Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial

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重要な知見は？

• Open reduction and plate fixation induced a significantly lower risk of nonunion with a 93% reduction in the risk compared against nonoperative procedures (p= 0.007): 16 of 92 nonoperative patients had nonunion, and 13 of these patients underwent secondary surgery. 8 had delayed union, resolving between 6 and 12 months. 1 of 86 (1.2%) operative group patients presented with nonunion and no delayed unions were reported.
• Treatment group allocation was independently predictive of nonunion on multivariate analysis (p= 0.0001) and smoking was significantly associated with nonunion (p= 0.006). Age, sex, increasing fracture displacement, and comminution were not predictive of nonunion on multivariate analysis or significantly associated with nonunion (each p> 0.05)
• DASH and Constant score evaluations revealed significantly favorable outcomes for both groups within 12 months (p< 0.001 for all), but mean functional scores were better for operatively treated patients at 3 (p< 0.05) and 12 months (Mean Dash: 3.4; Constant Score 92.0) compared to the nonoperative scores (Mean Dash: 6.1; Constant Score 87.8; p= 0.01). Constant score at 6 weeks and 6 months, and the DASH score at 6 months were not significantly different between groups (p> 0.05)
• SF-12 Scores between groups revealed no statistical differences. No differences between groups was apparent for active or passive shoulder ROM, or absences from work or sport (each p> 0.05). Comparisons for Local sensitivity/ irritation between groups revealed no significant differences (p= 0.2). 17 operative group patients compared to 11 nonoperative group patients expressed dissatisfaction.
• The number of patients at every assessment reporting dissatisfaction with shoulder drooping, clavicular bump at the fracture site, and shoulder asymmetry, was significantly lower in the open reduction and fixation group compared to the nonoperative group (p< 0.05 at each).
• Operative group patients presented with local symptoms of headache, hardware prominence, weather sensitivity, and incisional numbness. 10 (12%) patients subsequently underwent plate removal. No other unresolved intraoperative complications, postoperative neurological deficits, or deep infections were apparent.
• No significant differences between groups was apparent for overall number of secondary operative procedures or mandatory operations: 17 (18.5%) nonoperative group patients underwent secondary operative interventions within 12 months with 13 of 17 treatments considered mandatory for the treatment of nonunion. 16 (18.6%) operative group patients underwent secondary operative interventions with 5 of 16 considered mandatory for nonunion refracture and plate complications.
• Open reduction and plate fixation procedures presented with greater initial expenditure compared to nonoperative treatments. The cost of secondary reconstructive treatment fixations was higher during the first 12 months in the nonoperative group, but the overall cost of treatment in the 12 months after injury was significantly higher in the operative group (mean $2265.24 nonoperative versus $10,165.43; p< 0.001)