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Operative fixation for midshaft clavicular fractures: outcomes, costs and complications
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December 2013
Operative fixation for midshaft clavicular fractures: outcomes, costs and complications
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
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):1576-84Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Two hundred patients, aged 16 to 60 years, with a completely displaced midshaft clavicular fracture were randomized to evaluate the efficacy of open reduction and plate fixation, against nonoperative treatments. Patients were assessed over 12 months for union, functional outcomes (DASH, Constant Score, and SF-12), complications, and cost of procedures. The evidence presented in this study demonstrated that operative treatments for displaced midshaft clavicular fractures result in lower rates of nonunion and superior functional outcomes, but is associated with higher implant-related complications and heavier costs. The authors of this study indicated a reluctance to accept operative fixation as the routine procedure for displaced midshaft clavicular fracture.
Publication Funding Details
+
Funding:
Non-funded
Conflicts:
Company Employee
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
2/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Evidence based consensus on the appropriate treatment for these injuries is lacking. Operative fixation for midshaft clavicular fractures has gleaned more popularity compared to the conventional nonoperative treatment options, but final consensus on a routine policy for treatment remains controversial. Operative treatments have been associated with lower rates of nonunion, shorter time to union and better functional outcomes but have contributed to higher rates of complications. This study was therefore needed to provide further evidence on the comparison between operative and nonoperative treatment for displaced midshaft clavicular fractures.
What was the principal research question?
Does open reduction and plate fixation in the treatment of displaced midshaft clavicular fractures present better outcomes compared against nonoperative treatment, measured over 12 months?
Study Characteristics
-
Population:
200 patients, aged 16 to 60 years, suffering from an isolated, completely displaced fracture of the middle three-fifths of the clavicle, which occurred within the 2 weeks prior to the study.
Intervention:
Operative Group: Patients underwent surgery using a Locking Clavicle Plate, where 3 screws were inserted in the primary medial and lateral fragments. The shoulder was subsequently immobilized in a collar and cuff for 3 weeks and received conventional physiotherapy treatment. (n= 95, 9 lost to follow-up; Mean Age: 32.3 years; M/F= 83/12)
Comparison:
Nonoperative Group: Patients received conventional therapy of a collar and cuff for 3 weeks and were subsequently directed to physiotherapy for range-of-motion exercises and strengthening. (n= 105, 13 lost to follow-up; Mean Age: 32.5 years; M/F= 92/13)
Outcomes:
Fracture union, defined as complete cortical bridging between proximal and distal fragments on 3D computed tomography, and functional status using: ROM, Short Form-12 (SF-12), Disabilities of the Arm, Shoulder, and Hand (DASH), and Constant questionnaires were assessed. Satisfaction (questionnaire), complications and economic evaluation were recorded
Methods:
RCT: Multi-Centered
Time:
Patients assessed at 3 and 6 weeks, and 3, 6, and 12 months
What were the important findings?
- 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)
What should I remember most?
Rates of nonunion were significantly reduced through open reduction and plate fixation when compared against nonoperative treatments for displaced midshaft clavical fractures. Nonoperative treatment was independently predictive of the development of nonunion. Disabilities of the Arm, Shoulder and Hand scores, along with Constant scores were significantly better with operative treatment at 12 months. However, when patients with nonunion were excluded from analysis, no significant differences in these scores were apparent. Operatively treated patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry compared to nonoperatively treated patients. Finally, open reduction and plate fixation was associated with significantly greater costs of treatment.
How will this affect the care of my patients?
Open reduction and plate fixation is superior for functional outcomes and rates of nonunion in patients suffering from displaced midshaft clavicular fracture when compared against nonoperative treatment, but the functional outcomes seem to be tied to the rates of nonunion. Operative treatment is expensive and associated with implant-related complications that do not arise with nonoperative treatment. For these reasons routine operative treatment cannot yet be supported for all patients. Future studies should aim to identify subgroups of patients that present with the greatest benefit of undertaking open reduction and plate fixation.
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