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Volume:1 Issue:10 Number:57 ISSN#:2563-5476
Meta-analysis
ACE Report #5426

Operative care of clavicle fracture reduces complications, nonunion, and malunion


Study Type:Meta analysis
OE Level Evidence:2
Journal Level of Evidence:N/A

Operative versus non-operative treatment for clavicle fracture: a meta-analysis

Int Orthop. 2013 Aug;37(8):1495-500

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Synopsis

5 randomized clinical trials and 3 controlled clinical trials (663 patients) were examined in this meta-analysis to determine if operative treatment provides better results than nonoperative treatment of clavicle fractures. The results from this meta-analysis suggest that operative care was associated with a reduced risk of non-union, malunion, and fewer neurological complications compared to nonoperative care. Statistical analysis of functional outcomes and long term adverse effects could not be completed due to incomplete reporting. However, qualitative assessment indicated that Constant Shoulder Scores and DASH scores were superior in the operative group.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
National Natural Science Foundation of China; Military Twelfth Five Key Projects; Foundation of State Key Laboratory of Trauma, Burns and Combined Injuries
Conflicts:
None disclosed

Risk of Bias

10/10

Reporting Criteria

18/20

Fragility Index

N/A

Were the search methods used to find evidence (original research) on the primary question or questions stated?

Was the search for evidence reasonably comprehensive?

Were the criteria used for deciding which studies to include in the overview reported?

Was the bias in the selection of studies avoided?

Were the criteria used for assessing the validity of the included studies reported?

Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?

Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?

Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?

Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?

How would you rate the scientific quality of this evidence?

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.

4/4

Introduction

4/4

Accessing Data

4/4

Analysing Data

3/4

Results

3/4

Discussion

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?

Clavicle fractures are an exceedingly common injury in adults. Until recently these injuries tended to be treated through nonoperative means. However, recent research has indicated that operative care may potentially result in fewer nonunions, malunions, delayed unions and neurological complications, while providing superior functional outcomes. This meta-analysis and systematic review aims to provide an update to current assessments in the literature.

What was the principal research question?

Does operative treatment of a fractured clavicle provide better clinical and functional outcomes compared to nonoperative treatment involving a sling or bandage?

Study Characteristics -
Data Source:
Online sources include MEDLINE, Embase, OVID, relevant articles from Google Scholar and the Cochrane Central Register of Controlled Trials up to December 2011
Index Terms:
Clavicle and fractures and (randomized controlled trial OR controlled clinical trial)
Study Selection:
Studies were included if they were randomized control trials or clinical control trials; provided a definite study period, sample size, and pathological diagnostic criteria; used operative and nonoperative therapeutic methods; performed high quality data collection; and compared CS, DASH score, nonunion, delayed union and complication outcomes. Studies were excluded if the sample size, grouping, pathological diagnostic criteria, control design and control source were undefined; non-therapeutic clinical studies or animal experiments were used; fracture not due to trauma, unscientific data collection was performed, no therapeutic outcome and review literature, retrospective studies and repeated reports.
Data Extraction:
Outcome data from the studies included in this meta-analysis was extracted by two authors independently.
Data Synthesis:
The statistical analysis of this data was completed with Review Manager 5.0 software. Continuous data and dichotomous data both had a 95% confidence interval and were organized as standardized mean differences and risk ratios respectively. Significantly heterogeneous (p>0.5) data was pooled with a random-effects model; non-significant heterogeneous data was pooled with a fixed-effects model.

What were the important findings?

  • 8 studies (I^2 = 0%) involving 566 patients indicated a reduced risk of nonunion for operative treatment compared to nonoperative (RR 0.12, 95 % CI 0.05-0.29) (p<0.0001).
  • 6 homogeneous (I^2 = 0%) studies with 453 patients indicated a decreased risk of malunion in the operative treatment (RR 0.11, 95 % CI 0.04-0.29) (p<0.0001).
  • 5 studies (I^2 = 29%) (337 patients) found no significant difference in the delayed union rates (RR 0.78, 95 % CI 0.31-1.95) (p=0.59).
  • 7 studies (I^2 = 28%) (468 patients) showed fewer neurological complications associated with operative treatment (RR 0.45, 95 % CI 0.25-0.80) (p=0.008).
  • A meta-analysis could not be competed on the CS and DASH scores due to incomplete reporting of standard deviation. A qualitative assessment of CS scores from 5 studies and DASH scores from 4 studies indicated superior results for operative treatment of clavicle fractures.

What should I remember most?

This meta-analysis supports operative measures for the treatment of a fractured clavicle based on reduced rates of nonunion, malunion and neurological complications. However, it should be noted that the functional outcomes examined (CS and DASH scores) were not included in the meta-analysis. Qualitative assessment of these outcomes indicated that operative treatment may provide superior function.

How will this affect the care of my patients?

Operative care of clavicle fractures effectively reduced the risks of non-union, malunion and neurological complications compared to non-operative treatment. Further research still needs to be conducted to identify specifically which types of clavicle fractures benefit the most from surgical fixation. Finally, treatment should be left to the discretion of the treating physician and patient preference.

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