A study examining clinical and functional outcomes after internal plate fixation of displaced midshaft clavicle fractures found that although the treatment reduces the risk of nonunion, it is associated with a significant risk of a secondary surgery. Results also revealed that, compared to conservative treatment, plate fixation does not improve shoulder function.
Clavicle fractures have traditionally been treated nonsurgically with good results. However, open reduction and internal fixation of these fractures is becoming increasingly popular, according to Sarah Woltz, MD, who presented the study at the 2016 Orthopaedic Trauma Association annual meeting. "Based on previous studies, there is no real consensus about whether patients are better off after surgical treatment," she said. "Our goal was to compare patient outcomes after plate fixation with those after nonoperative treatment for displaced midshaft clavicular fractures."
Level 1 evidence
The prospective study, conducted at 16 centers across The Netherlands, involved 160 patients. Study participants were predominantly male (91 percent), aged 18 to 60 years, and had a displaced midshaft clavicle fracture. Baseline characteristics among all patients were similar. Patients with the following were excluded:
- open fracture
- neurovascular damage
- pathological fracture
- other injury of ipsilateral arm
- Glasgow Coma Scale < 12
- late presentation (> 14 days after injury)
- no possibility for consent or follow-up
Patients were randomized to nonsurgical treatment with a sling (n = 74) or open reduction and plate fixation (n = 86), followed by motion exercises. The type of plate, incision, and plate position were not standardized.
The primary outcome measure was nonunion at 1 year. Additional outcome measures included secondary surgeries; Constant Shoulder, Disabilities of the Arm, Shoulder and Hand (DASH), and Short-Form 36 Health Questionnaire (SF-36) scores; and cosmetic results. All outcomes were recorded at 6 weeks, 3 months, and 1 year after injury.
Surgery yields mixed results
Primary outcome data were available on 148 patients (plate fixation = 83; nonsurgical treatment = 65). Incidence of nonunion at 1 year was 2.4 percent in the plate fixation group, compared to 23.1 percent in the nonsurgical group (P < 0.001). The rate of secondary surgeries was 27.4 percent in the plate fixation group, of which 16.7 percent were elective plate removals, and 17.1 percent in the nonsurgical group, (P = 0.18).
The researchers found no differences in the Constant and DASH scores between the two groups at 6 weeks, 3 months, and 1 year. However, Dr. Woltz pointed out, there was a significant loss to follow-up with respect to Constant scores, particularly within the nonsurgical group.
Additional analysis revealed that nonsurgically treated patients had slightly higher SF-36 scores than plate fixation patients after 6 weeks, and no differences in mental health status were found between the two groups at any point. In addition, all patients were similarly satisfied with the cosmetic results of their treatment at 1 year.
"Our study found that the main benefit of plate fixation for displaced midshaft clavicular fractures is the reduction in the risk of nonunion. However, it also imposes a considerable risk of complications without a clear functional benefit, underscoring the importance of patients and surgeons working together to choose the most suitable treatment option," said Dr. Woltz. "We found no evidence to support routine surgical treatment of displaced midshaft clavicular fractures."
Dr. Woltz's coauthors of "Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Multicenter Randomized Controlled Trial" are Sylvia A. Stegeman, MD, PhD; Pieta Krijnen, PhD; Bart A. van Dijkman, MD, PhD; Thom P.H. van Thiel, MD, PhD; Niels W.L. Schep, MD, MSc, PhD; Piet de Rijcke, MD, PhD; Jan Paul M. Frölke, MD; and Inger B. Schipper, MD, PhD.
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Maureen Leahy is the assistant managing editor of AAOS Now. She can be reached at email@example.com
- Plate fixation for displaced midshaft clavicle fractures reduces the risk of a nonunion, but increases the risk of a secondary surgery.
- Plate fixation also does not improve shoulder function, compared to nonsurgical treatment.
- Plate fixation may have some advantages over nonsurgical treatment in the short term.
- The results of this study do not support routine surgical treatment of displaced midshaft clavicular fractures.