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TRAUMA

Comparison of simple arm sling and figure of


eight clavicular bandage for midshaft
clavicular fractures
A RANDOMISED CONTROLLED STUDY
A. Ersen, Only a few randomised, controlled studies have compared different non-operative methods
A. C. Atalar, of treatment of mid-shaft fractures of the clavicle.
F. Birisik, In this prospective, randomised controlled study of 60 participants (mean age 31.6 years;
Y. Saglam, 15 to 75) we compared the broad arm sling with the figure of eight bandage for the
M. Demirhan treatment of mid-shaft clavicle fractures. Our outcome measures were pain, Constant and
American Shoulder and Elbow Surgeons scores and radiological union.
From Istanbul The mean visual analogue scale (VAS) pain score on the first day after treatment was
University Istanbul significantly higher (VAS 1 6.8; 4 to 9) in the figure of eight bandage group than the broad
Medical Faculty, arm sling group (VAS 1 5.6; 3 to 8, p = 0.034). A mean shortening of 9 mm (3 to 17) was
Istanbul, Turkey measured in the figure of eight bandage group, versus 7.5 mm (0 to 24) in the broad arm
sling group (p = 0.30).
The application of the figure of eight bandage is more difficult than of the broad arm
sling, and patients experience more pain during the first day when treated with this option.
We suggest the broad arm sling is preferable because of the reduction of early pain and ease
of application.
Cite this article: Bone Joint J 2015;97-B:15625.

Fractures of the clavicle are common, account- with the primary outcome measures of pain
ing for approximately 2.5% of all fractures and radiological shortening and secondary
presenting to orthopaedic surgeons and occur- measures of radiological union and functional
ring most commonly in young males.1 status, with the hypothesis that the figure of
Although the proportion managed operatively eight demonstrated inferiority.
A. Ersen, MD, Orthopaedic
Surgeon,
has increased in recent years, the majority
A. C. Atalar, MD, Orthopaedic (80%) occur at the mid-shaft and are treated Patients and Methods
Surgeon, Associate Professor,
F. Birisik, MD, Orthopaedic
non-operatively.2 The rate of nonunion for Between August 2012 and September 2013, 60
Surgeon, completely displaced mid-shaft fractures has eligible patients with a mean age of 31.6 years
Y. Saglam, MD, Orthopaedic
Surgeon,
recently been reported to be 15.1% in a meta- (15 to 75) were randomised to conservative
Department of Orthopaedics analysis of 2144 fractures treated non-opera- treatment with either a broad arm sling or a
and Traumatology
Istanbul University Istanbul
tively.2 A number of studies have compared figure of eight bandage. Patient counselling
Medical Faculty, Capa, Istanbul, operative and non-operative treatment for dis- and informed consent was carried out by two
Turkey.
placed mid-shaft clavicle fractures, most authors (AE, FB). We employed non-stratified
M. Demirhan, MD, reporting better functional results with open randomisation in blocks of two using the
Orthopaedic Surgeon,
Professor, Department of reduction and internal fixation with a plate sealed envelope method, so when one patient
Orthopaedics and and screws.3-6 While this may become the ref- had chosen an envelope, the next patient
Traumatology
KOC University School of erence standard for treatment for completely would be allocated to a group according to the
Medicine, Istanbul, Turkey. displaced mid-shaft fractures, there remains a remaining envelope of the pair. The protocol
Correspondence should be sent role for non-operative treatment. Non- was approved by our institutional review
to Dr A. C. Atalar; e-mail:
atalar.ac@gmail.com
operative methods ranging from a spica cast to board.
benign neglect.7 The figure of eight bandage Patients meeting our inclusion criteria were
2015 The British Editorial
Society of Bone & Joint and the broad arm sling are most commonly those over the age of 15 years who sustained
Surgery used and, despite their wide use, very few ran- an isolated, mid-shaft clavicular fracture and
doi:10.1302/0301-620X.97B11.
35588 $2.00 domised studies have compared the two.8,9 presented on the day of injury. Those under 15
Our experience has been that patients appear years of age, with fractures of other parts of
Bone Joint J
2015;97-B:15625. less comfortable when the figure of eight band- the clavicle, open injuries or pathological frac-
Received 22 December 2014; age is used and so we set out to compare the tures, involvement in polytrauma or presenta-
Accepted after revision 10 July
2015 two methods in the first 14 days of treatment tion delayed beyond 24 hours post-injury were

1562 THE BONE & JOINT JOURNAL


COMPARISON OF SIMPLE ARM SLING AND FIGURE OF EIGHT CLAVICULAR BANDAGE FOR MIDSHAFT CLAVICULAR FRACTURES 1563

Assessed for eligibility (n = 112


clavicle fractures)

Excluded (n = 52)
Not meeting inclusion criteria
(n = 39)
Refused to participate (n = 13)

Randomised (n = 60 clavicle
fractures)

Allocated to simple arm sling Allocated to figure of 8 bandage


(n = 30 received intervention (n = 30) (n = 30 received intervention (n = 30)

Lost to follow-up (n = 3 unable to


Lost to follow-up (n = 1,
come to the hospital)
unable to come to the
Discontinued intervention (n = 3
hospital)
declined to continue)
Discontinued intervention
Excluded from the study (n = 1,
(n = 1, declined to continue)
not followed the study protocol)

Analysed (n = 28) Analysed (n = 23)

Fig. 1

Flow diagram of recruitment to the study.

excluded. The only analgesia permitted was paracetamol the comparison of two means method. For the broad arm
and those who could not comply and required further anal- sling and figure of eight bandage groups the mean VAS and
gesia were also excluded. standard deviations (SD) on day one were 5.00 (SD 2.31) and
The upper limb was immobilised in internal rotation 7.00 (SD 1.63), respectively. On day seven, the values were
with the relevant sling for three weeks. Patients and rela- 2.50 (SD 1.12) and 2.33 (SD 2.05). This produced a sample size
tives of those in the figure of eight bandage were educated of 44 to identify a significant difference.
on how to tighten the bandage when it loosened. The Statistical analysis. The primary outcomes were VAS at days
patients were free to use their arms with the figure of eight one, three, seven and 14 and the confirmation of mean union
bandage and those in a broad arm sling were advised to flex at the end of the treatment. Secondary outcomes were Con-
and extend their elbows three times a day for ten minutes. stant and ASES scores. All continuous data were compared
Patients re-attended to complete the outcome measures using two-sample paired Student's t-tests with significance set
the next day (day one), and on days three, seven, 14 and 21. at a p-value of < 0.05. For the comparison of categorical vari-
The pain was recorded on a visual analogue scale (VAS) able (patient satisfaction) the chi-squared test was used. All
from 1 to 10 (best to worst). Ongoing consent to participa- analyses were performed with the MedCalc B-8400 statistical
tion was ascertained at each visit. analysis software package (MedCalc, Ostend, Belgium).
Anteroposterior (AP) radiographs were obtained and
assessed by two authors (AE, FB) at weeks four, eight and Results
12 and the time to union (appearing of the bone bridging) Of the 60 patients initially enrolled, we excluded four
recorded. Mean follow-up was 8.2 months (6 to 12). At the patients who declined to continue participation, four who
end of the treatment, the length of both clavicles (fractured were unable to come to the hospital for evaluation in the
and uninjured contralateral) on AP radiographs was meas- first two weeks and one who took different painkillers
ured and the degree of shortening was calculated. Constant (Fig. 1). Of the remaining 51 patients, 28 were treated with
and American Shoulder and Elbow Surgeons10,11 scores broad arm slings, and 23 with figure of eight bandages. The
were used for functional evaluation at the last follow-up. two groups were similar in terms of age, gender distribu-
Sample size calculation. After enrolment of five patients to tion, and proportion with their dominant hand affected
both groups, a sample size calculation was carried out using (Table I).

VOL. 97-B, No. 11, NOVEMBER 2015


1564 A. ERSEN, A. C. ATALAR, F. BIRISIK, Y. SAGLAM, M. DEMIRHAN

Table I. Demographic details of the two treatment groups

Broad arm sling Figure of eight bandage


Patients 23 28
Mean age (yrs) (range) 28.7 (15 to 72) 33.5 (16 to 75)
Gender distribution (male/female) 19/4 22/6
Arm (dominant/non-dominant) 13/10 15/13
Fracture displacement
Displaced/not displaced 15/8 18/10

Table II. Visual analoge scale (VAS) for pain changes during the first three weeks of the treatment. Data are presented as
means with standard deviation (SD)

VAS for pain (0 to 10) Broad arm sling group (n = 23) Figure of eight bandage group (n = 28) p-value
Day 1 5.5 (SD 1.8) 6.8 (SD 1.7) 0.034
Day 3 5.6 (SD 1.85) 6.8 (SD 1.7) 0.06
Day 7 2.0 (SD 2.1) 1.9 (SD 1.5) 0.9
Day 14 0.9 (SD 0.8) 0.9 (SD 1.4) 0.8
Day 21 0.5 (SD 0.3) 0.6 (SD 0.7) 0.9

Fig. 2 Fig. 3

Radiograph of the measurement of the clavicular length for a fracture of Radiograph of the measurement of the clavicular length for a fracture
the left clavicle treated with a figure of eight bandage. of the right clavicle treated with a broad arm sling.

The mean VAS on the first day after treatment was sig- in rate of expression of dissatisfaction was not different
nificantly lower (p = 0.034, 95% confidence interval (CI) between the two groups (p = 0.6, chi-squared test).
0.10 to 2.46) in the broad arm sling group at 5.5 (SD 1.8) Healing time and return to work/school. In total 48 (95%)
than in the figure of eight group at 6.8 (SD 1.7). The mean fractures had united in eight weeks, and the remaining three
VAS on days three, seven, 14 and 21 were statistically sim- had united by 14 weeks post-injury. Patients in the broad
ilar (p = 0.06, 95% CI 0.05 to 2.34; p = 0.9, 95% CI -1.34 arm sling returned to work or school in a mean of 4.6
to 1.2; p = 0.8, 95% CI -0.63 to 0.52; p = 0.9, 95% CI -0.6 weeks (3 to 9), compared with those in the figure of eight
to 0.7, respectively). In both groups pain was almost group who required 4.3 weeks (3 to 8) (p = 0.19).
resolved on day 14, with a decrease in the mean VAS to 1 or Radiological shortening. The mean shortenings in the figure
below (Table II). of eight bandage and broad arm sling groups were 9 mm
Patient satisfaction. A total of five (18%) of the 28 patients (SD 3.8) and 7.7 mm (SD 3.0), respectively (p = 0.30; 95%
in the figure of eight group were dissatisfied with the treat- CI -2.2 to 5.3, Figs 2 and 3). The maximum shortening was
ment method; two had swelling of the injured extremity on 24 mm in a patient in the broad arm sling group.
day one, which resolved after loosening of the bandage. Functional evaluation. After a mean follow-up of 8.3
Three (10%) further patients had some abrasion of axillary months (6 to 12), patients in both treatment groups
skin by day seven because of the friction and compression achieved high Constant and ASES scores. The mean Con-
from the bandage. stant scores were 96 (80 to 100) in the figure of eight group
In contrast, three (12%) of the 25 patients comprising and 96.75 (75 to 100) in the broad arm sling groups
the broad arm sling group were dissatisfied because of (p = 0.676) and mean ASES scores were 94.5 (82 to 100)
mobility and crepitation of the fracture site. The difference and 96.15 (73.3 to 100), respectively (p = 0.873).

THE BONE & JOINT JOURNAL


COMPARISON OF SIMPLE ARM SLING AND FIGURE OF EIGHT CLAVICULAR BANDAGE FOR MIDSHAFT CLAVICULAR FRACTURES 1565

Discussion would offer both greater accuracy in assessment of shorten-


The aim of treatment of clavicular fractures is to restore ing and an ability to evaluate sagittal plane deformities.
shoulder function by allowing the clavicle to heal without In conclusion, both methods provided satisfactory func-
deformity or significant shortening. With non-surgical tional and radiological results for the treatment of mid-
methods, lower than 1% nonunion rates are reported in the shaft clavicle fractures. Although no difference in discom-
literature.12,13 In our study, 51 patients completed the treat- fort was seen at the end of the treatment period, the broad
ment period, all fractures healed successfully and no cases arm sling was significantly more comfortable in the first
of nonunion were observed. One possible reason for this three days and, while no longer significantly different,
result is the small number of patients included in the study, lower mean pain scores persisted throughout the first two
albeit this sample size was informed by an interim power weeks. We therefore suggest the broad arm sling offers sim-
calculation. A high rate of union could also be anticipated ilar functional outcomes and rates of union while providing
in a sample comprising a high proportion (19/51, 40%) of greater pain relief and hence advocate its use in mid-shaft
non-displaced and minimally displaced fractures. The even fractures of the clavicle.
distribution of these patients between the groups should Author contributions:
not have caused any skewing of results. A. E. Ersen: Study design, writing of paper, data collection.
A. C. A. Atalar: Study design, writing of paper.
Studies by Andersen et al8 and Hoofwijk and van der F. B. Birisik: Data collection, data analysis.Y. S. Saglam: Data analysis.
Werken9 were randomised controlled, single-centre studies M. D. Demirhan: Senior author, revision of paper.
(61 and 152 patients, respectively) comparing the broad No benefits in any form have been received or will be received from a commer-
arm sling and figure of eight bandage for the conservative cial party related directly or indirectly to the subject of this article.

treatment of clavicular fractures. Hoofwijk and van der This article was primary edited by P. Page and first proof edited by G. Scott.

Weaken9 reported a statistically significant difference in


favour of the broad arm sling in terms of pain after 15 days References
(mean difference 0.80, 95% CI 0.34 to 1.26). Our early 1. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third frac-
tures of the clavicle gives poor results. J Bone Joint Surg [Br] 1997;79-B:537539.
findings echoed this but, by day three, the differences
2. Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based
became statistically insignificant. Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle frac-
Andersen et al8 found that patient satisfaction following tures: systematic review of 2144 fractures: on behalf of the Evidence-Based Ortho-
paedic Trauma Working Group. J Orthop Trauma 2005;19:504507.
treatment with the figure of eight bandage was lower than 3. Canadian Orthopaedic Trauma S. Nonoperative treatment compared with plate
for patients treated with the broad arm sling (9/34 vs 2/27). fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical
In our study, the rates of dissatisfaction were similar in both trial. J Bone Joint Surg [Am] 2007;89-A:110.
4. Duan X, Zhong G, Cen S, Huang F, Xiang Z. Plating versus intramedullary pin or
groups but the reasons for dissatisfaction were different. To conservative treatment for midshaft fracture of clavicle: a meta-analysis of rand-
avoid irritation of the skin in the axillary area associated omized controlled trials. J Shoulder Elbow Surg 2011;20:10081015.
with the use of the figure of eight bandage, we advocate 5. Kulshrestha V, Roy T, Audige L. Operative versus nonoperative management of
displaced midshaft clavicle fractures: a prospective cohort study. J Orthop Trauma
some form of padding. 2011;25:3138.
It has been reported that clavicular shortening > 15 mm 6. Robinson CM, Goudie EB, Murray IR, et al. Open reduction and plate fixation ver-
may lead to chronic shoulder pain and discomfort.14,15 Ras- sus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter,
randomized, controlled trial. J Bone Joint Surg [Am] 2013;95-A:15761584.
mussen et al16 retrospectively compared the figure of eight 7. Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg 2007;15:239
bandage and broad arm sling in terms of shortening and 248.
found no difference between the two but did note that 8. Andersen K, Jensen PO, Lauritzen J. Treatment of clavicular fractures. Figure-of-
eight bandage versus a simple sling. Acta Orthop Scand 1987;58:7174.
shortening > 20 mm was correlated with poorer outcomes.
9. Hoofwijk AG, van der Werken C. Conservative treatment of clavicular fractures. Z
In this study, the mean shortening was < 15 mm in both Unfallchir Versicherungsmed Berufskr 1988;81:151156.
treatment groups, at 9 mm (SD 3, p = 0.8; figure of eight) 10. Constant CR, Murley AH. A clinical method of functional assessment of the shoul-
and 7.7 mm (SD 3.0; broad arm sling). Six patients from the der. Clin Orthop Relat Res 1987;214:160164.
broad arm sling group and five from the figure of eight 11. Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment
of shoulder function. J Shoulder Elbow Surg 1994;3:347352.
group had > 15 mm shortening but this was not associated 12. Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop
with lower functional results. Relat Res 1968;58:2942.
The randomisation method is another limitation of the 13. Neer CS II. Nonunion of the clavicle. J Am Med Assoc 1960;172:10061011.
study. Complete, software randomisation would offer bet- 14. Eskola A, Vainionpaa S, Myllynen P, et al. Outcome of clavicular fracture in 89
patients. Archives of orthopaedic and traumatic surgery. Arch Orthop Unfallchir
ter statistical validity but lacked practicality in terms of 1986;105:337338.
ensuring equally sized groups in this study. 15. Lazarides S, Zafiropoulos G. Conservative treatment of fractures at the middle
In addition we acknowledge that while it is possible to third of the clavicle: the relevance of shortening and clinical outcome. J Shoulder
Elbow Surg 2006;15:191194.
measure the length of the clavicle with an AP radiograph, it 16. Rasmussen JV, Jensen SL, Petersen JB, et al. A retrospective study of the asso-
is not possible to detect deformities in the sagittal plane. CT ciation between shortening of the clavicle after fracture and the clinical outcome in
136 patients. Injury 2011;42:414417.

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