–0.87
0.004
PInteraction value
Study design 0.77
Technique Antegrade and retrograde Antegrade
2
0.18
44
0.38
0.21–0.69
0.001
12
0.46
0
0.69
0.56–0.84
0.0003
2
0.03
79
0.56
0.37–0.83
0.004
0.07
Geographic area North America Europe
4
0.71
0
0.52
0.36–0.75
0.0005
Asia
8
0.35
10
0.75
0.57–1.00
0.05
0.22
PInteraction probability for interaction, PHeterogeneity probability for heterogeneity, CI confidence interval, RR relative risk
Fig. 2 Comparison of total method-related complications between plate and nail
resulting from locked intramedullary nailing compared with dynamic compression plating. On the other hand, our data shows that plating was significantly associated with a higher risk of infection and postoperative nerve palsy. However, we failed to find a significant difference with respect to nonunion and revision rates, although there was a trend favoring the plate technique (RR = 0.90), even though the difference was not statistically significant. The time to eventually achieve union seemed to be shorter in the nailing group [9, 12, 14, 22], but plating was more frequently used for severely injured patients. The rate of bone healing may be decreased due to fracture distraction during antegrade nailing, insufficient fracture compression, or initial nail instability. We further note that when nonunion occurred after nailing, patients preferred to revision with plating and bone graft, thus indicating that plating
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seems to be superior to nailing in this clinical scenario [24]. Available evidence shows that intramedullary nailing is associated with a great risk of shoulder impairment (RR = 0.17, 95 % CI 0.08–0.35). Such complications ranged from impingement to frozen shoulder. Flinkkil et al. [25] claimed that the nail itself was not likely to impair shoulder function if such surgery is properly performed. This we debate: we usually found impingement when the nail was not positioned distal enough and migration when unlocked nails were used [21, 26]. There is also the possibility of distal iatrogenic fracture when a nail is used in a narrow humerus [18]. Three meta-analyses on the optimal treatment of humeral shaft fractures have been published previously [27–29]. Bhandari et al. [27] analyzed three randomized trials in 2006 and found a statistically significant difference
Humeral shaft fracture
Fig. 3 Comparison of nonunion between plate and nail
Fig. 4 Comparison of infection between plate and nail
in revision rate and shoulder impingement in favor of plating over nailing. However, the risk of nonunion, infection, or radial nerve palsy showed no significant differences in pooled analysis of three trials. In 2010, Heinieman et al. [28] updated that meta-analysis by conducting a new trial on this subject and a larger pooled patients group, thus adding statistical power to outcomes. In the metaanalysis, there was no significant difference in outcomes compared with the original review. Zheng et al. [29] performed a meta-analysis in 2012 and reported clinical results comparing antegrade locked nailing with dynamic compression plating. To reduce clinical bias and obtain upto-date evidence, their review included randomized trials using locked intramedullary nails with antegrade nailing
technique only. The available evidence, from four trials, concluded that antegrade nailing may result in higher method-related complications and shoulder impairments than plate fixation with a lower risk of infection. However, all three meta-analyses were limited by small sample sizes. A strong analysis is required using large, randomized trials to overcome these limitations. In our meta-analysis, 14 studies with a total of 727 patients were pooled to enhance statistical power and attempt to answer clinically important questions. Besides eight RCTs and qRCTs, more comparative studies were also included. The strength of our meta-analysis is its comprehensive range, assessing all major types of studies, and the thorough search strategy used. Inclusion of these
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Fig. 5 Comparison of nerve palsy between plate and nail
Fig. 6 Comparison of shoulder impairment between plate and nail
nonrandomized comparative studies, which increased bias is also discussed. Our assessment of the risk of bias was based on MINORS score, a valid instrument designed to assess methodological quality of nonrandomized surgical studies; a score [12 was considered the standard for inclusion. Six nonrandomized studies were evaluated, with a score ranging from 19 to 14 and a low to moderate risk of bias. Subgroup analysis based on RCTs versus nonrandomized studies shows no single trial substantially contributed to heterogeneity across studies (PInteraction = 0.77). This meta-analysis reported on all previous reviews and thus added statistical power to the risk estimates and increased clinical relevance of our findings with accumulative evidence. Except for similar conclusions with Zheng [29], a significant difference with respect to nerve palsy
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rate was found in our meta-analysis. We can thus conclude that there is an increased risk of nerve palsy following plate insertion. Our study has certain limitations First, missing some information was inevitable. Second, we excluded nonEnglish-language studies, introducing the possibility that estimates may be biased. Third, pooling nonrandomized comparative studies may mean that biases were inherent. Selection bias was probably the most concerning limitation in this meta-analysis due in part to the inherent difficulty of designing an RCT regarding treatment in which patients and investigator were blinded. Meanwhile, as antegrade and retrograde nailing were combined in two studies [11, 18], clinical bias was obvious. A subgroup analysis based on antegrade versus mixed antegrade and
Humeral shaft fracture
Fig. 7 Comparison of revision rate between plate and nail
retrograde nailing techniques was evaluated, and result of heterogeneity were not substantially affected (PInteraction = 0.07). However, these studies did not supply enough data in separate groups for these interventions. Thus, a welldesigned subgroup analysis comprising antegrade with retrograde nailing on outcomes will be helpful. Finally, the existence of publication bias could also affect our results. To evaluate whether publication bias was present, we performed the Begg’s test with the Egger’s test and found minimal evidence of this particular bias. Although eight RCTS and qRCTs were included in this meta-analysis with a certain level of evidence, additional large, high-quality, prospective, RCTs are also required. It will be helpful to combine and integrate outcomes of a greater number of high-quality studies to enhance statistical power.
Conclusions Available evidence demonstrates that locked intramedullary nailing may cause more method-related complications and shoulder impartment than dynamic compression plating, although it may have a lower risk of infection and postoperative nerve palsy. The risk of nonunion and revision rate was also comparable between the two techniques, with a trend favoring plating. We encourage analyses of a greater number of high-quality RCTs with proper patient allocation and blinding of patients and care providers. We also recommend that well-designed, specific subgroup analyses include antegrade versus retrograde nailing and open versus closed fracture to overcome the limitation of clinical bias.
Conflict of interest of interest.
The authors declare that they have no conflict
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