TRAUMA

 
Plate fixation compared with nonoperative
treatment of displaced midshaft clavicular
fractures: a randomized clinical trial

A. H. Qvist, Aims
M. T. Væsel, Recent studies of nonoperatively treated displaced midshaft clavicular fractures have
C. M. Jensen, shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies
S. L. Jensen have shown superior functional results and higher rates of healing following operative
treatment. The aim of this study was to compare the outcome in these patients after
From Alborg nonoperative management with those treated with fixation.
University Hospital
Farsø, Farsø, Patients and Methods
Denmark In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute
displaced fracture of the midthird of the clavicle were randomized to either nonoperative
treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or
fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a
mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm,
Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of
union. Patients were followed for one year.

Results
A total of 60 patients in the nonoperative group and 64 in the operative group completed
one-year follow-up. At three months’ follow-up, both the median DASH (1.7 vs 8.3) and
median Constant scores (97 vs 90) were significantly better in the operated group (both
p = 0.02). After six months and one year, there was no difference in the median DASH or
Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients,
p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The
plate was subsequently removed in 16 patients (25%). One patient had a new fracture after
removal of the plate and one underwent revision surgery for failure of fixation.

Conclusion
  A. H. Qvist, MD,
Orthopedic Surgeon,
Fixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking
Department of Orthopedics, screws results in faster functional recovery and a higher rate of union compared with
Alborg University Hospital,
Farsø, Denmark.
nonoperative management, but the function of the shoulder is equal after six months and
  M. T. Væsel, MD, Orthopedic at one year.
Surgeon, Department of
Orthopedics, Viborg Regional Cite this article: Bone Joint J 2018;100-B: 1385–91.
Hospital, Viborg, Denmark.
  C. M. Jensen, MD,
Orthopedic Surgeon,
Department of Orthopedics,
Randers Regional Hospital,
Comminuted, displaced midshaft clavicular frac- shoulder and rate of nonunion after nonoperative
Randers, Denmark. tures are common.1-5 Early papers reported a low treatment of a comminuted displaced ­ midshaft
  S. L. Jensen, MD, PhD, incidence of nonunion and high satisfaction fol- clavicular fracture with fixation using a pre-­
Orthopedic Surgeon,
Department of Orthopedics, lowing nonoperative treatment.3,4,6 Accordingly, the contoured plate and locking screws. The null
Alborg University Hospital, routine treatment has been nonoperative, regard- hypothesis was that operative treatment does not
Farsø, Denmark.
less of displacement. Studies of nonoperatively provide better functional outcomes or a reduced
Correspondence should be treated displaced midshaft clavicular fractures, risk of nonunion in these patients.
sent to A. H. Qvist; email:
aqvistchristensen@gmail.com
however, have shown a high incidence of nonun-
ion and unsatisfactory functional outcome,2,7,8 and Patients and Methods
©2018 The British Editorial
Society of Bone & Joint Surgery some have shown superior results with higher rates This Danish multicentre trial was conducted at Aal-
10.1302/0301-620X.100B10. of healing following operative treatment.9,10 borg University Hospital, Viborg Regional H
­ ospital
BJJ-2017-1137.R3 $2.00
Our aim in this multicentre, randomized con- and Randers Regional Hospital, which together
Bone Joint J trolled trial was to compare the function of the serve a population of approximately one million.
2018;100-B:1385–91.

THE BONE & JOINT JOURNAL 1385

1386 A. H. Qvist, M. T. Væsel, C. M. Jensen, S. L. Jensen 
Between February 2010 and May 2014, patients with an acute
displaced midclavicular fracture who were treated in the emer-
gency departments of one of the three hospitals were evaluated
for inclusion in the study. The inclusion criteria were patients
aged between 18 and 60 years with a displaced midclavicular who
provided informed consent. A displaced fracture was defined as a
fracture with no contact between the ends of the bone at the frac-
ture site on at least one of two anteroposterior radiographs with a
15° to 30° angle between them in the sagittal plane. Exclusion cri-
teria were: bilateral fractures, impending perforation of the skin,
open fracture, neurovascular injury, another fracture in the same
limb, pathological fracture, a history of symptoms from the shoul-
der, previous clavicular fracture, more than two weeks since the
injury, cognitive impairment, an inability to follow the protocol of
treatment, and contraindications to general anaesthesia or surgery.
After written informed consent was obtained, patients were
randomized to either nonoperative or operative treatment using
sealed envelopes based on computer-generated randomization,
which was stratified by the surgical centre using blocks of ten
patients. Each block had an equal allocation to nonoperative
and operative treatment. This method of randomization was
chosen to ensure an equal distribution of nonoperatively and
operatively treated patients at the three centres.
Patients in the nonoperative arm of the study were treated with
a sling (Collar’n’Cuff, Mölnlycke Health Care, Sweden) for a
maximum of three weeks. They were encouraged to discontinue
the sling when they no longer felt it was necessary and to use the
arm and shoulder within the limits of pain. No physiotherapy
was instituted. Patients with symptomatic radiological nonunion
six months after the injury were offered surgical treatment, con-
sisting of debridement, reaming of the medullary canals, and fix-
ation with a plate. Bone graft was used from hypertrophic local
bone and from the iliac crest if necessary. This group of patients
was analyzed using the intention-to-treat principle.
Those in the operative arm underwent surgery within 14
days of the injury. The operations were undertaken under gen-
eral anaesthesia accompanied by a single dose of ­intravenous
prophylactic antibiotic by orthopaedic specialists (SLJ, CM,
MTV) using a pre-contoured plate and locking screws (Acumed,
Hillsboro, Oregon). The skin was incised parallel to the bone
and the supraclavicular nerves were identified and preserved if
possible. The plate with the best fit was chosen, so that at least
three bicortical screws could be placed in each main fragment.
The postoperative regimen was identical to that of the non-­
operatively treated patients.
At six months patients with radiological and clinical significant
signs of non-union were offered secondary ­surgical treatment.
This group of patients was a­ nalysed after the i­ntention-to-treat
principle. Patients with symptomatic h­ ardware, whose ­fractures
were united, were offered removal of the plate six months
postoperatively.
Outcome.  Patients were examined clinically and radiograph-
ically after six weeks and after three, six, and 12 months. The
primary outcome was the Disabilities of the Arm, Shoulder and
Hand (DASH) score.11 Secondary outcomes were the Constant
score12 and radiographical evidence of union. Nonunion was
­defined as lack of callus formation, persistent fracture lines,
and/or sclerotic edges of the bones at the fracture site at six
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months. The nonunion was regarded as symptomatic if these
­findings were combined with pain at the fracture site, ­tenderness
and ­local crepitation. The Constant score was r­ecorded by a
­specialist nurse; the patients were encouraged not to tell which
treatment they had received, and both shoulders were covered
by clothes.
Statistical analysis. The sample size was calculated on the ba-
sis of a power (1 - β) of 80%, a risk of type I error (α) of 5%
and a standard deviation of 20 points for the DASH score. A
total of 63 patients were required in each group to d­ emonstrate
a clinically relevant ten-point difference in DASH score13 at 12
months. In order to allow for loss to follow-up, the recruitment
was increased to 150 patients in total. All statistical analysis was
conducted using Stata (version 13.1, Stata Corp, College Station,
Texas). Continuous variables were analyzed using ­Student’s
t-test for normally distributed data and M ­ ann–­Whitney U test
for non-Gaussian distributed data. Categorical variables were
tested using chi-squared test or Fisher’s exact test if one value
was five or less. A number-needed-to-treat (NNT) analysis was
performed to evaluate the effectiveness of surgery in order to
avoid nonunion. The level of significance was set at p < 0.05.
Results
A total of 150 patients were enrolled and 75 randomized to each
group. Four patients randomized to the nonoperative group
withdrew consent after randomization and were excluded.
One in the operative treatment group who declined surgery
was followed in this group according to the intention-to-treat
principle.14,15
A total of 22 patients, 11 in each group, were lost to ­follow-up.
All the data before the time of loss to follow-up were included
in the analysis. A total of 60 patients (85%) in the nonoperative
group and 65 (85%) in the operative group completed one-year
follow-up (Fig. 1).
The detailed demographics and the morphology of the
­fracture are shown in Table I.
Functional outcome. At six weeks’ and three months’
­follow-up, the mean DASH (p  <  0.001 and p  =  0.02, respec-
tively; Mann–Whitney U test) and Constant (p  <  0.001 and
p  =  0.02, respectively; Mann–Whitney U test) scores were
­significantly better in the operated group (p < 0.05). There was,
however, no significant difference thereafter (Figs 2 and 3).
Union of the fracture. A total of 11 patients (17%, 95% confi-
dence interval (CI) 9.1 to 29.1) in the nonoperative group devel-
oped nonunion. One was asymptomatic; ten were ­symptomatic
and nine of these were treated with open reduction and plate
­fixation. One patient, with an aortic aneurysm, did not ­undergo
surgical treatment for nonunion. All surgically treated ­nonunions
had united one year after inclusion in the study.
Two patients (3%, 95% CI 0.0 to 7.1) in the operative group
developed a nonunion. The first had initial fixation using only
two screws in each main fragment, rather than three, as required
in the protocol. Accordingly, revision surgery was undertaken
and union obtained. The other nonunion was in the patient who
declined operation after randomization, and the nonunion thus
should not be regarded as a failure following fixation. Both
patients continued in the operative treatment group according
to the intention-to-treat principle.14,15
THE BONE & JOINT JOURNAL
 PLATE FIXATION COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES 1387

Assessed for eligibility (n = 167)

Excluded (n = 17)
Enrolment

– Not meeting inclusion criteria (n = 8)

– Declined to participate (n = 9)

Randomized (n = 150)

Allocated to operative treatment (n = 75)

Allocated to nonoperative treatment (n = 75)
Allocation

– Received allocated intervention (n = 74)

– Received allocated intervention (n = 71)
– Did not receive allocated intervention
– Withdrew consent (n = 4)
(n = 1) (opted for nonoperative treatment)

Total lost to follow-up (n = 11) Total lost to follow-up (n = 11)

Follow-up

– At 6 weeks (n = 6) – At 6 weeks (n = 5)
– At 3 months (n = 2) – At 3 months (n = 2)
– At 6 months (n = 2) – At 6 months (n = 1)
– At 1 year (n = 1) – At 1 year (n = 3)
Analysis

Analyzed (n = 64) Analyzed (n = 60)

Fig. 1

Study flow diagram.

Table I. Demographic data and fracture morphology

Parameter Nonoperative treatment (n = 71) Operative treatment (n = 75)

Mean age, yrs (range) 39 (18 to 60) 40 (18 to 60)
Age, 18 to 30 yrs vs 31 to 45 yrs vs 46 to 60 yrs, n 19:30:22 19:29:27
Male vs female, n 55:16 64:11
Smoker:non-smoker, n 16:53 (N/A: 2) 18:54 (N/A: 3)
Shoulder straining work, % 51 42
Fracture at dominant arm, yes:no, n 29:39 (N/A: 3) 30:44 (N/A: 1)
Non-comminuted:comminuted fracture, n 20:48 (N/A: 3) 26:46 (N/A: 3)
Shortening category ratio, < 1 cm:1 cm to 2 cm:> 2 cm, n 20:32:16 (N/A: 3) 18:32:21

The rate of nonunion was significantly lower in the oper-
ated group (p = 0.009, Fisher’s exact test). The relative risk of
developing a nonunion after nonoperative treatment compared
with operative treatment was 5.7 (95% CI 1.3 to 24.6; p = 0.02),
and the number-needed-to-treat (NNT) operatively in order to
prevent one nonunion was seven. A per-protocol analysis low-
ered the rate of nonunion following surgery to 1.5% (95% CI
0.0 to 4.5) and raised this rate following nonoperative treatment
to 18.8% (95% CI 10.1 to 30.4). The NNT calculated using
per-protocol analysis was six.

VOL. 100-B, No. 10, OCTOBER 2018

1388 A. H. Qvist, M. T. Væsel, C. M. Jensen, S. L. Jensen 

45 Nonoperative treatment
Operative treatment
40
35
30
25
DASH

20
15
10
5
0
6 wks 3 mths 6 mths 1 yr
Follow-up

Fig. 2

Bar chart showing median Disabilities of the Arm, Shoulder and Hand (DASH) scores during one year of
follow-up. At six weeks’ and three months’ follow-up, median scores were significantly better in the oper-
ated group (p < 0.001 and p = 0.02, respectively; Mann–Whitney U test). After six months and at one year,
there was no difference between the groups. Error bars indicate interquartile ranges.

Nonoperative treatment
Operative treatment

100
90
80
70
Constant score

60
50
40
30
20
10
0
6 wks 3 mths 6 mths 1 yr
Follow-up

Fig. 3

Bar chart showing median Constant scores. At six weeks’ and three months’ fol-
low-up, the median scores were significantly better in the operated group (p < 0.001
and p = 0.02, respectively; Mann–Whitney U test). After six months and at one year,
there was no significant difference between the groups. Error bars indicate interquar-
tile ranges.

The mean DASH scores in the nonoperative group were
s­ ignificantly worse at six months follow-up for those with non-
union compared with those whose fractures united (15.8 vs 2.5,
p = 0.02, Mann–Whitney U test). There was no ­significant differ-
ence in the nonoperative group between patients with nonunion
and those with union in regard to age, gender, smoking status,
and the comminution or displacement of the fracture (Table II).
Adverse events and complications. A total of 16 patients
(25%) in the operative group had the plate removed after six
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months without complications. One patient had a new ­fracture
four months after removal of the plate. This was medial to
the original fracture, independent of previous screw holes,
and healed after nonoperative treatment. One patient who had
­failure of fixation with screws pulling out ­medially four months
postoperatively underwent revision with debridement and
­further fixation. There were no clinical signs of infection, but
perioperative cultures showed Propionibacterium. The fracture
united after eight weeks of antibiotic treatment.
THE BONE & JOINT JOURNAL
 PLATE FIXATION COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES
Table II. Demographics and morphology of the fracture in the nonoperative group
Parameter
Mean age, yrs (range)
Male vs female, n
Smoker vs non-smoker, n
Comminution vs no Comminution, n
Shortening more than 2 cm vs less than 2 cm, n
*
Student’s t-test
†
Chi-squared test, or Fisher’s exact test if one value was five or less
At one year, 13 patients (21%) in the nonoperative group and
44 (70%) in the operative group complained of dysaesthesia
around and below the fracture site.
Discussion
In this randomized study, we found that operating on patients
with a displaced midclavicular fracture reduced the risk of devel-
oping nonunion. In the nonoperative group, 11 patients (17%)
developed nonunion, which is comparable with previously
reported rates.2,9,10,16-19 Previous randomized studies have shown
that fixation with a plate reduces the risk of nonunion by a sim-
ilar factor.9,10,16-19 In the operative group, only two patients (3%)
developed nonunion. Although one of these decided against sur-
gical treatment, the patient remained in the operative treatment
group in accordance with the intention-to-treat principle.15
The NNT with primary plate fixation in order to prevent one
nonunion was seven. For some patients, such a number may
appear high considering that a symptomatic nonunion may
be treated successfully. There is also a risk of neurovascular
complications,20 although surgery for a clavicular fracture
generally has a low complication rate.9,10,16-19 Some patients
may, however, be willing to expose themselves to the risks of
surgery in order to have a quicker recovery and reduce the 1:6
risk of nonunion. In our series, all nine nonunions treated by
debridement, plate fixation, and bone grafting healed. A rate
of healing of more than 90% may be expected following the
surgical treatment of mid-clavicular nonunions.21 It may be
possible to reduce the NNT by only operating on those with
a high risk of nonunion following nonoperative treatment.
We found two statistical models that estimate the risk of non-
union.22,23 These are based on the comminution and displace-
ment of the fracture combined with either age and gender23
or smoking status.22 Based on these parameters, each model
gives a probability of nonunion at 24 weeks. These models
have not been externally validated. In a newer study, Clement
et al24 found that smoking and a DASH score of > 35 points at
six weeks following fracture was associated with a high risk
of nonunion. We suggest further investigation of the possible
benefits of surgery in which only patients at a high risk of
nonunion are treated.
One patient in this study developed a deep infection, which
resolved after debridement and antibiotic treatment. Including
the need for removal of hardware, which was considered in this
study to be a complication, 17 patients in the operative group
had further surgery due to complications.
Although the branches of the supraclavicular nerve were
protected at the time of surgery, many patients in the operative
VOL. 100-B, No. 10, OCTOBER 2018
1389
Union (n = 52) Nonunion (n = 11) p-value
37 (27 to 50) 41 (36 to 53) 0.11*
40:12 8:3 0.71†
9:43 5:6 0.05†
36:16 7:4 0.74†
12:40 3:8 0.71†
group developed dysaesthesia. Avoiding injury to this nerve,
however, can be difficult, as the distribution of its branches
varies widely.25 Interestingly, some patients in the nonoperative
group also developed dysaesthesia. This may have been due to
nerve injury at the time of the initial fracture, or callus forma-
tion. Patients were initially examined for neurovascular injury
affecting the arm, but not for local dysaesthesia. For patients
with a simple uncomminuted fracture, it may be possible to
further reduce the risk of complications by using elastic stable
intramedullary nailing (ESIN) instead of plating.26 The use of
ESIN shows no other advantages compared with plating.27
We found early improvements in functional outcome for
patients in the operative group, in whom both DASH and Con-
stant scores improved faster with higher scores at six weeks and
three months. This difference was not subsequently maintained,
and there were no differences in functional outcome at six and
12 months. Similar findings were reported in a Canadian mul-
ticentre study.10 Robinson et al9 also reported improved func-
tional outcomes in patients treated operatively at three months
and one year, but no difference in the Constant score at six
weeks and six months. Ahrens et al18 more recently also found
early improvements in functional outcome for surgically treated
patients at six weeks and three months, but no difference at nine
months. Woltz et al19 and Virtanen et al16 found no difference in
functional outcome at any timepoints. In a recent meta-analysis,
Woltz at al28 found a mean difference of 5.1 points in DASH
score favouring operative treatment, at 12 months’ follow-up.
This difference is not, however, clinically relevant,13 and Woltz
et al28 concluded that there is not enough evidence to support
routine operative treatment. In the Canadian study,10 nonunions
in the nonoperative group were not treated, but were included
in the analysis. We found that patients with a nonunion had a
poorer functional outcome compared with those whose frac-
tures united, and therefore including untreated nonunions may
affect the outcome. Accordingly, Robinson et al9 showed no sig-
nificant difference in DASH or Constant score at any timepoint
after excluding patients with nonunion.
The rate of loss to follow-up in this study was 15%, and
similar in both groups. In the worst-case scenario, symptomatic
patients in the nonoperative group drop out to seek surgery
elsewhere, and patients in the operative group drop out because
the outcome is good and they no longer feel the need to be
reviewed. Such a scenario may give an overestimation of the
functional outcome in the nonoperative group and underesti-
mation in the operative group. Since patients were routinely
presented with the option of removal of the plate as a part
of the study, there is a risk that this need is overemphasized.
1390 A. H. Qvist, M. T. Væsel, C. M. Jensen, S. L. Jensen 
Likewise, the nonunions may have been overtreated, and we do
not know if symptoms of nonunion may diminish over time and
make these patients less likely to seek further attention.
As in multicentre studies, there was a risk of straying from
the protocol. The surgical protocol was not adhered to in one
patient with failure of fixation and nonunion. If the prescribed
technique had been used, it is possible that the fracture would
have healed unremarkably, resulting in a lower rate of nonunion
in the operative group.
The statistical analysis does not account for potential bias as
a result of a clustering effect by clinic. The risk of clustering in
this study is believed to be low, as all surgeons had the same
level of experience, the number of clinics was low, and data
from each clinic included both treatment options.
In the nonoperative group, only 60 patients were available
for analysis at follow-up of one year. Our sample size calcula-
tion required 63 patients in each group to demonstrate a clini-
cally relevant ten-point difference in DASH score. There is thus
a risk of type 2 error in the analysis of DASH scores at one-year
follow-up.
In our sample size calculation, we assumed a standard
deviation of 20 points. This assumption may be too high, as
randomized controlled trials completed after our sample size
calculation report a lower standard deviation in DASH score
at one-year follow-up.9,16,19 The highest standard deviation in
these trials was 13.5, as reported by Virtanen et al.16 Assum-
ing the width of the interquartile range of the 12-month DASH
score in our study to be 1.35 times the standard deviation,29 the
standard deviation in our study would be 7.9 points. Using a
standard deviation of 13.5 points as a worst-case scenario, a
new sample size calculation would require only 29 patients in
each group. We believe that our initial calculation overestimates
the required number of patients and we estimate the risk of type
2 error due to lack of power to be low.
In conclusion, fixation of a displaced midshaft clavicular frac-
ture with a pre-contoured plate and locking screws results in a
higher rate of union and faster functional recovery compared
with nonoperative treatment, but there is no difference in func-
tion after six months and one year. Fixation effectively reduces
the risk of nonunion, and routinely operating all these fractures
means that seven patients need surgical treatment to avoid one
nonunion. We suggest that further studies should be undertaken
to identify patients at high risk of developing a nonunion.
Take home message
- Osteosynthesis of displaced midshaft clavicular fractures
results in higher union rates and faster functional recovery
compared with nonoperative treatment.
- There is no long-term difference in functional outcome.
- Osteosynthesis effectively reduces the risk of nonunion with a number-
needed-to-treat (NNT) of seven.
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 PLATE FIXATION COMPARED WITH NONOPERATIVE TREATMENT OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES 1391

Author contributions: Although none of the authors has received or will receive benefits for personal
A. H. Qvist: Acquiring and analyzing the data, Drafting and approving the or professional use from a commercial party related directly or indirectly to
manuscript. the subject of this article, benefits have been or will be received but will
M. T. Væsel: Acquiring the data, Revising and approving the manuscript. be directed solely to a research fund, foundation, educational institution,
C. M. Jensen: Designing the study, Acquiring the data, Revising and approving or other non-profit organization with which one or more of the authors are
the manuscript. associated.
S. L. Jensen: Designing the study, Acquiring and analyzing the data, Revising
and approving the manuscript. Acknowledgements
The authors would like to acknowledge Ulla Hornum and Andrea Søe-Larsen for
Funding statement:
their contribution to this study.
This study received funding from Swemac Orthopaedics Aps.ClinicalTrials.gov
Identifier: NCT01078480. This article was primary edited by J. Scott.

VOL. 100-B, No. 10, OCTOBER 2018