Background: Recent studies have shown a high prevalence of
symptomatic malunion and nonunion after nonoperative treatment of displaced
midshaft clavicular fractures. We sought to compare patient-oriented outcome
and complication rates following nonoperative treatment and those after plate
fixation of displaced midshaft clavicular fractures.
Methods: In a multicenter, prospective clinical trial, 132 patients
with a displaced midshaft fracture of the clavicle were randomized (by sealed
envelope) to either operative treatment with plate fixation (sixty-seven
patients) or nonoperative treatment with a sling (sixty-five patients).
Outcome analysis included standard clinical follow-up and the Constant
shoulder score, the Disability of the Arm, Shoulder and Hand (DASH) score, and
plain radiographs. One hundred and eleven patients (sixty-two managed
operatively and forty-nine managed nonoperatively) completed one year of
follow-up. There were no differences between the two groups with respect to
patient demographics, mechanism of injury, associated injuries, Injury
Severity Score, or fracture pattern.
Results: Constant shoulder scores and DASH scores were significantly
improved in the operative fixation group at all time-points (p = 0.001 and p
< 0.01, respectively). The mean time to radiographic union was 28.4 weeks
in the non-operative group compared with 16.4 weeks in the operative group (p
= 0.001). There were two nonunions in the operative group compared with seven
in the nonoperative group (p = 0.042). Symptomatic malunion developed in nine
patients in the nonoperative group and in none in the operative group (p =
0.001). Most complications in the operative group were hardware-related (five
patients had local irritation and/or prominence of the hardware, three had a
wound infection, and one had mechanical failure). At one year after the
injury, the patients in the operative group were more likely to be satisfied
with the appearance of the shoulder (p = 0.001) and with the shoulder in
general (p = 0.002) than were those in the nonoperative group.
Conclusions: Operative fixation of a displaced fracture of the
clavicular shaft results in improved functional outcome and a lower rate of
malunion and nonunion compared with nonoperative treatment at one year of
follow-up. Hardware removal remains the most common reason for repeat
intervention in the operative group. This study supports primary plate
fixation of completely displaced midshaft clavicular fractures in active adult
Level of Evidence: Therapeutic Level I. See Instructions
to Authors for a complete description of levels of evidence.