Institutional revi

for this study.

This work was

Foundation of C

J Shoulder Elbow Surg (2014) 23, 173-181

1058-2746/$ - s

http://dx.doi.org

www.elsevier.com/locate/ymse

SHOULDER

Operative versus nonoperative treatment in themanagement of midshaft clavicular fractures:a meta-analysis of randomized controlled trials

Jing Xu, MD, Lei Xu, MD, PhD, Wendong Xu, MD, PhD, Yudong Gu, MD,Jianguang Xu, MD, PhD*

Department of Hand Surgery, Huashan Hospital, Fudan University, Shanghai, China

Background: There is no consensus on the effects of operative versus nonoperative treatment on theoutcomes of midshaft clavicular fractures in adults. We conducted a meta-analysis of randomized clinicalstudies.Materials and methods: We searched the literature and included studies that investigated the effects ofoperative versus nonoperative intervention on the outcome of midshaft clavicular fractures. Patient datawere pooled by use of standard meta-analytic approaches. For the continuous variables, the weightedmean difference was used. For dichotomous data, the relative risk was calculated.Results: Seven studies reported in 8 publications were eligible for data extraction. The pooled analysesshowed that, compared with nonoperative treatment, operative treatment led to significantly lower inci-dences of nonunion and fewer symptomatic malunions. Subgroup analysis indicated that these advantagescould be ascribed to plate fixation. Furthermore, surgery with plates resulted in significantly fewer compli-cations. Patients undergoing surgery had better Disabilities of the Arm, Shoulder and Hand and Constantscores and lower dissatisfaction with their appearance.Conclusion: In the management of midshaft clavicular fractures, surgery is superior to nonoperative treat-ment. Surgery with plates results in lower incidences of nonunion, fewer total complications, and fewersymptomatic malunions compared with nonoperative treatment.Level of evidence: Level II, Meta-Analysis.� 2014 Journal of Shoulder and Elbow Surgery Board of Trustees.

Keywords: Midshaft clavicular; plating; intramedullary fixation; nonoperative treatment; meta-analysis

Traditionally, midshaft clavicular fractures have beenmanaged nonoperatively, even when substantially dis-placed.7 Recent studies have shown a greater prevalenceof nonunion, symptomatic malunion, and poor functionaloutcomes after nonsurgical management of displacedfractures. Although midshaft clavicular fractures have

ew board or ethical committee approval was not required

supported by funding from the National Natural Science

hina (grant 30901521).

ee front matter � 2014 Journal of Shoulder and Elbow Surgery

/10.1016/j.jse.2013.06.025

always been managed conservatively, surgery isbecoming increasingly accepted as the optimal treatmentmethod for displaced midshaft clavicular fractures.2,10-12

A few randomized controlled trials (RCTs) concerningsurgical versus nonoperative treatment have been publishedin recent years. However, the relatively small sample size in

*Reprint requests: Jianguang Xu, MD, PhD, Department of Hand

Surgery, Huashan Hospital, Fudan University, No. 12, Wulumuqi Zhong

Road, Shanghai, 200040 China.

E-mail address: x.jianguang@yahoo.com (J. Xu).

Board of Trustees.

174 J. Xu et al.

each published study made the results inconclusive andcontroversial. Recently, a meta-analysis of RCTs comparedoperative versus nonoperative approaches for the treatmentof midshaft clavicular fractures.14 Regrettably, analysisof publication bias, which is an essential part of a meta-analysis, was not performed in that study, thereby makingthe conclusions questionable. Another meta-analysis,without assessment of publication bias, only included 4RCTs.24 Moreover, additional RCTs have been publishedsince these earlier meta-analyses,15,21 which makes thepresent meta-analysis a more precise estimation.

Materials and methods

Search strategy

This meta-analysis was carried out following the PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, which was established to help authors reporta wide array of systematic reviews to assess the benefits anddisadvantages of health care interventions.13 We performeda literature search without language restrictions on July 22, 2012,and an updated literature search was performed on February 12,2013, using the phrase ‘‘clavicular fractures’’ with the limits‘‘randomized controlled trial.’’ A second search was performedusing the phrase ‘‘clavicle fractures’’ with the limits ‘‘randomizedcontrolled trial’’ using PubMed (1949-2013), Ovid’s Medline(1946-2013), and Medline’s in-process and other non-indexedcitations (updated up to February 12, 2013), as well as Web ofKnowledge and Embase (1966-2013). Further searches using thesame keywords and limitations did not identify any additionalreferences.

We also conducted a search of the Cochrane Central Registerof Controlled Trials. Reference lists of review articles werescanned to find additional publications. In addition, reference listsof all primary articles and previously published systematic reviewsand meta-analyses were manually searched for additional eligiblestudies. Duplicates were removed. Information was carefullyextracted from all eligible publications independently by 2reviewers (J.X. [first author] and L.X.); disagreements wereresolved by discussion between them. If a consensus could not bereached, a third investigator (W.X.) adjudicated the disagreements.The search results were then screened based on the followinginclusion criteria: (1) the studies had to be RCTs on patients withmidshaft clavicular fractures, (2) the studies had to compareoperative with nonoperative treatment, and (3) the patients wereaged at least 16 years. Exclusion criteria included (1) non-randomized trials, (2) studies concerning adolescent fractures, and(3) fracture in the proximal or distal third of the clavicle. TheJadad scale was used to assess the quality of included RCTs,where a score of less than 3 indicates low quality.8

Statistics

The primary outcome of our analysis was the incidence of nonunion,which is determined using radiographs or, in some cases, withadditional computed tomography scans. The secondary outcomewas the functional outcome, measured with the Disabilities of the

Arm, Shoulder and Hand (DASH) score and the Constant score.Furthermore, data on complications and patient dissatisfaction werecollected.Weattempted to contact the authors of the studies includedto obtain missing information. For studies that did not presentstandard deviations, the standard deviations were calculated fromthe P value or confidence interval (CI) following the guidance of theCochrane Handbook for Systematic Reviews of Interventions.6

For the meta-analysis of continuous variables, the weightedmean difference with 95% CI was used. For dichotomous vari-ables, the relative treatment effect was expressed as relative risk(RR) with 95% CI.4 Statistical heterogeneity was investigatedwith the c2 test and quantified with the I2 statistic. We anticipatedthe presence of clinical heterogeneity based on the findings thatthe fixation methods and implants used in surgery varied amongthe RCTs. Because the test for heterogeneity had low statisticalpower, we assumed the presence of heterogeneity a priori and usedthe random-effects model in all the analyses. Subgroup analysesof plate or intramedullary fixation were conducted when possible.A sensitivity analysis was performed by detecting the effect ofeach individual study on the pooled effect size. Funnel plots andEgger tests were used to assess possible publication bias. A funnelplot is a simple scatter plot of the intervention effect estimatesfrom individual studies against some measure of each study’s sizeor precision. It assumes that the largest studies will be near themean and smaller studies will be spread on both sides of the mean.Variation from this assumption can indicate publication bias. P <.05 was considered statistically significant. Analyses were per-formed with the Stata/SE 10.0 program (StataCorp, CollegeStation, TX, USA).

Results

Selected studies and characteristics

Potentially relevant citations were identified and screened,of which only 6 published RCTs3,9,15,19,21,22 and 1abstract20 met the inclusion criteria and were selected forthis meta-analysis (Fig. 1 and Table I). One study17

provided 2-year follow-up data of the study by the Cana-dian Orthopaedic Trauma Society.3 In this analysis, the 2publications were considered as reports of 1 study and werecombined. Among the RCTs, 4 compared plate fixationwith nonoperative treatment3,15,20,21 and 3 comparedintramedullary fixation with nonoperative treatment.9,19,22

The level of evidence for each article was graded witha score from 1 to 3 according to the Jadad score.8 A totalof 471 patients were included in the analysis. Sample sizesof the studies ranged from 50 to 111 patients. Of thepatients, 231 were randomized to receive surgery and 240to nonoperative treatment. Among individuals treatedsurgically, 146 were treated with plate fixation and 94 withintramedullary fixation. One study was a multicenterRCT,3 and the others were single-center RCTs.2,9,19-22

Allocation concealment was reported in 5 trials3,9,15,19,21

and not stated in the other trials.20,22 Because of theobvious nature of the intervention, no trials were doubleblind.

Figure 1 Flowchart of meta-analysis. CENTRAL, Cochrane Central Register of Controlled Trials.

Operation versus non-operation in clavicular fractures 175

Effects of operative versus nonoperativemanagement on incidence of nonunion

All 7 studies reported nonunion incidence. The incidenceof nonunion in both the operative and nonoperative groupsreported by Witzel22 was zero, so this study was excludedwhen we performed the analysis. The pooled results of ourprimary outcome measure, nonunion incidence, presenteda statistically significant difference favoring operativeover nonoperative treatment (RR, 0.25; 95% CI, 0.10-0.67; P < .01). Subgroup analysis concerning fixationmethods showed that plate fixation (RR, 0.22; 95% CI,0.07-0.66; P < .01), but not intramedullary fixation (RR,0.42; 95% CI, 0.06-3.04; P ¼ .39), was associated witha reduced risk in comparison with nonoperative treatment(Fig. 2).

Effects of operative versus nonoperativemanagement on functional scores

DASH data at 3, 6, and 12 months postoperatively areavailable from2 or 3 studies from the total 7 studies (Table II).Only Schemitsch et al17 reported DASH scores at 24 months,which showed that DASH scores in patients in the operativegroupwere superior to those in the nonoperative group, sowewere not able to perform a pooled analysis. For Constantscores, the pooled analysis based on 2 or 3 studies indicated

that operative treatment was superior to nonoperative treat-ment at 6, 12, and 24 months postoperatively but not at 3months postoperatively (Table II). Because of the limitednumber of studies, we could not perform subgroup analysescomparing surgery using plates or intramedullary implantswith nonoperative treatment.

Effects of operative versus nonoperativemanagement on incidence of complications

Pooled results from 6 studies showed that the totalcomplication rate after surgery was not significantly dif-ferent in comparison with nonoperative treatment (RR,0.78; 95% CI, 0.56-1.07; P ¼ .12). To further explore theeffects of different surgical methods in comparison withnonoperative treatment, subgroup analyses indicated thatthe total number of complications after surgery using plateswas less than that in nonoperative cases (RR, 0.70; 95% CI,0.54-0.91; P < .01), whereas no significant difference in thetotal complication rate was detected between surgery usingintramedullary fixation and nonoperative treatment (RR,1.78; 95% CI, 0.28-11.46; P ¼ .55) (Fig. 3).

A statistically significant difference in symptomaticmalunion was found in favor of surgical treatment. Furthersubgroup analysis showed that surgery with plates butnot intramedullary fixation was superior to nonoperativetreatment. Regarding the incidence of further surgical

Table I Demographic characteristics of clinical trials included in analysis

Authors Age (y) No. of patients(operative/nonoperative)

No. of femalepatients(operative/nonoperative)

Operativetreatment

Nonoperativetreatment

Follow-uptime (mo)

Outcomes measured Jadadscore8

Virtanen et al,21

201218-70 28/32 4/4 AO/ASIF stainless

steel reconstructionplates

Sling 12 Nonunion, DASH andConstant scores, pain,fracture healing, andcomplications

3

Mirzatolooei,15

201118-65 26/24 20/21 3.5-mm reconstruction

platesSling and elasticcotton band

12 Nonunion, DASH andConstant scores,patient satisfaction,range of motion ofshoulder, andcomplications

2

Smekal et al,19

200918-65 30/30 4/4 Elastic stable

intramedullary nailsSling 24 Nonunion, DASH and

Constant scores,patient satisfaction,and complications

3

Judd et al,9

200917-40 29/28 2/3 Modified Hagie pins Sling 12 Nonunion, SANE and

L’Insalata functionalscores, andcomplications

2

COTS,3,17 2007 16-60 62/49 9/15 Limited-contact dynamiccompression plates,reconstructionplates, precontouredplates, other plates

Sling 12 Nonunion, DASH andConstant scores,patient satisfaction,range of motion,complications, andappearance ofshoulder

3

Witzel,22 2007 18-72 35/33 13/10 Intramedullary titaniumpins

Backpackassociation

8-26 Nonunion, range ofmotion, pain,radiologic results,force measurement,and resumption ofphysical activity

1

Smith et al,20

2001Adults 30/35 d Small-fragment plates Sling Mean, 18.5 Nonunion and patient

satisfaction1

COTS, Canadian Orthopaedic Trauma Society; SANE, Single Assessment Numeric Evaluation.

176

J.Xu

etal.

Figure 2 Assessment of effects of operative versus nonoperative treatment on incidence of nonunion. Squares with diamonds indicateweighting given to the trial in the overall pooled estimate, taking into account the number of participants and the amount of interstudyvariation (heterogeneity); rhombus, combined effect size. COTS, Canadian Orthopaedic Trauma Society.

Table II Comparison of operative and nonoperative treatments with respect to outcomes of DASH and Constant scores

Parameter Time No. of studies No. ofparticipants

WMD 95% CI P value Treatment favored

O N

DASH score 3 mo 3 118 104 �4.81 �8.90 to �0.63 .02 O6 mo 2 9 79 �3.43 �6.05 to �0.80 .01 O12 mo 2 114 98 �7.90 �13.62 to �2.18 <.01 O24 mo 1 52 43 �7.3 �13.49 to �1.11 .02 O

Constant score 3 mo 2 88 74 3.19 �5.39 to 11.77 .47 O6 mo 2 92 79 7.75 4.59 to 10.92 <.01 O12 mo 3 114 98 5.89 1.14 to 10.64 .02 O24 mo 2 82 73 4.47 2.48 to 6.46 <.01 O

N, Nonoperative treatment; O, operative treatment; WMD, weighted mean difference.

Operation versus non-operation in clavicular fractures 177

intervention, the pooled data showed that the need forfurther surgery was less in the nonoperative group. Pooleddata regarding delayed union refractures or implant failureand infection showed no significant difference betweenoperative and nonoperative treatments (Table III).

Effects of operative versus nonoperative treatmenton rates of patient dissatisfaction with functionaloutcome and appearance of shoulder

Our meta-analysis indicated no significant difference inrates of patient dissatisfaction with their outcome betweenthe operative and nonoperative groups (RR, 1.31; 95% CI,0.19-9.27; P ¼ .79). However, regarding the rate ofdissatisfaction with shoulder appearance, surgery wassuperior to nonoperative treatment (RR, 0.44; 95% CI,0.23-0.83; P ¼ .01) (Fig. 4). Because of the limited studies

available, we were unable to perform subgroup analyses tocompare surgery with plates or intramedullary implantswith nonoperative treatment.

Sensitivity analysis and publication bias analysis

For the data on the total complication rate that most of thestudies included in their analyses, the influence of anyindividual study on the overall RR was evaluated. Noindividual study affected the overall RR dominantlybecause omission of any single study did not make a largedifference (Fig. 5). The shape of the funnel plot issymmetric, indicating that the largest studies are nearaverage, with small studies spreading on both sides of theaverage, or mean, in which publication bias is unlikely(P ¼ .71) (Fig. 5). Moreover, the Egger test suggested theabsence of any publication bias (P ¼ .14).

Figure 3 Assessment of complication rate of operative versus nonoperative treatment. Squares with diamonds indicate weighting given tothe trial in the overall pooled estimate, taking into account the number of participants and the amount of interstudy variation (heteroge-neity); rhombus, combined effect size. COTS, Canadian Orthopaedic Trauma Society.

Table III Effect of operative versus nonoperative treatments on complication rates

Complications Method No. of studies Participants RR 95% CI P value Treatmentfavored

O N

Symptomatic malunion Plates 4 146 140 0.24 0.10-0.55 <.01 ONail 3 94 93 0.21 0.01-4.26 .31Overall 7 240 231 0.24 0.11-0.53 <.01 O

Delayed union Plates 1 28 32 3.19 0.35-29.10 .30Nail 2 59 58 0.56 0.04-7.24 .66Overall 3 87 90 1.04 0.15-7.41 .97

Refractures or implant failure Plates 3 116 105 1.78 0.43-7.46 .43Nail 2 59 58 2.65 0.42-16.84 .30Overall 5 175 163 2.07 0.67-6.41 .21

Infection Plates 3 116 105 3.86 0.45-33.17 .22Nail 2 59 58 10.47 0.62-178.27 .10Overall 5 175 163 5.56 1.00-30.84 .05

Surgery intervention Plates 3 116 105 2.47 0.72-8.43 .15Nail 2 59 58 2.21 0.74-6.60 .16Overall 5 175 163 2.19 1.07-4.51 .03 N

N, Nonoperative treatment; O, operative treatment.

178 J. Xu et al.

Discussion

The clinical studies included in our meta-analysis useda variety of different outcome measures. This variability inthe outcome measures used suggests the need for a furtherstandard protocol to be established when reporting theseresults of treatment for midshaft clavicular fractures.

Our results showed that surgical treatment leads toa significantly lower prevalence of nonunion; furthersubgroup analysis indicated that the advantage could beattributed to plate fixation but not to intramedullary fixa-tion. This could be explained by the fact that surgical

treatment with plates is more reliable and reproducible inachieving an anatomic reduction than nonoperative treat-ment. A biomechanical study of plates versus intra-medullary devices for midshaft clavicle fixation wasperformed by Golish et al,5 which indicated that the clinicalrelevance is that plate fixation may provide a strongerconstruct for early rehabilitation protocols that focus onrepetitive movements.

Our results indicate that surgery leads to significantlybetter DASH scores compared with nonoperative treatmentat early follow-up and that this advantage continues up to24 months. Consistently, we found that the surgical group

Figure 4 Assessment of patient dissatisfaction after operative versus nonoperative treatment. Top, Assessment of patient dissatisfactionwith outcomes of operative versus nonoperative treatment. Bottom, Assessment of patient dissatisfaction with appearance after operativeversus nonoperative treatments. Squares with diamonds indicate weighting given to the trial in the overall pooled estimate, taking intoaccount the number of participants and the amount of interstudy variation (heterogeneity); rhombus, combined effect size. COTS, CanadianOrthopaedic Trauma Society.

Figure 5 Sensitivity analysis and publication bias analysis of meta-analysis. (A) Influence of individual studies on summary RR. Themiddle vertical line indicates the overall RR, and the left and right vertical lines indicate its 95% CI. Every circle indicates the pooled RRwhen the study on the y-axis is omitted in this meta-analysis. The 2 ends of each dotted line represent the respective 95% CI. (B) Beggfunnel plot of studies included in analysis. The vertical axis represents the log [RR], and the horizontal axis indicates the standard error ofthe log [RR]. The horizontal line and sloping lines in the funnel plot represent the effects summary RR and the expected 95% CI for a givenstandard error, respectively. Each circle represents an independent study. COTS, Canadian Orthopaedic Trauma Society.

Operation versus non-operation in clavicular fractures 179

had better Constant scores when assessed at 6 to 24months’ follow-up. However, we were unable to draw anyconclusions regarding whether plate or intramedullary

fixation was more advantageous because of the limiteddata available. Because better functional results can beexpected in the early period with surgery, and the functional

180 J. Xu et al.

improvement is stable, surgical treatment should beconsidered for patients requiring a faster return to functionafter injury.

Our pooled data show that although there was nostatistically significant difference regarding total compli-cations between the operative and nonoperative groups,subgroup analysis indicated that surgery with plates had theadvantage. Furthermore, compared with nonoperativetreatment, operative treatment led to a statistically signifi-cant reduction in the incidence of symptomatic malunions.Subgroup analysis indicated that these advantages shouldbe ascribed to plate fixation, and these results are consistentwith the previously mentioned nonunion incidence data.Our results regarding complications are novel and differfrom those of previous meta-analyses, which yielded noconsistent results regarding the overall rate of complica-tions between treatments and in which subgroup analysisregarding fixation methods was not performed.14,24 Withthe inclusion of all eligible studies in the analysis andcorrection for improper data, sensitivity analysis showedthat our results are stable. Because the funnel plot andEgger test showed no publication bias, we believe that ourresults are more precise than others recently published. Onthe other hand, our results show that operative patients aremore likely to have the need for further surgery, andpatients should be aware of this risk before making a deci-sion to accept surgery.

Even an unsightly scar is an adverse consideration forpatients who accept operative treatment, but the availabledata indicated that the incidence of dissatisfaction inpatients who underwent operative treatment was lower.This would seem to indicate that an asymmetric or droopyshoulder is more likely to trouble patients than a scar.However, no clear conclusions can be drawn regardingyoung or female patients because of the lack of age- andgender-specific data.

Certain limitations of our meta-analysis need to beaddressed. First, the heterogeneity of the patients’ agesshould be expected. It has been reported that increasing ageis a risk factor for nonunion in cases of displaced midshaftclavicular fractures treated with Knowles pin fixation23;however, there were no studies included in our meta-analysis that explored the effects of age on the outcomes,so we were unable to perform a pooled analysis. Further-more, the preoperative fracture pattern was found to besignificantly related to implant failure,18 but our meta-analysis could not show fracture type–specific effectsbetween operative and nonoperative treatments because ofthe limited data of the studies. Finally, it is unclear whetherthe clinical benefits of surgery outweigh the surgical risksand justify the costs associated with operative treatment.Pearson et al16 conducted a study based on the CanadianOrthopaedic Trauma Society study3 and showed thatopen reduction–internal fixation is most cost-effective forpatients who are sensitive to mild functional deficits andstrongly value a more rapid return to normal function,

particularly in low-cost environments. Similarly, a retro-spective case-control study indicated that patients withdisplaced clavicle fractures benefit financially from openreduction–internal fixation; their higher initial hospital billwas balanced by less income loss, resulting in a costsavings of $5,091.33.1 However, cost-effectiveness was notmeasured in the other included studies, so we were unableto perform a pooled analysis regarding this factor. Lastly,only 7 RCTs matched our inclusion criteria, 3 of whichwere of low quality (Jadad score <3). The small samplesizes and study design limitations of included studiesmay have caused us to fail to recognize a differencebetween the operative and nonoperative treatment groups(type II error) (eg, the lack of effect of intramedullaryfixation on nonunion).

Conclusions

We conclude that on the basis of the current clinicalreports, in the management of midshaft clavicular frac-tures, operative treatment is superior to nonoperativetreatment. Surgery with plates results in a lower inci-dence of nonunion and fewer total complications andsymptomatic malunions than nonoperative treatment.Further research protocols should be well conceived, andclinical research could compare the effects of operativeand nonoperative treatment in multicenter trials ondifferent types of fractures, in populations comprisingboth young and old patients, with parallel cost-effectiveanalysis to attain more robust evidence.

Disclaimer

The authors, their immediate families, and any researchfoundations with which they are affiliated have notreceived any financial payments or other benefits fromany commercial entity related to the subject of thisarticle.

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