Clavicle Fractures in2010: Sl ing/Swathe orOpen Reduction andInternal Fixation?

Michael D. McKee, MD, FRCS(C)

KEYWORDS

� Clavicle � Fixation � Randomized trials � Evidence-based� Comparative studies � Review

m

Clavicle fractures are common, and they compriseclose to 3% of all fractures seen in fracture clinics.Midshaft fractures account for approximately 80%of all clavicle fractures and are the focus of thisarticle. Distal clavicle fractures are next mostcommon, consisting of 15% of clavicle fractures,and medial third fractures are the least common,making up 5% of injuries. Distal third and medialthird fractures are distinct entities and have a sepa-rate set of features requiring different approachesto imaging, diagnosis, and treatment comparedwith middle third fractures.

Traditionally, even widely displaced midshaftclavicle fractures have been treated nonopera-tively based on several large studies that demon-strated excellent functional outcome with variousmethods of closed reduction and nonoperativetreatment. In the past, most of the controversysurrounded the optimal method (if any) of nonop-erative treatment, with various investigators sup-porting simple sling treatment, figure-of-eightbandaging, or other types of external support.Operative methods were deemed to have a highcomplication rate and little role in the primary treat-ment of fractures. The nonunion rate after nonop-erative treatment was described as beingapproximately 1%, even in widely displaced frac-tures, and malunion was described as being ofradiographic interest only.1–5

However, recent studies have reported signifi-cantly different outcomes with regard to

The devices that are the subject of this article are FDA aNothing of benefit was received with regard to this artiDivision of Orthopaedics, Department of Surgery, St MQueen Street East, Suite 800, Toronto, ON M5C 1R6, CanE-mail address: mckeem@smh.toronto.on.ca

Orthop Clin N Am 41 (2010) 225–231doi:10.1016/j.ocl.2009.12.0050030-5898/10/$ – see front matter ª 2010 Elsevier Inc. All

completely displaced fractures of the clavicle.Studies that have used patient-based outcomemeasures (as opposed to the more traditionalsurgeon-based or radiographic outcomes) havedescribed an unsatisfactory outcome rate of25% to 31%.5–15 Multiple comprehensive,prospective studies have clearly shown thenonunion rate in this setting to be up to 21%,exponentially higher than previously reported. Inaddition, a significant number of patients with mal-united fractures have ongoing symptomatologywith orthopedic, neurologic, and functionalcosmetic deficits in a characteristic pattern; itwould appear that clavicular malunion is a distinctclinical entity.

There are multiple potential explanations for theincreased rate of poor outcome including survivalof critically injured trauma patients with more severefracture patterns, increased patient expectations ofhaving a normal shoulder after injury, comprehen-sive follow-up (including patient-oriented outcomemeasures), and excluding children (with their inher-ently good prognosis) from analysis.

These findings spurred further investigation intocomparative studies examining the role of primaryoperative fixation (usually consisting of compressionplating or intramedullary nailing) in the treatment ofdisplaced midshaft fractures of the clavicle. Thesecomparative investigations including those exam-ining different methods of closed treatment, opera-tive versus nonoperative treatment, and different

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methods of operative fixation are the focus of thisevidence-based medicine article.

TREATMENT OPTIONS

Although a variety of treatment options have beendescribed for the treatment of midshaft fracturesof the clavicle, they can be summarized in 3 maintypes: nonoperative, open reduction and internalfixation with a plate, and intramedullary pin fixation(through either an open or closed reduction tech-nique). These options, and the articles supportingthem, are described in the following sections.

Nonoperative

Nonoperative care is the treatment of choice formost fractures of the clavicle shaft, especiallythose that are minimally displaced or undisplacedor those that occur in elderly, ill, noncompliant, orsedentary individuals in whom the risk of surgicalintervention is too high or the potential benefit istoo low. There have been multiple different tech-niques and devices described to obtain and main-tain a satisfactory nonoperative reduction ofa displaced midshaft fracture of the clavicle.However, there is little or no convincing evidencethat any significant improvement can be made tothe original position of the fracture in most cases,and one must typically accept the displacementseen on injury films. Although some temporaryimprovement in alignment may well occur withvarious techniques, such as the figure-of-eightbandage (traditionally popular in North America),there is little evidence that this device can maintaina closed reduction of a displaced clavicle fracture.

Currently, immobilization with a simple sling untilthe patient is comfortable enough to begina gradual return to preinjury activities is the com-monest nonoperative treatment choice. A random-ized trial by Andersen and colleagues15 examinedthe functional and radiographic results after theuse of a figure-of-eight bandage versus a simplesling for the treatment of displaced midshaft frac-tures of the clavicle. They found no significantdifference between the 2 groups at final follow-up in either radiographic or functional outcome.Also, patients preferred the sling (2/27 dissatisfiedwith sling versus 9/34 dissatisfied with figure-of-eight bandage, P 5 .09). For this reason, it isreasonable to consider nonoperative treatmentgroups in comparative studies as one homoge-nous group in terms of outcome, despite the factthat there may be some differences in the type ofnonoperative therapy used.

The results of nonoperative treatment werepreviously thought to be satisfactory in most cases,but modern studies with patient-based outcome

measures have revealed significant deficits. Hilland colleagues7 reported a high degree of residualpatient dissatisfaction after nonoperative treatmentof displaced midshaft clavicle fractures usinga patient-based outcome tool. They founda nonunion rate of 15%, and overall 31% ofpatients were dissatisfied with their outcome. Ina study examining 225 clavicle fractures, Nordqvistand colleagues8 described good results after long-term follow-up with 185 good, 39 fair, and only 1poor result. It should be noted that in the subcate-gory of displaced, comminuted fractures 27% ofpatients rated their shoulder as fair and this corre-sponds to the dissatisfied group (31%) in Hill’sstudy. Nowak and colleagues6 reported that 46%of 208 patients treated nonoperatively hadshoulder sequelae at 9- to 10-year follow-up. Ina study from the fracture group in Edinburgh, Rob-inson and colleagues4 reported on a prospective,consecutive series of 868 patients with claviclefractures, 581 of whom had a midshaft diaphysealfracture, and described a nonunion rate of 21% indisplaced comminuted midshaft fractures. Brinkerand colleagues5 analyzed the data from that articleand suggested a nonunion rate of 33% for dis-placed comminuted fractures in men.

What is clear from these articles is that a signifi-cant percentage of young active patients with dis-placed midshaft clavicle fractures treatednonoperatively will develop symptomatic nonunionor malunion. These patients complain of a short,droopy, ptotic, asymmetric shoulder with ortho-pedic (weakness, rapid fatiguability), neurologic(thoracic outlet), and functional cosmetic (difficultywearing backpacks, straps, etc) symptomatology.

Open Reduction and Plate Fixation

Open reduction and plate fixation of displaced mid-shaft fractures of the clavicle using modern precon-toured implants and techniques has been welldescribed with a high degree of success and lowcomplication rate.12–14 Older reports of operativefixation that described a high failure rate and anunacceptable level of complications were plaguedby selection bias (only the worst, comminuted,open fractures received surgery), poor soft-tissuehandling, and fixation methods (cerclage wires orshort, weak plates) that could reasonably bedescribed as suboptimal by modern standards.1–3

Modern studies have reported significantlyimproved results after plate fixation. Smith andcolleagues16 reported union in all of the 30 casestreated in this manner in a prospective trial, Collingeand colleagues17 reported union in 39 of 42 casestreated with anterior/inferior plating, and Poigen-furst and colleagues12 reported excellent results in

Clavicle Fractures in 2010: Sling/Swathe or ORIF? 227

122 consecutive cases treated with superiorplating. The operative group in the randomized clin-ical trial performed by the Canadian OrthopaedicTrauma Society (COTS) reported only 2 nonunionsout of 62 cases treated with plate fixation. Althoughthere are disadvantages with this techniqueincluding plate prominence (and subsequent hard-ware removal) and potential wound complicationsfrom the dissection required, in most modern seriesthe incidence is low. In addition, precontouredanatomic plates are now available that minimizelocal irritation and decrease the need for hardwareremoval. A careful 2-layer (deltotrapezial fascia/pla-tysma muscle and skin/subcutaneous tissue)closure can decrease the incidence and morbidityof potential infection. Although it remains controver-sial, antero-inferior placement of the plate has beenadvocated as a means of decreasing local irritation(as well as avoiding neurovascular structures whiledrilling).17

Intramedullary Pin Fixation

Various retrospective reviews describe variousmethods of intramedullary pinning of the clav-icle.18–23 The main intrinsic difficulty is that oftrying to perform intramedullary fixation of a curvedbone with a straight intramedullary device. Thetheoretical advantages of this technique aremany and include minimal soft tissue dissectionat the fracture site, less soft tissue prominence ofthe hardware, and a reduced refracture ratewhen compared with plate fixation. If the pindoes need to be removed, it can be done througha small incision with minimal dissection, oftenunder local anesthetic. Chuang and colleagues23

reported success in 30 of 31 midshaft clavicle frac-tures treated with closed reduction and an intra-medullary screw technique. Boehme andcolleagues19 reported similar results in a seriesthat included both fractures and nonunions. Inaddition, newer techniques describe insertion ofsmaller diameter elastic or flexible nails usinga completely closed method. The fracture isreduced under image intensifier control and thepin is passed through a medial entry portal, acrossthe fracture site, and impacted laterally.18,24

Disadvantages of this technique include difficultyin controlling shortening and rotation at the frac-ture site, especially if there is significant comminu-tion. This may explain the inconsistent results seenwith this technique when compared with nonoper-ative care (see later section).

COMPARATIVE STUDIES

While there are many retrospective, single-armstudies that describe results after the treatment of

various types of clavicle fractures, there are onlyrelatively few prospective or randomized trials pub-lished. This section details high-quality comparativestudies on a specific subgroup of injuries:completely displaced midshaft fractures of the clav-icle in young (16–60 years of age) healthy patients.

Sling Versus Figure-of-Eight Bandage

There is evidence (2 randomized trials and multipleretrospective reviews) that a sling is as effective asa figure-of-eight bandage in immobilizing fracturesof the clavicle and is favored by patients.15,25

There is no conclusively proven difference in radio-graphic or functional outcome regardless of themethod of nonoperative treatment chosen. Lenzaand colleagues,25 in a Cochrane Database Reviewof 234 nonoperatively treated patients from 3randomized controlled trials, concluded that therewas no evidence to support one nonoperativetechnique over another. For this reason theauthors’ current treatment of choice for displacedmidshaft fractures of the clavicle is a simple slingfor comfort, followed by early range of motionexercise as pain diminishes.

Plate Fixation Versus Nonoperative Care

A multicenter, prospective, randomized clinicaltrial on this topic was performed by the COTS.One hundred thirty-two patients with completelydisplaced fractures of the midshaft clavicle wererandomized to nonoperative (sling) or operative(open reduction and plate fixation) treatment.26

Although, as with most young male trauma popu-lations, a significant number of patients were lostto follow-up, 111 patients were analyzed ata year after injury. Analysis of both surgeon- andpatient-based outcome scores revealed signifi-cantly improved Constant and disabilities of thearm, shoulder and hand (DASH) scores in theoperative group (Figs. 1 and 2) with fewernonunions (2/62 vs 7/49, P 5 .042) and symptom-atic malunions (0/62 vs 9/49, P 5 .001). Complica-tions in the operative group included hardwareremoval in 5 cases and local infections in 3 cases.These were treated with a single repeat operativeprocedure. In a similar study, which has been pre-sented but not published, Smith and colleagues16

performed a prospective randomized trialcomparing primary plate fixation with nonopera-tive care (sling) in 102 patients. This study wasalso complicated by a high rate of patients lostto follow-up, but the investigators found thatopen reduction and plate fixation resulted in unionof all the 30 cases studied, whereas the nonopera-tive group had 12 nonunions in 35 cases (P 5 .001).They concluded that plate fixation was safe,

DASH Results

05101520253035404550

6 12 24 52

Weeks

NonoperativeOperative

Fig. 1. Acute displaced midshaft fractures of the clav-icle. GraphicalanalysisofmeanConstant shoulder scoresin the operative plate fixation group versus nonopera-tive group at 6 weeks, 12 weeks, 24 weeks, and 52 weeksfollow-up. Values are statistically improved for the oper-ative group at each time point (P<.01 for all). (Adaptedfrom COTS study; Canadian Orthopaedic TraumaSociety. Nonoperative treatment compared with platefixation of displaced midshaft clavicle fractures. A multi-center, randomized clinical trial. J Bone Joint Surg Am2007;89:7; with permission.)

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effective, and superior to nonoperative care withregard to preventing nonunion and improvingpatient function. They reported a 30% rate of hard-ware removal. It is important to note that both thesestudies were performed before the availability ofanatomic precontoured plates.

DASH Results

05101520253035404550

6 12 24 52

Weeks

NonoperativeOperative

Fig. 2. Acute displaced midshaft fractures of the clav-icle. Graphical analysis of mean DASH scores in theoperative plate fixation group versus non-operativegroups at 6 weeks, 12 weeks, 24 weeks, and 52 weeksfollow-up. The DASH is a disability score in whichaperfect extremity would typically score 0 (mean valuesfor a normal population are in the 4–8 range). Valuesare worse in the nonoperative group at each timepoint (6 week P<.01, 12 week P 5 .04, 24 week P 5

.05, 52 week P<.01). (Adapted from COTS study; Cana-dian Orthopaedic Trauma Society. Nonoperative treat-ment compared with plate fixation of displacedmidshaft clavicle fractures. A multicenter, randomizedclinical trial. J Bone Joint Surg Am 2007;89:8; withpermission.)

Based on these studies there is evidence thatprimary plate fixation of completely displaced mid-shaft fractures of the clavicle improves patientoutcome and reduces the rate of nonunion andsymptomatic malunion when compared withnonoperative care. This information is used whenmaking a decision with the patient as to theoptimal treatment method for their fracture.

Intramedullary Pin Fixation VersusNonoperative Treatment

A randomized prospective trial performed in a USmilitary population compared nonoperative carewith intramedullary fixation (modified Hagie pin)of displaced clavicle fractures. There was nostatistically or clinically significant difference inshoulder outcome scores at 1 year (operative 93vs nonoperative 98).22 Also, complications weresignificantly higher in the operative group,including nonunion, refracture, infection, and pinprominence. However, the high rate of loss ofreduction in the operative group (47%, leading topin prominence as the fracture site shortened)indicates that fixation was suboptimal. An earlierretrospective study compared nonoperative(figure-of-eight bandage) with operative (intrame-dullary pin fixation) treatment in an Asian civilianpopulation.21 The investigators reported no signif-icant differences in shoulder scores (nonoperative85 vs operative 83) at final review. The operativegroup had several complications including 8 infec-tions, 3 refractures, 2 hardware failures, and 2nonunions (14 of 40 patients, 35%). This techniqueusing an open reduction with a large diameter pindoes not appear to be as consistently successfulas plate fixation. This may be due to several as-yet unclear factors including patient selection(size, compliance), fracture patterns (comminu-tion), or surgery (technique, implant type).

In a randomized trial of 60 patients withcompletely displaced midshaft clavicle fractures,Smekal and colleagues24 compared a differenttype of intramedullary device, a smaller diameterelastic nail, with the nonoperative (sling) treatment.The investigators described a technique in whichthe fracture was reduced and the nail was insertedunder radiographic control in a closed fashion inmost cases. They reported superior outcomes inthe operative group with better DASH andConstant scores at multiple time points up to andincluding 24 months after injury. There were 3nonunions and 2 symptomatic malunions requiringcorrection in the nonoperatively treated groupcompared with no such complication in the grouptreated with a pin. However, there was pin protru-sion in 7 patients and 2 required revision surgery.

Table 1Meta-analysis of nonoperative treatment, intramedullary pinning, and plate fixation for displacedmidshaft fractures of the clavicle (Published 1975–2005)

Treatment Nonunion (%)Infections(%, Total)

Infections(%, Deep)

FixationFailures (%)

Non-operative,N5159

15.1 0 0 0

Plating, n5460 2.2 4.6 2.4 2.2

Intramedullarypinning,n5152

2.0 6.6 0 3.9

Data from Zlowodzki M, Zelle BA, Cole PA, et al. Treatment of mid-shaft clavicle fractures: systemic review of 2144 frac-tures. J Orthop Trauma 2005;19(7):504–8.

Clavicle Fractures in 2010: Sling/Swathe or ORIF? 229

The authors concluded that their operative tech-nique resulted in a decreased delayed andnonunion rate, resulted in a faster return to func-tion, and provided better long-term functionaloutcome compared with nonoperative treatment.

Although intramedullary pin fixation remainspromising, at the present time the results incomparative studies are too inconsistent to make

Table 2Comparative trials of operative versus nonoperativeof the clavicle

Author/Year Design LOE

StudyRecommenda

COTS 2007 RCT A ORIF with plasuperior to(superior DConstant s

Smith et al,2000

RCT A ORIF with plasuperior to

Grassi et al,2001

Retrospective,comparative

B Nonoperativsuperior tointramedunailing

Judd et al,2009

RCT A Sling equal tHagie pin,highercomplicatiopin group

Smekal et al,2009

RCT A Elasticintramedunailing supto sling

Abbreviations: DASH, disabilities of the arm, shoulder, andinternal fixation; RCT, randomized clinical trial.

any definite conclusions about one treatmentover another.

Plate Fixation Versus Intramedullary Nailing

Because no comparative prospective or random-ized study has been published comparing theoutcome of plating with intramedullary nailing of

treatment of displaced midshaft fractures

tions Pros Cons

teslingASH,

cores)

Good design,multicenter,large number ofpatients

More patients innonoperativegroup lost tofollow-up

tesling

Randomizeddesign

Presented, neverpublished in fulldue to poorfollow-up rate

e care

llary

Large study Retrospective,unusually highsurgicalcomplicationrate

o

ns in

Randomizeddesign

Small numbers(57), singlecenter

llaryerior

Good design,randomized

Surgical techniquenew andunproven

hand; LOE, level of evidence; ORIF, open reduction and

Table 3Recommendations for the optimal treatment of displaced midshaft fractures of the clavicle

StatementGrade ofRecommendation References

Young active patients with completely displacedmidshaft fractures of the clavicle will have superiorresults with primary fracture fixation.

B 14,16,24,26

Antero-inferior plating may reduce the risk ofsymptomatic hardware compared with superiorplating.

C 17

There is no difference in outcome between a regularsling and a figure-of-eight bandage whennonoperative treatment is selected.

B 15,25

There is no difference in outcome between plating andintramedullary nailing of displaced midshaft claviclefractures.

I 10,12,14,18–21,23

Factors associated with poor outcome afternonoperative treatment of displaced midshaftclavicle fractures include shortening and increasingfracture comminution.

A 4–7,9,14,16

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displaced clavicular fractures, no specific recom-mendation can be made. Indirect inference canbe made from the fact that 2 separate randomizedtrials show advantages of plate fixation overnonoperative care,16,26 whereas similar studieswith intramedullary nailing as the operative tech-nique are inconsistent.20–22 The theoretical advan-tages of intramedullary nailing (decreased softtissue dissection, reduced hardware prominence,reduced refracture rate) may not outweigh thedifficulties in maintaining length and rotation ofthe fracture (drawbacks of any unlocked intrame-dullary device). The only information currentlyavailable is an unpublished retrospective reviewwith small numbers (17 patients per group), whichsuggested superiority of intramedullary pinningover plate fixation or nonoperative care for dis-placed midshaft clavicle fractures.20

Meta-analyses on Clavicle Fracture Treatment

A meta-analysis of available data from articles onmidshaft clavicle fractures published between1975 and 2005 has been published.14 This meta-analysis contains information regarding all treatedclavicle fractures, but for the purpose of this articledata regarding displaced fractures are specificallyassessed. A nonunion rate of 15.1% was observedafter nonoperative care of such injuries, whereasthe nonunion rate for similar fractures treatedwith plate fixation was 2.2%. The nonunion ratefor fractures treated with intramedullary pinningwas 2%. Therefore, plating a displaced fractureof the clavicle resulted in a decrease in thenonunion rate from 15.1% to 2.2% when

compared with nonoperative treatment; this repre-sents a relative risk reduction of 86%, (95% CI 571%–93%). A meta-analysis performed by theCochrane Database Review examined 3 trialsthat compared a sling with a figure-of-eightbandage2 or low-intensity pulsed ultrasoundversus placebo1 in the treatment of displaced mid-shaft fractures. There were methodological prob-lems with each study, and no significantdifferences in functional or other outcome couldbe shown. The investigators concluded that, atthe present time, there is no evidence to supportthe superiority of one nonoperative techniqueover another (Tables 1–3).25

SUMMARY

The topic of this article is completely displacedmidshaft fractures, which represent a specificsubset of clavicle injuries. Prospective andrandomized studies using thorough and completeassessment measures show that the rate of unsat-isfactory outcome after nonoperative treatment issignificant—a 15% to 20% rate of nonunion anda 20% to 25% rate of symptomatic malunion.Fracture factors that portend a poor outcomeinclude displacement or shortening of more than2 cm and fracture comminution. If nonoperativetreatment is chosen, sling immobilization followedby early range of motion is recommended. Primaryplate fixation of displaced midshaft clavicle frac-tures improves outcome, results in earlier returnto function, and reduces the nonunion and symp-tomatic malunion rate significantly compared

Clavicle Fractures in 2010: Sling/Swathe or ORIF? 231

with nonoperative treatment. Results fromrandomized studies using intramedullary pinningare inconsistent at present, and it remains to bedetermined if the theoretical advantages of thistechnique will translate into clinical practice. Theinformation from these high-quality studies canbe used to decide on the optimal treatmentmethod for each individual patient.

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