Download Report

613
C OPYRIGHT Ó 2015
BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Operative Treatment of Dislocated
Midshaft Clavicular Fractures: Plate
or Intramedullary Nail Fixation?
A Randomized Controlled Trial
Olivier A. van der Meijden, MD, PhD, R. Marijn Houwert, MD, PhD, Martijn Hulsmans, MD,
Frans-Jasper G. Wijdicks, MD, PhD, Marcel G.W. Dijkgraaf, PhD, Sven A.G. Meylaerts, MD, PhD,
Eric R. Hammacher, MD, PhD, Michiel H.J. Verhofstad, MD, PhD, and Egbert J.M.M. Verleisdonk, MD, PhD
Investigation performed at the Diakonessenhuis, Utrecht; Academic Medical Center, Amsterdam; Medical Center Haaglanden, The Hague;
St. Antonius Hospital, Nieuwegein; St. Elisabeth Hospital, Tilburg; and Erasmus Medical Center, Rotterdam, the Netherlands
Background: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased.
The aim of this study was to compare short and midterm results of open reduction and plate ﬁxation with those of
intramedullary nailing for displaced midshaft clavicular fractures.
Methods: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120
patients, eighteen to sixty-ﬁve years of age, treated with either open reduction and plate ﬁxation (n = 58) or intramedullary
nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one
year postoperatively. Signiﬁcance was set at p < 0.05.
Results: No signiﬁcant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score
(3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical
interventions at six months postoperatively. Until six months after the surgery, the plate-ﬁxation group experienced less
disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02).
The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-ﬁxation
(0.67) and nailing (0.74) groups (p = 0.65).
Conclusions: The patients in the plate-ﬁxation group recovered faster than the patients in the intramedullary nailing
group, but the groups had similar results at six months postoperatively and the time of ﬁnal follow-up. The rate of
complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be
treated by implant removal.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed
by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a ﬁnal review by the Editor-in-Chief prior to publication.
Final corrections and clariﬁcations occurred during one or more exchanges between the author(s) and copyeditors.
O
ver the past decades, there has been a shift toward the
operative treatment of displaced midshaft clavicular
fractures. The rationale for operative ﬁxation includes
reported higher nonunion rates and increased functional deﬁcits
following nonoperative treatment of displaced midshaft clavicular fractures1-5. Two of the most commonly used techniques for
Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in
support of an aspect of this work. None of the authors, or their institution(s), have had any ﬁnancial relationship, in the thirty-six months prior to submission of
this work, with any entity in the biomedical arena that could be perceived to inﬂuence or have the potential to inﬂuence what is written in this work. Also, no
author has had any other relationships, or has engaged in any other activities, that could be perceived to inﬂuence or have the potential to inﬂuence what
is written in this work. The complete Disclosures of Potential Conﬂicts of Interest submitted by authors are always provided with the online version
of the article.
J Bone Joint Surg Am. 2015;97:613-9
d
http://dx.doi.org/10.2106/JBJS.N.00449
614
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
operative treatment are (1) open reduction and internal plate
ﬁxation and (2) intramedullary nailing6. The optimal ﬁxation
method for these types of fractures remains a topic of debate.
A plate provides immediate rigid ﬁxation, including rotational stability, which is favorable for early rehabilitation protocols and may be technically less demanding7,8. Intramedullary
ﬁxation is in general less invasive, good cosmetic results have been
reported, and the implant is less prominent4. Despite proposed
beneﬁts, each technique has its drawbacks. Infection, hypertrophic scarring, and irritation by and even failure of the implants
have been reported following plate ﬁxation9. Intramedullary nails
often require routine removal to prevent them from migrating
and, prior to this, they may cause irritation10.
The purpose of this multicenter, randomized controlled
trial was to report the functional results and complication rates
of patients, eighteen to sixty-ﬁve years of age, who were randomized to receive either open reduction and plate ﬁxation or
intramedullary nail ﬁxation for a displaced midshaft clavicular
fracture (Plate or Pin [POP] study)11. The null hypothesis was
that plate ﬁxation would provide faster functional recovery
than intramedullary nail ﬁxation.
Materials and Methods
Study Design
T
he POP study, registered in the Dutch Trial Register (NTR 2438), was per12
formed in accordance with the Declaration of Helsinki and approved by the
local medical ethics committee (registration number V.10.365/R-10.18D/mg). From
January 2011 until August 2012, 120 consecutive patients with a displaced midshaft
clavicular fracture were included in this prospective trial in four participating
hospitals. Displacement was deﬁned as at least one shaft width of distance on any
radiograph between major fracture fragments, regardless of fracture shortening.
Power Analysis and Randomization
The sample size of sixty patients per group was based on an assumed clinically
relevant difference in the Disabilities of the Arm, Shoulder and Hand (DASH)
score of 6 points between the score of a healthy population and previously reported scores following conservative treatment of displaced midshaft clavicular
1,13
fractures . A more detailed rationale can be found in a previous description of
11
the study protocol .
Patients were recruited in the emergency departments and handed study
information if they met the inclusion criteria (Table I). Follow-up was scheduled
within a week after the trauma for study inclusion after informed consent was
obtained. Fractures were classiﬁed according to the AO/OTA classiﬁcation for
clavicular fractures.
Randomization to either plate ﬁxation or intramedullary nailing was
performed by central computerized block randomization in the doctor’s ofﬁce.
Analysis after treatment was carried out according to the intention-to-treat principle.
Block sizes ranged from two to eight patients with the two operative techniques
equally represented in each block. Additionally, the randomization procedure
11
was stratiﬁed by participating center .
Operative Technique
Plate Fixation
A single dose of prophylactic antibiotics was administered preoperatively. Patients
were placed in the beach-chair position and prepared in a standard fashion. A
longitudinal incision parallel to the clavicle, the length of which depended on the
fractured segment, was made, and the fracture was identiﬁed. Following fracture
reduction, a plate (DePuy Synthes, Amersfoort, the Netherlands) was positioned
on the anterosuperior surface of the clavicle and ﬁxed with nonlocking and
locking screws. The type of plate was selected according to the surgeon’s prefer-
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
ence. A minimum of three bicortical screws was placed on each side of the
fracture to ensure rigid ﬁxation. If interfragmentary compression was possible,
lag screws were placed ﬁrst. Only fractures with severe comminution were
11
treated with a bridging plate .
Intramedullary Nailing
Following administration of a single dose of prophylactic antibiotics, patients were
positioned in a supine position on a radiolucent table. A small incision was made
just lateral to the sternoclavicular joint, and the anterior cortex was opened with a
pointed reamer. A titanium elastic nail (DePuy Synthes, or Stryker, Waardenburg,
the Netherlands) was inserted from the medial side under ﬂuoroscopic control.
Fractures were reduced closed under image intensiﬁcation with percutaneous
clamps or, if closed reduction failed, in an open fashion with use of an additional
small incision over the fracture site, parallel to the clavicle. The length of the
incision was variable and at the discretion of the treating surgeon. After complete
introduction of the nail into the lateral fragment and compression of the fracture,
11
the nail was cut at the introduction point .
Postoperative Rehabilitation and Follow-up
Regardless of the type of operative ﬁxation, patients were given a sling for
comfort and encouraged to start active, non-weight-bearing mobilization as
soon as pain permitted. Weight-bearing was permitted after fracture consolidation (bridging bone or callus formation) was demonstrated radiographically.
All patients were followed clinically and radiographically in the outpatient clinic at two weeks, six weeks, three months, six months, and one year
after surgery by the treating surgeon and an independent researcher (F.-J.G.W.
or M.H.). Self-administered outcome questionnaires were completed prior to
the actual follow-up appointment.
Study End Points
11,13,14
The primary end point was the DASH score at six months
. The DASH is a
thirty-item subjective disability rating scale with scores ranging from 0 (no
13
disability) to 100 (complete disability) . DASH scores were also obtained at six
weeks, three months, and one year after surgery, and the subjective shoulder
function as measured by the DASH scores over the period between six weeks
and six months after the operation was assessed.
Secondary outcome measures included the Constant-Murley (CM) and
15,16
and a Likert scale for satisfaction with
Short Form-36 (SF-36) questionnaires
the cosmetic result (ranging from 0 for very unsatisﬁed and 10 for very satisﬁed).
The CM score assesses shoulder pain, motion, strength, and function and was
determined at the same time as the DASH score. Of the maximum score of 100
points, 35 points are derived from the patient’s self-assessment and 65 points
15
result from objective assessment . The SF-36 questionnaire, completed preoperatively and at six months and one year after surgery, measures health-related
quality of life and consists of thirty-six items covering eight health-related domains. Responses are summed and then transformed into a scale from 0 (poor
16
health) to 100 (good health) for each domain .
Recorded intraoperative data included the time of surgery, conversion of
the ﬁxation to the other type of ﬁxation, performance of open reduction in
patients undergoing intramedullary nail ﬁxation, and neurovascular complications. Complications were classiﬁed with a strategy similar to those used in re9,10
and included infection (superﬁcial or
cently published systematic reviews
deep), neurovascular problems (transient brachial plexus syndrome, hematoma,
and desensitized skin), implant-related problems (soft-tissue irritation, breakage,
and failure), bone-healing problems (nonunion and malunion), and ﬁnally
refracture after implant removal. The deﬁnition of a superﬁcial infection was
redness, swelling, and/or purulent discharge from the wound. If the infection
required surgical debridement and/or implant removal it was considered to be a
deep infection. Brachial plexus lesions were deﬁned as paresthesia of the arm and/
or weakness of the little and ring ﬁngers. Lesions were considered transient if
spontaneous recovery occurred within a six-month period. Soft-tissue irritation
was deﬁned as irritation due to a palpable implant. A lack of radiographic evidence
of healing with clinical evidence of pain and motion at the fracture site six months
after surgery was considered to indicate nonunion. Lastly, fracture union in a
615
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
shortened, angulated, or displaced position on radiographs with clinical symptoms was considered malunion.
Statistical Analysis
Data were analyzed according to the intention-to-treat principle. Baseline characteristics and postoperative outcome scores were compared by using either a
Student t test or a Mann-Whitney U test for continuous variables (baseline: body
mass index [BMI], age, and SF-36 domain scores; intraoperative: days between the
fracture and surgery and the duration of surgery; and end points: DASH and CM
scores at six months [comparison between study arms and between those who
underwent conversion and those who did not within the study arms], DASH and
CM scores during the six-month follow-up period, and SF-36 subscores [difference from baseline scores]). A Pearson chi-square test was used for categorical
parameters. Interpolation of missing shoulder scores proved to be most in concordance with the complete case approach and was therefore used as the imputation method for missing follow-up data. A general linear random-effects model
was run to study when differences in shoulder scores between the plate-ﬁxation
and nailing groups emerged during the ﬁrst half year.
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
Bivariate correlations between continuous variables were tested by using a Pearson or Spearman rho test. The complication rates at one year after
surgery were compared between the two interventions by using Poisson regression analysis. SPSS software (version 20.0; IBM, Armonk, New York) was
used for data analysis. Signiﬁcance was established at a p value of <0.05.
Source of Funding
This study was directly supported by an unrestricted CHF 90,500 research grant (Grant Number S-11-19V) by the AO Foundation (D¨ubendorf,
Switzerland).
Results
Baseline and Intraoperative Findings
f the 369 patients with a displaced midshaft clavicular
fracture, 120 were enrolled in this study: ﬁfty-eight were
randomized to receive plate ﬁxation and sixty-two, intramedullary nailing (Fig. 1). There were no signiﬁcant differences
O
Fig. 1
Flowchart of inclusion in the POP (Plate or Pin) study for ﬁxation of displaced midshaft clavicular fractures.
616
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
TABLE I Study Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Unilateral, dislocated midshaft clavicular fracture
Polytrauma
Age 18-65 yr
Open fracture
No preexisting shoulder pathology on affected side
Pathological fracture
No medical contraindications to general anesthesia
Fracture >1 mo old
Ability to provide informed consent
Neurovascular disorder
Ability to comply with follow-up
Moderate-to-severe head injury at time
of trauma (Glasgow Coma Scale [GCS] <12)
between the groups at baseline apart from the plate group having
a lower SF-36 score for vitality (64.5 versus 72.6 points; p = 0.03)
(Table II). At one year after surgery, three patients (3%), all in
the plate group, had been lost to follow-up. These patients did
not present for ﬁnal follow-up.
In the intramedullary nailing group, forty-six fractures
(74%) were reduced in an open fashion. One patient (2%) in
the plate group and six patients (10%) in the nailing group
underwent intraoperative crossover to the other treatment
group and were further analyzed as part of their original treatment group according to the intention-to-treat principle (see
Appendix). There was no association between conversion to the
other procedure and the outcome at six months (p = 0.42 in the
nailing group; the plate group was not tested because only one
patient underwent conversion). In addition, in the nailing group,
there was no association between the time from fracture to
surgery and the rate of open reduction (p = 0.97) or between
open reduction and the outcome (p = 1.0).
Primary and Secondary Outcomes
Neither the mean DASH score nor the mean CM score at six
months postoperatively differed signiﬁcantly between the groups
(Fig. 2). Until six months after surgery, the plate-ﬁxation group
experienced less disability than the nailing group as indicated
by the area under the curve of the DASH score (p = 0.02, Fig. 2-A).
At one year after surgery, there was no difference between the
groups in terms of satisfaction with the cosmetic appearance
(p = 0.67).
At six months, the bodily pain (p = 0.02) and vitality (p =
0.03) scores of the SF-36 subscales had improved more since
baseline in the plate-ﬁxation group than in the nailing group. At
twelve months, the change in the vitality score since baseline was
still greater (p = 0.02) in the plate-ﬁxation group (see Appendix).
Complications
In the plate-ﬁxation group, twenty-nine (50%) of the ﬁfty-eight
patients had a total of thirty-six complications (see Appendix).
Fig. 2
Fig. 2-A The DASH scores were 10.8 (standard error of the mean [SEM] = 1.4), 4.63 (SEM = 1.0), 3.0 (SEM = 0.8), and 2.4 (SEM = 0.6) points at six, twelve,
twenty-four, and ﬁfty-two weeks following plate ﬁxation and 15.1 (SEM = 1.7), 8.5 (SEM = 1.4), 5.6 (SEM = 1.3), and 3.9 (SEM = 1.1) points at the respective
follow-up periods after intramedullary nailing. The area under the curve for the postoperative period of six weeks through six months is also displayed.
Fig. 2-B The Constant-Murley scores were 91.9 (SEM = 1.4), 96.3 (SEM = 1.0), 96.0 (SEM = 0.8), and 99.2 (SEM = 0.4) points at six, twelve, twenty-four,
and ﬁfty-two weeks following plate ﬁxation and 84.1 (SEM = 2.0), 91.1 (SEM = 1.8), 95.5 (SEM = 1.5), and 91.3 (SEM = 1.5) points at the respective
follow-up periods after intramedullary nailing.
617
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
TABLE II Baseline Characteristics in Each Procedure Group
Age* (yr)
Plate Fixation (N = 58)
Intramedullary Nailing (N = 62)
P Value
38.4 ± 14.6
39.6 ± 13.2
0.64
53 (91%)
60 (97%)
Sex†
0.21
Male
Female
Caucasian†
5 (9)
2 (3%)
57 (98%)
61 (98%)
0.37
24.7 (3.5)
24.2 (3.0)
0.36
19 (33%)
38 (66%)
20 (32%)
42 (68%)
Yes
7 (12%)
7 (11%)
No
51 (88%)
55 (89%)
Right
50 (86%)
55 (89%)
Left
8 (14%)
7 (11%)
No
17 (29%)
20 (32%)
Yes
41 (71%)
42 (68%)
30 (52%)
28 (48%)
29 (47%)
33 (53%)
28 (48%)
25 (40%)
Sports
18 (31%)
29 (47%)
Fall from stance/height/other
12 (21%)
8 (13%)
Simple
27 (47%)
24 (39%)
Wedge
29 (50%)
34 (55%)
2 (3%)
4 (6%)
BMI*
(kg/m2)
Smoker†
Yes
No
0.90
Alcohol/drug abuse†
0.89
Hand dominance†
0.68
Sports activities†
0.73
Fracture side†
Right
Left
Trauma mechanism†
Trafﬁc accident
0.59
0.17
Fracture classiﬁcation†‡
Complex/comminuted
0.58
SF-36 score* (points)
Physical functioning
54.2 ± 22.5
55.9 ± 22.3
0.68
Role-physical functioning
Bodily pain
20.6 ± 38.1
36.9 ± 19.1
21.7 ± 34.3
41.9 ± 22.9
0.87
0.20
General health perception
80.7 ± 19.3
86.0 ± 16.1
0.16
Energy/fatigue (vitality)
64.5 ± 19.3
72.6 ± 20.5
0.03§
Social functioning
67.8 ± 30.2
75.4 ± 24.7
0.24
Role-emotional functioning
78.6 ± 38.4
83.1 ± 35.3
0.51
Mental health
80.9 ± 15.7
79.4 ± 16.1
0.61
*The values are given as the mean and standard deviation. †The values are given as the number with the percentage in parentheses. ‡Fractures
classiﬁed according to the AO/OTA classiﬁcation. §A signiﬁcant difference between groups.
In the intramedullary nailing group, thirty-nine (63%) of the
sixty-two patients had a total of forty-three complications. The
mean numbers of complications per patient, irrespective of their
severity, were similar in the two groups (plate ﬁxation: 0.67,
intramedullary nailing: 0.74; p = 0.65). In the nailing group,
irritation occurred on the medial side in thirty-one patients and
laterally in two patients (one patient in this group underwent
conversion to plate ﬁxation and had irritation from the plate).
In the plate-ﬁxation group, ﬁve additional patients had the
plate removed at their explicit request following fracture union.
Also, two patients in the nailing group had the intramedullary
device routinely removed under local anesthesia and ten had it
618
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
removed under general anesthesia to prevent future migration of
the implant according to the treating surgeon’s practice.
Discussion
o signiﬁcant difference in the primary study end parameter (the DASH score at six months postoperatively) was
noted between the two surgical interventions. However, plate
ﬁxation resulted in more rapid improvement in the DASH
score during the ﬁrst six months after surgery. The complications were mainly implant-related and, in total, similar between
the groups. The nailing group had slightly fewer complications
requiring major revision.
The DASH and CM scores at the time of ﬁnal follow-up
were comparable with previously reported values following
plate1,5,17 and intramedullary4,17,18 ﬁxation. We further assessed the
level of physical function between six weeks and six months and
demonstrated that plate ﬁxation led to better subjective function
in that period.
In general, the frequency of postoperative complications was
similar between the interventions. Medial protrusion of the titanium elastic nails was, however, a considerable problem, as it has
been in previous studies19,20. Since the medial end of the titanium
elastic nail cannot be locked, secondary shortening or rotation of
the clavicle can result in protrusion of the nail. A possible solution
for medial protrusion is the use of an end cap, which can be placed
over the medial end of the titanium elastic nail19. In addition, we
performed antegrade intramedullary ﬁxation. Perhaps retrograde
intramedullary nails and use of implants that are less prominent
may reduce the prevalence of (medial) protrusion21,22. Lateral protrusion occurred only when the lateral cortex was penetrated accidentally during the operation. In addition, the study protocol did
not include routine nail removal following fracture union. The
interhospital and intersurgeon variation of participating centers
in dealing with implant removal also in large part explains the
high frequency of implant irritation in the nailing group.
Care was taken to record symptoms of implant irritation
after both interventions, but this does not provide a valid explanation for the high frequency of plate irritation encountered,
especially when compared with previously reported data1,5.
Placement of the plate on the anteroinferior aspect of the clavicle
may be a solution to reduce implant irritation, but this may
inﬂuence the strength of the repair construct and fracture-healing
as a result of stripping of the muscular insertion23. The previously
appreciated and biomechanically conﬁrmed risk of refracture
following plate removal was also illustrated in this study9,24. This
ﬁnding stresses the importance of leaving plate-and-screw constructs in situ as long as possible and cautioning patients to avoid
high-risk activities during the ﬁrst months following removal.
The durations of both surgical procedures were similar to
previously reported values18,25. However, the number of open reductions in the intramedullary nailing group is remarkable considering that one of the advocated advantages of this antegrade
technique is closed reduction. A clear explanation for this high rate
of open reduction could not be found. All conversions from intramedullary nailing to plate ﬁxation involved fractures located in
the lateral part of the middle of the clavicular shaft. Even when the
N
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
smallest-diameter nails were used, the lateral fragment of the clavicle could not be entered. This raises the question of the suitability
of these fracture types for antegrade intramedullary ﬁxation. The
high rate of open reduction may explain the similarity between
intervention groups in terms of the patients’ satisfaction with the
cosmetic result. The one crossover in the plate group was the
result of a communication error about trial randomization.
Recent study results indicate that patients reach a steady
state of shoulder function one year after surgery26. The present
study showed similar levels of function at six months and one
year after surgery.
The strengths of this study include prospective randomization, power calculation, and the reporting of both objective and
subjective outcomes scores with sufﬁcient follow-up. In addition,
care was taken throughout the follow-up process to note complications and describe them in detail. Several limitations also
need to be addressed. The ﬁrst limitation is inherent to the study’s
multicenter and thus multisurgeon design, which may lead
to variations in and possibly unpredictable results. We believe,
however, that this reﬂects daily clinical practice in average hospitals and the results are therefore representative as an effectiveness trial design. Second, because of the differences in surgical
techniques, neither the patients nor the treating surgeons could
be blinded to the treatment group. In addition, all preoperative and postoperative data were collected by two investigators
(F.-J.G.W. and M.H.) who were also not blinded. However, the
use of a self-administered outcome questionnaire that was always
completed prior to the actual follow-up appointment limited
possible investigator-related bias.
Furthermore, collecting DASH baseline scores was not
planned in the original study protocol, disabling correction for
remaining differences between study groups after randomization. In contrast, the SF-36 scores were collected at baseline and
showed that the plate-ﬁxation group was less vital than the intramedullary nailing group. The larger gain in vitality scores in
the plate group at six and twelve months may have resulted from
regression to the mean and should be interpreted with caution.
The greater improvement in bodily pain scores in the plate
group between baseline and six months after surgery should
be assessed with the same caution as no signiﬁcant difference
between the study groups was observed in a secondary analysis
comparing the six and twelve-month SF-36 subscales scores
without correction for baseline. We suggest suspending judgment concerning possible differences in bodily pain and vitality
between the groups as additional study is needed.
Because we performed our analysis according to the
intention-to-treat principle, one of the major revisions in the
nailing group was actually of a plate in a patient who had undergone intraoperative conversion. However, the inﬂuence on the
ﬁnal outcome score was minimal.
Finally, study inclusion was not discussed with forty-four
potential participants because the attending surgeons did not
have the experience with either procedure that was required by
the study protocol. A retrospective comparison showed that the
characteristics of these excluded patients, such as age and fracture
pattern, were similar to those of the included patients.
619
TH E JO U R NA L O F B ON E & JOI NT SU RG E RY J B J S . ORG
V O LU M E 97-A N U M B E R 8 A P R I L 15, 2 015
d
d
d
In conclusion, both procedures showed satisfying functional results, but plate ﬁxation led to a faster recovery in the
ﬁrst six months after surgery. The rate of major complications
in the plate-ﬁxation group was slightly higher than that in the
nailing group. In both groups, the main complication was implantrelated irritation. Future research should focus on determining which ﬁxation type is appropriate for which fracture
pattern.
Appendix
Tables showing intraoperative ﬁndings in each procedure group, improvement in SF-36 subscale scores compared with baseline, and postoperative complications after
plate ﬁxation and intramedullary ﬁxation are available with
the online version of this article as a data supplement at
jbjs.org. n
P L AT E O R I N T R A M E D U L L A RY N A I L F I X AT I O N
M I D S H A F T C L AV I C U L A R F R A C T U R E S ?
FOR
D I S L O C AT E D
Egbert J.M.M. Verleisdonk, MD, PhD
Department of Surgery,
Diakonessenhuis Utrecht, P.O. Box 80250,
3508 TG Utrecht, the Netherlands.
E-mail address for E.J.M.M. Verleisdonk: ejverlei@diakhuis.nl
Marcel G.W. Dijkgraaf, PhD
Clinical Research Unit,
Academic Medical Center Amsterdam, Meibergdreef 9,
1105 AZ Amsterdam, the Netherlands
Sven A.G. Meylaerts, MD, PhD
Department of Surgery,
Medical Center Haaglanden, P.O. Box 432,
2501 CK The Hague, the Netherlands
Eric R. Hammacher, MD, PhD
Department of Surgery,
St. Antonius Hospital, P.O. Box 2500,
3430 EM Nieuwegein, the Netherlands
Michiel H.J. Verhofstad, MD, PhD
Department of Surgery,
Erasmus Medical Center, P.O. Box 2040,
3000 CA Rotterdam, the Netherlands
Olivier A. van der Meijden, MD, PhD
R. Marijn Houwert, MD, PhD
Martijn Hulsmans, MD
Frans-Jasper G. Wijdicks, MD, PhD
References
1. Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with
plate ﬁxation of displaced midshaft clavicular fractures. A multicenter, randomized
clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10.
2. McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild
LM, Potter J. Deﬁcits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40.
3. Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classiﬁcation. J Bone Joint Surg Br. 1998 May;80(3):476-84.
4. Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS.
Elastic stable intramedullary nailing versus nonoperative treatment of displaced
midshaft clavicular fractures-a randomized, controlled, clinical trial. J Orthop
Trauma. 2009 Feb;23(2):106-12.
5. Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, Foster CJ,
Clark K, Brooksbank AJ, Arthur A, Crowther MA, Packham I, Chesser TJ. Open reduction and plate ﬁxation versus nonoperative treatment for displaced midshaft
clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg
Am. 2013 Sep 4;95(17):1576-84.
6. Lenza M, Belloti JC, Gomes Dos Santos JB, Matsumoto MH, Faloppa F. Surgical
interventions for treating acute fractures or non-union of the middle third of the
clavicle. Cochrane Database Syst Rev. 2009;7(4):CD007428. Epub 2009 Oct 7.
7. Drosdowech DS, Manwell SE, Ferreira LM, Goel DP, Faber KJ, Johnson JA. Biomechanical analysis of ﬁxation of middle third fractures of the clavicle. J Orthop
Trauma. 2011 Jan;25(1):39-43.
8. Renfree T, Conrad B, Wright T. Biomechanical comparison of contemporary
clavicle ﬁxation devices. J Hand Surg Am. 2010 Apr;35(4):639-44.
9. Wijdicks FJ, Van der Meijden OA, Millett PJ, Verleisdonk EJ, Houwert RM. Systematic review of the complications of plate ﬁxation of clavicle fractures. Arch Orthop
Trauma Surg. 2012 May;132(5):617-25. Epub 2012 Jan 10.
10. Wijdicks FJ, Houwert RM, Millett PJ, Verleisdonk EJ, Van der Meijden OA. Systematic review of complications after intramedullary ﬁxation for displaced midshaft
clavicle fractures. Can J Surg. 2013 Feb;56(1):58-64.
11. Wijdicks FJG, Houwert RM, Dijkgraaf MGW, De Lange DH, Meylaerts SAG,
Verhofstad MHJ, Verleisdonk EJM. Rationale and design of the plate or pin (POP)
study for dislocated midshaft clavicular fractures: study protocol for a randomised
controlled trial. Trials. 2011;12:177. Epub 2011 Jul 15.
12. World Medical Association. WMA Declaration of Helsinki: ethical principles
for medical research involving human subjects. http://www.wma.net/en/
30publications/10policies/b3/index.html. Accessed 2015 Jan 12.
13. Hudak PL, Amadio PC, Bombardier C; The Upper Extremity Collaborative Group
(UECG). Development of an upper extremity outcome measure: the DASH (Disabilities of the Arm, Shoulder and Hand) [corrected]. Am J Ind Med. 1996 Jun;29(6):
602-8.
14. Gummesson C, Atroshi I, Ekdahl C. The Disabilities of the Arm, Shoulder and
Hand (DASH) outcome questionnaire: longitudinal construct validity and measuring
self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;
4:11. Epub 2003 Jun 16.
15. Constant CR, Murley AH. A clinical method of functional assessment of the
shoulder. Clin Orthop Relat Res. 1987 Jan;214:160-4.
16. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R,
Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the
Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998 Nov;51(11):1055-68.
17. Ferran NA, Hodgson P, Vannet N, Williams R, Evans RO. Locked intramedullary
ﬁxation vs plating for displaced and shortened mid-shaft clavicle fractures: a randomized clinical trial. J Shoulder Elbow Surg. 2010 Sep;19(6):783-9.
18. Assobhi JEH. Reconstruction plate versus minimal invasive retrograde titanium
elastic nail ﬁxation for displaced midclavicular fractures. J Orthop Traumatol. 2011
Dec;12(4):185-92. Epub 2011 Sep 27.
19. Frigg A, Rillmann P, Perren T, Gerber M, Ryf C. Intramedullary nailing of clavicular
midshaft fractures with the titanium elastic nail: problems and complications. Am J
Sports Med. 2009 Feb;37(2):352-9. Epub 2008 Dec 31.
20. Wijdicks FJ, Houwert M, Dijkgraaf M, de Lange D, Oosterhuis K, Clevers G,
Verleisdonk EJ. Complications after plate ﬁxation and elastic stable intramedullary
nailing of dislocated midshaft clavicle fractures: a retrospective comparison.
Int Orthop. 2012 Oct;36(10):2139-45. Epub 2012 Jul 31.
21. Millett PJ, Hurst JM, Horan MP, Hawkins RJ. Complications of clavicle fractures
treated with intramedullary ﬁxation. J Shoulder Elbow Surg. 2011 Jan;20(1):86-91.
Epub 2010 Nov 3.
22. King PR, Ikram A, Lamberts RP. The treatment of clavicular shaft fractures with
an innovative locked intramedullary device. J Shoulder Elbow Surg. 2015 Jan;24(1):
e1-6. Epub 2014 Jun 18.
23. Iannotti MR, Crosby LA, Stafford P, Grayson G, Goulet R. Effects of plate location
and selection on the stability of midshaft clavicle osteotomies: a biomechanical
study. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):457-62.
24. Smith SD, Wijdicks CA, Jansson KS, Boykin RE, Martetschlaeger F, de Meijer
PP, Millett PJ, Hackett TR. Stability of mid-shaft clavicle fractures after plate ﬁxation
versus intramedullary repair and after hardware removal. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):448-55. Epub 2013 Jan 31.
25. B¨ohme J, Bonk A, Bacher GO, Wilharm A, Hoffmann R, Josten C. [Current treatment concepts for mid-shaft fractures of the clavicle - results of a prospective multicentre study]. Z Orthop Unfall. 2011 Jan;149(1):68-76. Epub 2010 Oct 12. German.
26. Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function
plateaus by one year in patients with surgically treated displaced midshaft clavicle
fractures. Clin Orthop Relat Res. 2011 Dec;469(12):3351-5.