Displaced midshaft fractures of the clavicle: non-operative treatment versus Synthes ® plate fixation. A multi-centre randomised controlled trial in the Netherlands.

The traditional view that the vast majority of clavicular fractures heal with
good functional outcomes following non-operative treatment is no longer valid.
Recent studies have identi*ed a higher rate of non-union and speci*c de*cits of
shoulder function in subgroups of patients with these injuries (7). Displaced
or comminuted mid-clavicular fractures carry a risk of malunion with cosmetic
deformity and recent studies have reported a rate of non-union of more than 15%
(5;8). While it is increasingly being accepted that the results of closed
treatment for some clavicular fractures are inferior to operative treatment, as
published in early reports, up until recently primary operative intervention
for dislocated fractures has not been shown superior. Numerous studies have
examined the safety and efficacy of primary open reduction and internal
fixation for completely displaced midshaft clavicle fractures and have noted a
high union rate with a low complication rate. However, most of these studies
were retrospective and only one recent study prospectively compared locking
plate fixation with non-operative treatment (6). Locking compression plates are
fracture fixation devices, with threaded screw holes that allow screws to lock
in the plate and function as a fixed-angle device. These plates may have a
mixture of holes that allow placement of both locking and traditional
non-locking screws (so-called combi plates). The locking plate fixation has
been compared in one randomised controlled trial with non-operative treatment
and showed favourable results for the locking plate fixation. Several other
methods exist to operatively stabilize a clavicular fracture, such as K-wire
and intramedullary fixation, but these types of fixation seem to be less solid
and relate to more complications than plating or non-operative management. With
improved implants, prophylactic antibiotics, and better soft-tissue handling,
plate fixation has become an adequate, safe and reliable technique (6). In a
meta-analysis, non-randomized, non-comparative, pooled data across all studies
showed that plating of 635 fractures resulted in a non-union rate of 2.5%,
which was significantly lower compared with 5.9% for non-operative treatment
(8). Looking at displaced fractures separately, plate fixation of 460 fractures
resulted in a non-union rate of 2.2%, which was significantly lower compared
with 15.1% for non-operative treatment. In a randomised clinical trial
comparing plating and non-operative treatment of 100% displaced midshaft
fractures, a non-union rate of 24% was reported for non-operative treatment and
0% for plating (8). In the non-operative group, 30% developed some symptoms of
upper extremity neurologic complaints during overhead use of the arm compared
to 6% in the operative group. In the non-operative group, 44% had complains
about the cosmetic appearance of the shoulder. However, 30% of the patients in
the plating group, requested hardware removal after healing of their fracture
(8;9) In the Canadian trial, minor and major complications after surgery were
frequently seen (37%), including wound infection, hardware irritation or
premature hardware failure which required removal. Although operation may
reduce the chance of developing pseudoarthrosis, the risk of complications has
to be carefully considered when the need for operative treatment is not
absolute (6;7). A retrospective study of the non-operative treatment of
displaced middle-third fractures of the clavicle showed that after at least
four years only 69% of the patients were satisfied with the final result. Eight
of the 52 fractures (15%) had developed nonunion. Thirteen patients had mild to
moderate residual pain and 15 had some evidence of brachial plexus irritation.
Of the 28 who had cosmetic complaints, only 11 would consider corrective
surgery. None of the patients had significant impairment of range of movement
or shoulder strength as a result of the injury. There was also a relatively
high incidence of other problems including pain and nerve compression syndromes
(10). In the





same study it was found that initial shortening at the fracture of more than
20 mm had a highly significant association with non-union (P<0.001) and an
unsatisfactory result. The authors recommend open reduction and internal
fixation of severely displaced fractures of the middle third of the clavicle in
adult patients(10). Locking compression plates introduce the possibility for
adequate and stable fixation of fragments with less regard to bone quality than
traditional plates. Another advantage is the reduced impairment of periosteal
blood supply due to the limited plate-bone contact. One of the most important
features of the operative treatment is early and active mobilization of the
shoulder. In the first two weeks pendulum exercises is started and more active
exercise is initiated between two and four weeks postoperatively. After six
weeks initial strengthening is started. The same method is followed for the
standard non-operative treatment.

Results of recent trials suggest that operative treatment with locking plate
fixation results in better functional outcomes than non-operative treatment.
Because more patients were lost to follow-up than anticipated in the main
randomised trial, sample size criteria were not met. Therefore a multi-centre
randomised clinical trial with sufficient power is needed to provide evidence
for a favoured treatment of dislocated midshaft fractures of the clavicle. In
this trial we will compare the locking compression plate of Synthes with the
non-operative treatment with sling for dislocated midshaft fractures of the
clavicle, analysing clinical results, complications, functional outcome and
quality of life.

This study will be a randomised, multi-centre trial that compares treatment of
fully displaced midshaft clavicular fractures with either non-operative
treatment or locking compression plate fixation. Approximately 350 patients
with clavicular fracture types 2B1 or 2B2 classified according to Robinson,
will be included. Clinical function, radiographic consolidation, functional
outcome, painscores, and quality of life will be monitored for each patient
during the first postoperative year (i.e. 2 weeks, 6 weeks, 3 months and 1
year). The analysis will be performed on *an intention to treat* basis. With a
power of 80 percent and a significance of 5 percent, based on a 15 percent
difference in scores between the two treatment groups, 156 patients in each of
the treatment arms need to be included. After informed consent has been
acquired, eligible patients will be selected and randomised in one of the two
treatment arms during a period of two years or until the necessary amount of
patients is reached. The follow-up period will be one year.

nvt

nvt