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Meta-Analysis
. 2019 Jan 22;1(1):CD009363.
doi: 10.1002/14651858.CD009363.pub3.

Surgical versus conservative interventions for treating fractures of the middle third of the clavicle

Mário Lenza  1 , Rachelle Buchbinder, Renea V Johnston, Bruno As Ferrari, Flávio Faloppa
Affiliations
Meta-Analysis

Surgical versus conservative interventions for treating fractures of the middle third of the clavicle

Mário Lenza et al. Cochrane Database Syst Rev. .

Abstract

Background: Clavicle fractures are common, accounting for 2.6% to 4% of all fractures. Eighty per cent of clavicle fractures are located in the middle third of the clavicle. Although treatment of these fractures is usually non-surgical, displaced clavicle fractures may be considered for surgical treatment because of their greater risk of non-union. This is an update of a Cochrane Review first published in 2013.

Objectives: To assess the effects (benefits and harms) of surgical versus conservative interventions for treating middle third clavicle fractures.

Search methods: We searched the Cochrane Bone, Joint and Muscle Trauma Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, trials registries and reference lists updated to December 2017. We did not apply any language or publication restrictions.

Selection criteria: We considered randomised and quasi-randomised controlled trials evaluating surgical versus conservative interventions for treating fractures in the middle third of the clavicle. The primary outcomes were shoulder function or disability, pain and treatment failure, defined as the number of participants who had been given a non-routine secondary surgical intervention (excluding hardware removal), for symptomatic non-union, malunion or other complications.

Data collection and analysis: At least two review authors selected eligible studies, independently assessed risk of bias and cross-checked data. Where appropriate, we pooled results of comparable studies.

Main results: We included 14 studies involving 1469 participants with acute middle third clavicle fractures. All studies included adults, with the overall range from 17 to 70 years. Of the studies that reported gender, men were over-represented. Ten studies compared plate fixation with sling or figure-of-eight bandage, or both, and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Almost all studies had design features that carry a high risk of bias, thus limiting the strength of their findings.Low-quality evidence from 10 studies (838 participants), showed that, compared with conservative treatment, surgical treatment of acute middle third clavicle fractures may not improve upper arm function at follow-up of one year or longer: standardised mean difference (SMD) 0.33, 95% confidence interval (CI) -0.02 to 0.67. We downgraded the quality of the evidence because of risk of bias and high statistical heterogeneity (I2 = 83%). This corresponds to a mean improvement of 2.3 points in favour of surgery (0.14 points worse to 4.69 points better), on the 100-point Constant score; this does not represent a clinically important difference. There may be no difference in pain measured using a visual analogue scale (0 to 100 mm; higher scores mean worse pain) between treatments (mean difference (MD) -0.60 mm, 95% CI -3.51 to 2.31; 277 participants, 3 studies; low-quality evidence reflecting risk of bias and imprecision). Surgery may reduce the risk of treatment failure, that is, number of participants who had non-routine secondary surgical intervention (excluding hardware removal), for symptomatic non-union, malunion or other complication (risk ratio (RR) 0.32, 95% CI 0.20 to 0.50; 1197 participants, 12 studies; low-quality evidence, downgraded for risk of bias and imprecision). The main source of treatment failure was mechanical failure (3.4%) in the surgery group and symptomatic non-union (11.6%) in the conservative-treatment group.We are uncertain whether surgery results in fewer people having one or more cosmetic problems, such as deformities, which were more common after conservative treatment, or hardware prominence or scarring, which only occurred in the surgery group (RR 0.55, 95% CI 0.31 to 0.98; 1130 participants, 11 studies; I2 = 63%; very low-quality evidence downgraded for risk of bias, imprecision and inconsistency). We are uncertain whether there is any difference between surgery and conservative treatment in the risk of incurring an adverse outcome that includes local infection, dehiscence, symptomatic malunion, discomfort leading to implant removal, skin and nerve problems: RR 1.34, 95% CI 0.68 to 2.64; 1317 participants, 14 studies; I2 = 72%; very low-quality evidence, downgraded for risk of bias, imprecision and inconsistency). Hardware removal for discomfort was a common adverse outcome in the surgery group (10.2%) while symptomatic malunion was more common in the conservative-treatment group (11.3% versus 1.2% in the surgery group). Infection occurred only in the surgery group (3.2%). There may be no between-group difference in quality of life at one year (SF-12 or SF-36 physical component scores: 0 to 100 scale, where 100 is the best score): MD 0.30 (95% CI -1.95 to 2.56, 321 participants, 2 studies; low-quality evidence downgraded for risk of bias and imprecision).

Authors' conclusions: There is low-quality evidence that surgical treatment has no additional benefits in terms of function, pain and quality of life compared with conservative treatment, but may result in fewer treatment failures overall. Very low-quality evidence means that we are very uncertain of the findings of a slightly better cosmetic result after surgery and of no difference between surgical and conservative treatment in the risk of adverse events. For both composite outcomes, there is a need to consider the balance of risks between the individual outcomes; for example, surgical adverse events, including wound infection or dehiscence and hardware irritation, against risk of adverse events that may be more commonly associated with conservative treatment such as symptomatic malunion and shoulder stiffness.Treatment options must be chosen on an individual patient basis, after careful consideration of the relative benefits and harms of each intervention and of patient preferences.

PubMed Disclaimer

Conflict of interest statement

Mário Lenza: no interests to declare Rachelle Buchbinder: no interests to declare Renea V Johnston: no interests to declare Bruno AS Ferrari: no interests to declare Flávio Faloppa: no interests to declare

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
4
4
Forest plot of comparison 1. Surgical versus conservative interventions, outcome: 1.1 Function (overall at the end of follow‐up ‐ one year or more)
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Ahrens 2017 {published data only}
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Koch 2008 {published data only}
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Melean 2015 {published and unpublished data}
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Mirzatolooei 2011 {published data only}
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Naveen 2017 {published data only}
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Robinson 2013a {published data only}
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Smekal 2009 {published and unpublished data}
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Tamaoki 2017 {published and unpublished data}
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Virtanen 2012a {published and unpublished data}
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Woltz 2017a {published data only}
    1. Stegeman SA. Displaced midshaft fractures of the clavicle: non‐operative treatment versus plate fixation. A multi‐centre randomised controlled trial in the Netherlands. ‐ Sleutel‐TRIAL. apps.who.int/trialsearch/Trial.aspx?TrialID=NTR2399 (accessed 4 May 2012).
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References to studies excluded from this review

ACTRN12610000948099 {unpublished data only}
    1. Clitherow HS. Displaced midshaft clavicle fractures: conservative management vs plate fixation. A multi‐centre randomised controlled trial. apps.who.int/trialsearch/Trial.aspx?TrialID=ACTRN12610000948099 (accessed 4 May 2012).
Bernstein 2007 {published data only}
    1. Bernstein J. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. Journal of Bone and Joint Surgery. American Volume 2007;89(8):1866‐7. - PubMed
Bohme 2011 {published data only}
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Bravo 2009 {published data only}
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Dugar 2013 {published data only}
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Jones 2014 {published data only}
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Jubel 2002 {published data only}
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Jubel 2005 {published data only}
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Khorami 2014 {published data only}
    1. Khorami M, Fakour M, Mokarrami H, Arti HR, Nasab AM, Shahrivar F. The comparison of results of treatment of midshaft clavicle fracture between operative treatment with plate and non‐operative treatment. Archives of Bone and Joint Surgery 2014;2(3):210‐4. - PMC - PubMed
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Kulshrestha 2011 {published data only}
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Madhukar 2015 {published data only}
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Malkoc 2016 {published data only}
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McIntosh 2016 {published data only}
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McKee 2010b {published data only}
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NCT00642265 {unpublished data only}
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    1. Vandekerckhove PJ, Berghs B, Vandendriessche G, Vanonverschelde J, Daele JVD, Wilde LD. The treatment of displaced, midshaft clavicular fractures: operative vs conservative. A prospected, randomized study . apps.who.int/trialsearch/Trial.aspx?TrialID=NCT00642265 (accessed 06 May 2012).
NCT01311219 {unpublished data only}
    1. White RA. Study comparing intramedullary nailing, plate fixation, and non‐operative treatment of clavicle fractures . apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01311219 (accessed 04 May 2012).
Parry 2017 {published data only}
    1. Parry JA, Straaten M, Luo TD, Simon AL, Ashraf A, Kaufman K, et al. Is there a deficit after nonoperative versus operative treatment of shortened midshaft clavicular fractures in adolescents?. Journal of Pediatric Orthopedics 2017;37(4):227‐33. - PubMed
Shukla 2014 {published data only}
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Simon 2010 {published data only}
    1. Simon P. Mid‐clavicle fractures in adults: surgery or not?. European Journal of Orthopaedic Surgery and Traumatology 2010;20(7):521‐5.
Smekal 2011 {published data only}
    1. Smekal V, Irenberger A, Attal RE, Oberladstaetter J, Krappinger D, Kralinger F. Elastic stable intramedullary nailing is best for mid‐shaft clavicular fractures without comminution: results in 60 patients. Injury 2011;42(4):324‐9. - PubMed

References to studies awaiting assessment

Dhakad 2016 {published data only}
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ISRCTN00825817 {unpublished data only}
    1. ISRCTN00825817. Open reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures. apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN00825817 (accessed 07 May 2012).
ISRCTN57483251 {unpublished data only}
    1. ISRCTN57483251. Assessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment. apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN57483251 (accessed 07 May 2012).
Shetty 2017 {published data only}
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Smith 2001 {published data only}
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References to ongoing studies

NCT00590850 {unpublished data only}
    1. NCT00590850. A multicenter, prospective, randomized trial of non‐operative versus operative treatment for high‐energy midshaft clavicle fractures. apps.who.int/trialsearch/Trial.aspx?TrialID=NCT00590850 (accessed 17 September 2017).
NCT01078480 {unpublished data only}
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NCT01483482 {unpublished data only}
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