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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
Excluded (n = 52)
Not meeting inclusion criteria
(n = 39)
Refused to participate (n = 13)
Randomised (n = 60 clavicle
fractures)
Fig. 1
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).
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).
treatment of clavicular fractures. Hoofwijk and van der This article was primary edited by P. Page and first proof edited by G. Scott.