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Operative treatment of displaced mid-shaft fractures of the clavicle reduces complications
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June 2014
Operative treatment of displaced mid-shaft fractures of the clavicle reduces complications
Study Type:Meta analysis
OE Level Evidence:1
Journal Level of Evidence:N/A
Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials
J Bone Joint Surg Am. 2012 Apr 18;94(8):675-84Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
This meta-analysis identified 6 randomized clinical trials that compared operative and non-operative treatment of acute, displaced mid-shaft clavicle fractures. Results from this analysis indicate that there was a reduced complication rate in the operatively treated patients, with a decrease in non-unions and symptomatic malunions. A greater number of patients treated operatively were able to return to moderate activity 16 days following the injury, demonstrating that operative treatment provides superior early outcomes.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
St. Michaels Hospital Orthopaedic Research and Education Fund (to R.C.M.)
Conflicts:
Other
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?
The non-union rate of acute, displaced mid shaft fractures treated non-operatively has been reported to be as high as 15-20% and has detrimental effects on shoulder muscle strength. Based on these suboptimal outcomes for non-operative management, primary operative care has increased in popularity. The meta-analysis was conducted to evaluate treatment effects, potential harm and patient outcomes of these differing methods.
What was the principal research question?
Which treatment, operative or nonoperative, provides the best clinical and functional results, and what are the complications associated with these procedures for patients presenting with displaced mid-shaft fracture of the clavicle?
Study Characteristics
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Data Source:
A search for published randomized trials was conducted using the internet based resource MEDLINE. Content experts were contacted to identify unpublished trials and the trials currently in progress. The proceedings from a number of annual meetings were reviewed which included AAOS, OTA, ASES from 1990-2010.
Index Terms:
"Clavicle" and "fracture" randomized clinical trial was the study type limit
Study Selection:
Studies included were prospective randomized trials that compared operative and nonoperative treatment of acute, completely displaced mid-shaft fractures of the clavicle. The two senior authors of the paper reviewed the articles for inclusion.
Data Extraction:
Two senior authors independently extracted data from the included trials to a predetermined data extraction form. A third author reviewed the data for completeness and agreement. Disagreements were remediated through discussion and consensus.
Data Synthesis:
Data from the six identified studies was pooled, and summary estimates of treatment effects were calculated (relative risk with 95% CI). Homogeneity was assessed across the studies using the chi-square analysis, with p<0.10 set as the significance level. The RevMan software was used for graphical representation of polled data.
What were the important findings?
- Non-union rate was significantly higher in the non-operative patients (29/200), than in the patients treated operatively (3/212) (p=0.001)
- The rate of patients with a symptomatic malunion was signficantly greater in the non-operative group (17/200), compared to the operative group (0/200) (p<0.001)
- The overall complication rate was significantly greater in the non-operative group (84/200), compared to the operative group (62/212) (p=0.0075)
- Three studies reported Constant Shoulder scores at one year weighted operative average was 94.3 compared to the non-operative average of 90.2
- DASH scores appeared to favor the operative group, but only reported numerically in 2 studies and graphically in one
- Early return to moderate activity on the 16th day was possible in 80% of the operatively treated patients, compared to 55% in the non-operative patients
What should I remember most?
The results from this meta-analysis indicate that operative treatment of acute, displaced mid-shaft fractures of the clavicle provides a reduced rate of complication with fewer patients suffering non-union or symptomatic malunions. A greater number of operatively treated patients also were able to return to function earlier than the conservative treatment.
How will this affect the care of my patients?
The results from this meta-analysis support the use of primary operative treatment of acute, displaced mid shaft fractures of the clavicle.
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