Intervention Review

You have free access to this content

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

  1. Mário Lenza1,*,
  2. Rachelle Buchbinder2,
  3. Renea V Johnston2,
  4. João Carlos Belloti3,
  5. Flávio Faloppa3

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 6 JUN 2013

Assessed as up-to-date: 10 MAR 2013

DOI: 10.1002/14651858.CD009363.pub2


How to Cite

Lenza M, Buchbinder R, Johnston RV, Belloti JC, Faloppa F. Surgical versus conservative interventions for treating fractures of the middle third of the clavicle. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD009363. DOI: 10.1002/14651858.CD009363.pub2.

Author Information

  1. 1

    Hospital Israelita Albert Einstein, Orthopaedic and Trauma Department, São Paulo, Sao Paulo, Brazil

  2. 2

    Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Monash Department of Clinical Epidemiology, Cabrini Hospital, Malvern, Victoria, Australia

  3. 3

    Universidade Federal de São Paulo, Department of Orthopaedics and Traumatology, São Paulo, São Paulo, Brazil

*Mário Lenza, Orthopaedic and Trauma Department, Hospital Israelita Albert Einstein, Av. Albert Einstein, 627/701, São Paulo, Sao Paulo, CEP 05651-901, Brazil. mariolenza@yahoo.com.br. mario.lenza@einstein.br.

Publication History

  1. Publication Status: Edited (no change to conclusions), comment added to review
  2. Published Online: 6 JUN 2013

SEARCH

 

Summary of findings    [Explanations]

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

 
Summary of findings for the main comparison. Surgical versus conservative interventions for treating fractures of the middle third of the clavicle

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

Patient or population: Patients with fracture of the middle third of the clavicle
Settings: Hospital
Intervention: Surgery

Comparison: Conservative intervention

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Conservative treatmentSurgical treatment

Function (overall)
Various tools
Follow-up: 12 months
Mean (SD) population Constant score 89 (7)1The mean difference in function (overall) in the intervention groups was
0.46 standard deviations higher
(0.06 lower to 0.98 higher)
SMD 0.46 ( 95% CI -0.06 to 0.98)429
(7 studies)
⊕⊕⊝⊝
low2,3
SMD 0.46 (-0.06 to 0.98); translates to absolute improvement of 3.2 points (0.4 points worse to 7 points improvement), 0 to 100 point Constant score in the surgery group. This is not a clinically significant difference.

Treatment failure (indication for non-routine secondary surgery)
Follow-up: 12 months
117 per 1000444 per 1000
(18 to 116)
RR 0.38
(0.15 to 0.99)
437
(5 studies)
⊕⊕⊝⊝
low2,5
Overall treatment failure in the conservative group is dominated by the results of COTS 2007 (16/24 = 67%). Of these, 9 were symptomatic malunions-this is an usually high number: Most malunions are asymptomatic or with mild symptoms with no need for other types of treatment.

Two trials had no treatment failures in either group.

Pain

(Visual analogue scale: 0 to 100 points)

Follow-up: 12 months
The mean pain in the control group was 7 pointsThe mean pain in the control group was 4 points lower (11.65 lower to 3.65 higher)MD -4.00 mm ( 95% CI -11.65 to 3.65)51 (1 study)⊕⊕⊝⊝
low2,5

Cosmetic result - total of cosmetic problems
Follow-up: 12 months
200 per 10006232 per 1000
(68 to 802)
RR 1.16
(0.34 to 4.01)
437
(7 studies)
⊕⊝⊝⊝
very low2,3,5

Infection and/or dehiscence
Follow-up: 12 months
0 per 1000See commentRR 6.11
(1.1 to 33.84)
218
(3 studies)
⊕⊕⊝⊝
low2,7
'Corresponding risk' cannot be calculated from assumed risk: This adverse effect is very unlikely in conservatively treated participants with closed fractures. Mean rate of infection and/or dehiscence based on data from 3 trials was 10/117 (8.5%), range 3.8% to 20.7%.

Hardware irritation requiring removal
Follow-up: 12 months
0 per 1000See commentRR 5.75
(1.53 to 21.65)
329
(5 studies)
⊕⊕⊝⊝
low2,7
'Corresponding risk' cannot be calculated from assumed risk: Hardware irritation should not occur in conservatively treated participants. Mean rate of hardware irritation based on data from 5 trials was 14/173 (8.1%), range 3.8% to 11.5%.

Quality of life Not measuredSee commentSee commentNot estimable-See commentNot measured in any trial.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio,

GRADE Working Group grades of evidence:
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1. This is based on the Constant score in healthy people as reported by the SD of the Constant score in healthy people as reported in Yian 2005.
2. All trials had methodological flaws; only two adequately concealed treatment allocation, and none blinded the outcome assessor.
3. Heterogeneity high as the result of a trial that showed an effect in the opposite direction to the other trials at 12 months, with no overlap of confidence intervals.
4. Basis for assumed risk was the mean baseline risk from the studies in the meta-analysis.
5. Total number of events was small; 95% confidence interval includes both no clinical effect, and 'appreciable benefit' (e.g. risk reduction of 15% fewer failures in surgery group).
6. Basis for assumed risk was the mean baseline risk from the studies in the meta-analysis.
7. Total number of events was small and was measured in only a few trials.

 

Background

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

The clavicle or collarbone has several important functions. It acts as a bridge connecting the upper limb to the thoracic cage, which helps to stabilise the shoulder girdle, while allowing the arm to perform a full range of movement. In addition, it functions as an attachment for muscles, provides protection to vital neurovascular structures, supports respiratory function and has a significant aesthetic role in a person’s physical appearance. These functions can be damaged by fracture of the clavicle (Kotelnicki 2006; Lazarus 2001).

 

Description of the condition

Clavicle fractures are common, accounting for 2.6% to 4% of all fractures, with an overall incidence of 36.5 to 64 per 100,000 people per year (Nordqvist 1994; Postacchini 2002). The most common site of fracture is the middle third of the clavicle, which accounts for 80% of all clavicle fractures (Neer 1984). Incidence is bimodal, with peak incidence in youth and in later life with male excess in the young and female excess in later life (Court-Brown 2006).

Two mechanisms of injury most typically result in clavicle fracture. The most common occurs after a fall onto the outer side of the shoulder and is seen in around 90% of cases. The other mechanism of clavicle injury happens after a fall onto an outstretched arm. The force of the fall is transmitted through the upper extremity to the clavicle, producing the fracture. Although this was previously believed to be the most frequent cause of injury, it represents only 2% to 5% of clavicle fractures (Jeray 2007b; Kotelnicki 2006). Falls as a result of sporting activities such as bicycling and skiing are common causes of clavicle fracture (Nowak 2000).

The diagnosis of clavicle fracture is easily made clinically on the basis of a typical history and the presence of bruising and deformity, which are often noted on examination. A single antero-posterior radiograph might confirm the diagnosis, and a second antero-posterior radiograph with a 45° cephalic tilt view could reveal characteristics of the fracture such as degree of displacement (Jeray 2007b).

Allman 1967 proposed a classification for clavicle fractures by dividing them into three groups according to their location along the bone: Group I consists of fractures in the middle third of the bone; group II includes fractures in the outer or lateral third of the bone; and group III contains fractures in the inner or medial third. In a large epidemiological study, Nordqvist 1994 classified 76% of all fractures as group I fractures; a median age of 13 years was found for participants in this group. Recently, because of the absence of a single system that has both prognostic and therapeutic value, Robinson 1998 proposed a modification of the Allman categories that includes prognostically important variables, such as degree of displacement and comminution (fragmentation of the bone).

 

Description of the intervention

Conservative or non-surgical interventions are widely used and are recommended for treating middle third clavicle fractures (Robinson 2004), given the generally low incidence of non-union after conservative treatment-with rates ranging from 0.03% to 5.9% (Nordqvist 1998; Robinson 2004; Zlowodzki 2005). Numerous conservative treatment options are available, the most common being the use of a sling or a figure-of-eight bandage (also known as a figure-of-eight splint, or a backpack bandage) or a combination of these two methods (Andersen 1987; Eiff 1997; Hill 1997). No consensus has been reached on the optimal duration of immobilisation; some have recommended two to six weeks (Eiff 1997; Jeray 2007b; Lazarus 2001).

Although absolute indications for surgical treatment are controversial, the most common indications for surgery include open fracture (an injury where a broken bone is open through the skin), severe displacement caused by comminution, high risk that the fracture will become open, and neurovascular injuries. Several surgical techniques of fixation can be implemented including internal fixation with screws, pins, wire loops, or plates; and external fixation with external fixators (Bradbury 1996; Ebraheim 1997; Jupiter 1987; Mullaji 1994). Bone grafting may also be used.

 

How the intervention might work

Whilst studies of undisplaced fractures have reported low rates of non-union (around 0.03%) (Nordqvist 1998; Robinson 2004; Zlowodzki 2005), studies of displaced fractures have found non-union rates of up to 15% (Canadian 2007; Hill 1997; McKee 2006). Fracture-related risk factors for non-union include open fracture, associated polytraumatic lesions, refracture, initial fracture displacement, comminution and shortening (Jupiter 1987; Marti 2003). Robinson 2004 observed that advanced age and female gender also predispose to non-union. These findings have prompted a recent increase in preference for surgical treatment, provided through the usual techniques of open reduction and internal fixation (using a plate and screw) or intramedullary fixation, using a metal rod that is inserted into the inner cavity (medulla) of the clavicle bone (approaching or not approaching the focus of the fracture) (Canadian 2007; Meier 2006).

 

Why it is important to do this review

Middle third fracture of the clavicle is one of the most common fractures of the body. It frequently results in short-term disability and pain, eventually causing longer-term deformity and disability. Before the current review was performed, two Cochrane reviews had separately considered different conservative interventions or different surgical interventions (Lenza 2009a; Lenza 2009b), but no Cochrane review had compared surgery with conservative treatment for these fractures. Lenza 2009a concluded that evidence from two trials is insufficient to establish the relative effects on final functional outcome of a figure-of-eight bandage compared with a sling, although the bandage may be associated with increased early pain. A third trial provided no evidence that therapeutic ultrasound accelerates recovery, including clinical fracture healing. Based on the results of three trials, Lenza 2009b concluded that evidence regarding the effectiveness of different methods of surgical intervention for treating acute fracture and non-union of the clavicle is limited and that further studies are justified. A majority of acute fractures used to be treated conservatively; however, current treatment of some types of clavicle fracture is more interventional, thus involving surgery (Judd 2009). This change merits investigation. An informed decision about the best treatment can be put forth only after available evidence is systematically reviewed to determine whether surgical or conservative interventions are preferred to treat some or all middle third clavicle fractures.

 

Objectives

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

 

Methods

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Criteria for considering studies for this review

 

Types of studies

We included randomised or quasi-randomised (method of allocating participants to a treatment that is not strictly random, e.g. by date of birth, hospital record number, or alternation) controlled trials that compared surgical versus conservative interventions for treating middle third clavicle fractures.

 

Types of participants

We included all studies of adolescents (age ≥ 10 years) and adults who had been diagnosed with middle third clavicle fracture. Studies that included children younger than 10 years of age were included if the proportion of children of this age was less than 10%, or if separate data were available.

We also included trials involving people who had a history of other shoulder injuries, provided separate data were presented for this population or the numbers included were small and balanced between the two groups. The same approach applied to trials including people with other concurrent shoulder injuries.

 

Types of interventions

All surgical and conservative interventions used to treat fractures of the middle third of the clavicle were considered.

We excluded trials comparing different techniques of surgical interventions alone, or different techniques of conservative interventions alone. Surgical interventions may include internal fixation using a plate-and-screw, Kirschner wires, titanium nail, Knowles pin and external fixation with an external fixator. Conservative interventions may include slings, strapping, figure-of-eight bandages and splints, or other physical treatments, as well as adjunctive therapies such as therapeutic ultrasound. We also considered for inclusion any trial that compared surgery with no treatment.

Closed reduction (re-aligning the fragments of the fracture) is not usually performed for clavicle fractures because the reduced position is practically impossible to maintain. However, we included all studies regardless of whether reduction was attempted or not.

 

Types of outcome measures

 

Primary outcomes

  • Function or disability, measured by upper limb functional outcome measures. Ideally, these should be patient-reported measures of function validated for people with clavicle fractures (however, we are not aware of any outcome measures in this category). An example of a validated patient-reported measure of upper limb function is the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) (Hudak 1996). A commonly used instrument for assessing shoulder function is the Constant score (Constant 1987), which is a composite score for shoulder function that includes subjectively rated pain and activities of daily living, as well as objectively rated range of movement and strength.
  • Pain. Preference was given to reports of pain measured using validated pain scales (visual analogue scale (VAS) or numerical rating scale (NRS)) and reported in terms of a clinically important change in pain score in the acute/short-term phase (e.g. proportion with at least 30% improvement in pain) or patient-reported long-term pain (e.g. proportion above 30/100-mm VAS scale, i.e. worse than mild pain). Examples are drawn from recommendations in Eccleston 2010 and Moore 2010.
  • Treatment failure measured by the number of participants who have undergone or are being considered for a non-routine secondary surgical intervention for symptomatic non-union, malunion or other complications (e.g. mechanical failure defined as a condition in which an implant loses its capacity to carry a load).

 
Timing of primary outcomes measurement

We extracted outcome data at the following time periods: short term follow-up (up to six weeks following treatment); intermediate follow-up (more than six weeks and up to six months after the end of treatment) and long-term (longer than six months after the end of treatment).

 

Secondary outcomes

  • Other treatment failure measured by:

    • Cosmetic result: deformity, asymmetrical result, unsightly scar, hardware prominence, etc.
    • Asymptomatic non-union (i.e. the fracture has not healed radiographically), defined as incomplete cortical bridging between proximal and distal fragments and radiographic malunion.

  • Adverse events measured by:

    • Short-term follow-up: local infection (e.g. wound infection) and/or dehiscence.
    • Long-term follow-up: symptoms of discomfort related to the implant, requiring removal; skin and nerve problems; stiffness/restricted range of shoulder movement.

  • Health-related quality of life measures, such as Short Form-36 (Ware 1992).
  • Numbers of participants returning to previous activities (work, sport, activities of daily living, etc), including time to return.

 

Search methods for identification of studies

 

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to 10 December 2012), the Cochrane Central Register of Controlled Trials (CENTRAL; in The Cochrane Library 2012, Issue 11), MEDLINE (1966 to 10 December 2012), EMBASE (1980 to 2012 Week 40), and LILACS (1982 to 10 December 2012). We also searched the WHO International Clinical Trials Registry Platform and the ClinicalTrials.gov registry for ongoing and recently completed studies (to December 2012). No restrictions based on language or publication status were applied.

In MEDLINE (PubMed), the first two phases of the Cochrane highly sensitive search strategy for reports of randomised controlled trials (Higgins 2006) were combined with the subject-specific search (Appendix 1). The EMBASE (Ovid Online) search strategy was combined with the RCT search filter developed by SIGN (Appendix 1). Search strategies for The Cochrane Library (Wiley Online Library) and LILACS are also shown in Appendix 1.

 

Searching other resources

We checked the reference lists of articles and reviews for possible relevant studies.

 

Data collection and analysis

The intended methodology for data collection and analysis was described in our published protocol (Lenza 2011), which was based on the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).

 

Selection of studies

Two authors (ML and FF) independently selected potentially eligible studies for inclusion in the review, using a pre-piloted form. Any disagreements were resolved by discussion and, when necessary, with adjudication by a third author (JB). The review authors were not blinded to the journal or to the authors.

 

Data extraction and management

Two review authors (ML and FF) extracted the following data using a pre-piloted data extraction form: characteristics of the study methods including study design, duration of the study, whether the protocol was published before recruitment of participants, funding sources and details of trial registration; characteristics of the study participants including place of study, number of participants assigned, number of participants assessed, inclusion criteria, exclusion criteria, age and classification of injury; characteristics of the study interventions including timing of intervention, type of surgical intervention, type of conservative intervention, rehabilitation and any co-interventions; characteristics of the study outcomes including length of follow-up, loss of follow-up and outcome measures; and the methodological domains as outlined later in Assessment of risk of bias in included studies.

Any disagreements were resolved by a third review author (JB). Two review authors (ML and FF) entered data into Review Manager. Requests seeking additional information or data were sent to trial authors.

 

Assessment of risk of bias in included studies

The risk of bias of included studies was assessed by two independent review authors (ML and FF). As recommended by The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011b), the following domains were assessed:

  • Random sequence generation.
  • Allocation concealment.
  • Blinding of participants and personnel.
  • Blinding of outcome assessment.
  • Incomplete outcome data.
  • Selective reporting.
  • Other bias (e.g. major baseline imbalance; inappropriate influence of funders; risk of bias associated with inexperience of surgeons and other care providers with the interventions, differences in rehabilitation).

Each of these criteria was explicitly judged on the basis of low risk of bias, high risk of bias, and unclear (either lack of information or uncertainty over the potential for bias). Disagreements between authors regarding the risk of bias for domains were resolved by consensus.

 

Measures of treatment effect

We calculated risk ratios (RRs) together with 95% confidence intervals (CIs) for dichotomous outcomes.

Continuous outcome data were expressed as mean differences (MDs) with 95% CIs.

When appropriate, we reported the number needed to treat to benefit (NNTB) with 95% CIs and the number needed to treat to harm (NNTH) with 95% CIs.

 

Unit of analysis issues

The unit of randomisation in the studies included in this review is usually the individual participant.

 

Dealing with missing data

We attempted to extract outcome data for all participants randomly assigned into each trial. We tried to contact the authors of primary studies to request missing data, such as numbers of participants, details of dropouts, means, measures of variance (standard deviation or standard error), and numbers of events.

For continuous outcomes with no standard deviations reported, we planned to calculate standard deviations from standard errors, P values, or confidence intervals, according to the methods outlined in Higgins 2011c. We described missing data and data on dropouts for each included study in the 'Risk of bias' table, and we discussed the degree to which missing data could change the results and conclusions of this review.

The effects of dropouts and exclusions were investigated by conducting worst- and best-case scenario analyses. For dichotomous outcomes, we analysed the worst-case scenario using the number randomly assigned as denominator, with the assumption that any participants missing at the end of treatment did not have a positive outcome (e.g. for the outcome number of participants experiencing treatment failure, we assumed that any missing participants had an adverse event). We analysed the best-case scenario using the number randomly assigned in the denominator, and ignoring the dropouts in our analyses of dichotomous outcomes (overall treatment failure).

 

Assessment of heterogeneity

The heterogeneity of estimate effects between included studies was assessed by visual inspection of the forest plot (analysis) along with consideration of the test for heterogeneity and the I² statistic. We quantified the possible magnitude of inconsistency (i.e. heterogeneity) across studies, using the I² statistic with a rough guide for interpretation as follows: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; and 75% to 100% considerable heterogeneity (Deeks 2008). In cases of considerable heterogeneity (defined as I² ≥ 75%), we explored the data further by comparing the characteristics of individual studies and conducting subgroup analyses.

 

Assessment of reporting biases

We planned to draw funnel plots of primary outcomes to assess the potential publication bias (small study effects). However, the small number of included studies precluded this form of analysis. We assessed the presence of small study bias in the overall meta-analysis by checking whether the random-effects estimate of the intervention effect was more beneficial than the fixed-effect estimate (Sterne 2008).

We also assessed outcome reporting bias by comparing results extracted from published journal reports with results from other sources (e.g. correspondence) and by checking trial registrations (at the WHO International Clinical Trials Registry Platform) or published protocols.

 

Data synthesis

When appropriate, results of comparable groups of studies were pooled in meta-analysis using the random-effects model as a default. For dichotomous outcomes we calculated pooled RR with 95% CI. When two or more studies presented continuous data derived from the same validated instrument of evaluation using the same units of measure, data were pooled as a mean difference (MD) with 95% CI. When primary studies express the same variable using different instruments and different units of measure, we used the standardised mean difference (SMD) with 95% CI.

 

Subgroup analysis and investigation of heterogeneity

We planned to perform subgroup analyses for the following:

  • Age (adolescents, adults and people older than 65).
  • Type of surgical intervention: intramedullary fixation versus plate fixation.
  • Timing of surgery: immediate versus delayed (from one week to four weeks after injury).
  • Two fragments versus more than two fragments.
  • Primarily undisplaced versus displaced.

Details of the actual subgroup analyses conducted are given in Effects of interventions.

 

Sensitivity analysis

We planned sensitivity analyses to assess the effects of including trials at risk of selection bias (inadequate or unclear allocation concealment) or detection bias (inadequate or unclear blinding of outcome assessor); and of including participants with a history of shoulder injuries. We also planned to assess the presence of small study bias (i.e. intervention effect is more beneficial in smaller studies) in the meta-analysis by comparing the fixed-effect estimate with the random-effects estimate for primary outcomes.

We conducted sensitivity analyses to investigate the effects of any missing data by conducting worst- and best-case scenario analyses.

 

'Summary of findings' tables

We presented the main results of the surgical versus conservative treatment comparison in a 'Summary of findings' (SoF) table. The SoF table provides key information concerning the quality of the evidence, the magnitude of effect of the interventions examined and the sum of available data on the main outcomes.

 

Outcomes for 'Summary of findings' table

We included the following outcomes in 'Summary of findings' tables: upper limb functional outcomes; pain; treatment failure (non-routine secondary surgical intervention for symptomatic non-union, malunion or other complications); cosmetic results; local infection; hardware irritation requiring removal and health-related quality of life. The SMD result for the upper limb function outcome was converted to a clinically meaningful measure of function (Constant score) by multiplying the SMD by the SD of the Constant score in healthy people as reported in Yian 2005.

 

Results

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Description of studies

See: Characteristics of included studies, Characteristics of excluded studies and Characteristics of ongoing studies.

 

Results of the search

The search strategy (completed December 2012) identified a total of 456 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (30 records); Cochrane Central Register of Controlled Trials (28), PubMed (119), EMBASE (150), LILACS (17), ClinicalTrials.gov (61) and the WHO International Clinical Trials Registry Platform (51). We also identified four potentially eligible studies from other sources (by the studies that were included in other published reviews).

The search resulted in identification of the citations of 42 reports of potentially eligible studies, for which (where possible) full reports were obtained. A total of eight studies with data published across other publications (18 reports), published between 2007 and 2012, were included in the review (Chen 2011; COTS 2007; Figueiredo 2008; Judd 2009; Koch 2008; Mirzatolooei 2011; Smekal 2009; Virtanen 2012a). Just one trial was preceded by trial registration (Virtanen 2012a).

Overall, there are eight included studies, 10 excluded studies, eight ongoing studies and three studies awaiting classification (Figure 1).

 FigureFigure 1. Study flow diagram

 

Included studies

Details of the eight included studies can be found in Characteristics of included studies.

One trial, COTS 2007, reported its results in abstract format (Hall 2006) and then presented different results (different time points and/or outcomes) across three separate publications (COTS 2007; Pearson 2010; Schemitsch 2011). Koch 2008 reported the same results in two papers (Koch 2008; Witzel 2007). Judd 2009 was initially reported in 2005 in an abstract (American Academy of Orthopaedic Surgeons (AAOS)) and then published in full in 2009. Virtanen 2012a was also published as a conference proceeding and was commented on in a letter. Each of the remaining four trials reported results in a single publication (Chen 2011; Figueiredo 2008; Mirzatolooei 2011; Smekal 2009). We did not use conference abstract data in our analyses.

All trials were reported in English, except Koch 2008 (in German) and Figueiredo 2008 (in Portuguese). Both were translated into English by one review author (ML).

 

Design

All studies were parallel randomised controlled trials with two intervention groups. COTS 2007 was a multi-centre trial conducted in eight centres in Canada; all other studies were single-centre setting trials. Chen 2011 took place in China; Figueiredo 2008 in Brazil; Judd 2009 probably in Hawaii; Koch 2008 in Germany; Mirzatolooei 2011 in Iran; Smekal 2009 in Austria; and Virtanen 2012a in Finland.

 

Sample sizes

The eight trials enrolled a total of 555 participants; outcome data allowing analysis by the trial authors were available for a maximum of 497 participants (89.5%).

 

Participants

 
Age and gender

COTS 2007 stipulated an age limit between 16 and 60 years old; Figueiredo 2008 excluded participants who were younger than 18 years of age; Judd 2009 excluded participants who were younger than 17 years of age or older than 40 years; Chen 2011, Mirzatolooei 2011 and Smekal 2009 included adults between 18 and 65 years old, and Virtanen 2012a between 18 and 70 years old. Age was not specified in the inclusion criteria of Koch 2008. Seventy-seven per cent of the 497 participants with outcome data were male.

 

Types/classification of fractures

All studies included only participants with displaced or angulated middle third clavicle fracture. Only Chen 2011, Smekal 2009 and Virtanen 2012a used the AO classification (Muller 1991) to characterise their populations. Potential participants with open fractures were excluded from all studies other than Mirzatolooei 2011, in which 20% of study participants had an open clavicle fracture.

 

Interventions

Based on the method of surgical fixation, included trials could be grouped into two comparisons:

  • Comparison 1: surgical intervention using plate fixation versus conservative intervention using a sling (COTS 2007; Figueiredo 2008; Mirzatolooei 2011; Virtanen 2012a). Follow-up data were available for 252 participants (138 with surgical and 114 with conservative intervention).
  • Comparison 2: surgical intervention using intramedullary fixation versus conservative intervention using sling or figure-of-eight bandage (Chen 2011; Judd 2009; Koch 2008; Smekal 2009). Follow-up data were available for 245 participants (124 with surgical and 121 with conservative intervention).

 

Outcome measures

The studies varied in timing of follow-up. Four studies specified follow-up time points at one and/or two years: COTS 2007 reported follow-up data for one year, and a subsequent publication (Schemitsch 2011) presented data for two years; Judd 2009, Mirzatolooei 2011 and Virtanen 2012a conducted follow-up to one year; and Smekal 2009 reported data after two years of follow-up. Three studies reported mean follow-up: Chen 2011 presented a mean follow-up of 15 months, Figueiredo 2008 reported a mean follow-up of 16 months and Koch 2008 reported a mean follow-up of 19 months.

 

Primary outcomes

 
Function or disability

Shoulder function or disability was evaluated by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and the Constant score in Chen 2011, COTS 2007, Mirzatolooei 2011, Smekal 2009 and Virtanen 2012a. Figueiredo 2008 used the UCLA score and Judd 2009 included both the Single Assessment Numeric Evaluation (SANE) and L’Insalata shoulder scores to assess shoulder function or disability. Koch 2008 did not evaluate this primary endpoint.

 
Pain

Only two trials assessed pain (Koch 2008; Virtanen 2012a). Koch 2008 used a VAS scale with a range of 0 to 10 cm (with 0 indicating no pain and 10 indicating maximum pain); Virtanen 2012a used a VAS scale with a range of 0 to 100 mm.

 
Treatment failure

Treatment failure was measured by all trials as the number of participants who had undergone a non-routine secondary surgical intervention (excluding hardware removal) for symptomatic non-union, malunion or other complication.

 

Secondary outcomes

 
Other treatment failure

All trials reported cosmetic results; Mirzatolooei 2011 and Virtanen 2012a also assessed asymptomatic non-union and malunion.

 
Adverse events

COTS 2007 assessed wound infection and/or dehiscence, hardware irritation and/or prominence, skin and nerve problems and stiffness. Figueiredo 2008 and Koch 2008 measured restriction of shoulder motion. Judd 2009 evaluated superficial and deep infection, discomfort related to the implant and partial nerve injury. Mirzatolooei 2011 evaluated wound infection, skin dysaesthesia, hypertrophic scar, weakness, limitation of motion and plate elevation. Smekal 2009 assessed transient neurogenic compromise; telescoping and medial nail protrusion. Virtanen 2012a measured hardware irritation and refracture.

Chen 2011 presented an unclear and incomplete account of adverse events in their trial.

 
Health-related quality of life

Health-related quality of life was reported to have been measured using the SF-36 questionnaire (health and function status) in a publication of COTS 2007 (Pearson 2010); however, the authors did not report their results. No other trial reported health-related quality of life data.

 
Return to previous activities

Return to previous activities endpoints were described by Figueiredo 2008 (work and activities of daily living) and Koch 2008 (sport activities).

 

Excluded studies

Ten studies were excluded because they did not meet our inclusion criteria. The full reasons for excluding these studies are provided in Characteristics of excluded studies.

 

Studies awaiting classification

One trial (Smith 2001) is awaiting classification pending the receipt of further information on study characteristics and data. Given that this trial was presented in 2000 and in 2001 at conferences, it seems likely that the full results will remain unpublished. Two other trials, whose details are available only in a trial registry, are classified as awaiting classification because of their "completed" status; however, no reports of these trials have been identified. Details of these trials can be found in Characteristics of studies awaiting classification.

 

Ongoing studies

Our search for ongoing trials led to 44 studies on the WHO International Clinical Trials Registry Platform and 49 on the ClinicalTrials.gov register. Excluding duplicates (N = 21), 64 either were not relevant or did not meet our inclusion criteria, leaving a total of eight studies to be included in an updated version of this review when they are published (ACTRN12610000948099; ISRCTN66495030; Longo 2011; NCT00590850; NCT00642265; NCT01078480; NCT01483482; Stegeman 2011). Published protocols, indexed in PubMed, for two of the ongoing trials are available (Longo 2011; Stegeman 2011).

All ongoing studies are parallel randomised controlled trials with two intervention groups. Longo 2011 and Stegeman 2011 are multi-centre trials: Longo 2011 is taking place in the United Kingdom and Stegeman 2011 in the Netherlands. The other ongoing trials appear to be single-centre trials, taking place in Belgium (NCT00642265), Brazil (ISRCTN66495030), Denmark (NCT01078480 and NCT01483482), New Zealand (ACTRN12610000948099) and the United States (NCT00590850). The eight ongoing studies should enrol a total of 1748 participants.

Further details of the eight ongoing studies can be found in Characteristics of ongoing studies.

 

Risk of bias in included studies

All trials had methodological flaws, rendering them at high risk of bias (see Figure 2 and Figure 3).

 FigureFigure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
 FigureFigure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

 

Allocation

COTS 2007 and Virtanen 2012a reported that random sequence generation was performed using a computer random number generator and Smekal 2009 by throwing dice. The five remaining trials (Chen 2011; Figueiredo 2008; Judd 2009; Koch 2008; Mirzatolooei 2011) did not provide sufficient information about the sequence generation process to permit a judgement about bias.

Concealment of allocation before assignment was adequate for COTS 2007, Judd 2009, Mirzatolooei 2011 and Virtanen 2012a (opaque and sealed envelopes). Chen 2011, Figueiredo 2008 and Koch 2008 did not describe their methods of allocation concealment. Smekal 2009, which used envelopes, provided insufficient information to permit judgement.

 

Blinding

All trials were judged to be at high risk of performance and detection bias. As they all compared surgery with conservative treatment, it was not possible to blind treatment providers. No trials included sham surgery; therefore participants were not blinded. It may have been possible to blind outcome assessors; however, none of the trials mentioned assessor blinding.

 

Incomplete outcome data

We considered trials to be at low risk of bias if more than 80% of participants completed the follow-up, missing outcomes data were balanced in number across intervention groups and an intention-to-treat analysis was reported for the primary outcomes. As a result, four trials (Chen 2011; Koch 2008; Smekal 2009; Virtanen 2012a) were at low risk of attrition bias, three (COTS 2007; Judd 2009; Mirzatolooei 2011) were at high risk and one (Figueiredo 2008) was classified as unclear.

COTS 2007 and Judd 2009 were judged to be at high risk of bias because significantly more participants in the conservatively treated group were lost to follow-up at 12 months (16 (25%) and 5 (7%) respectively in COTS 2007; and 5 (18%) and 2 (7%) respectively in Judd 2009). Mirzatolooei 2011 and Smekal 2009 did not perform an intention-to-treat analysis. Figueiredo 2008 was judged to be at unclear risk because data were available at 15 months post-intervention for only 40/50 (80%) participants, and no information was provided on the numbers missing from each group to allow assessment of whether there was an imbalance.

 

Selective reporting

Only one trial (Virtanen 2012a) was considered at low risk of bias because the study protocol was available and all of the study’s pre-specified outcomes that are of interest for this review have been reported in the pre-specified way.

The other included trials (Chen 2011; COTS 2007; Figueiredo 2008; Judd 2009; Koch 2008; Mirzatolooei 2011; Smekal 2009) were classified at high risk of bias. One or more outcomes of interest in the review were reported incompletely in Chen 2011, COTS 2007 and Figueiredo 2008. Judd 2009 assessed function or disability using non-usual validated patient-reported measures. Koch 2008 did not measure function or disability by validated patient-reported measures. Neither Mirzatolooei 2011 or Smekal 2009 presented baseline data for efficacy outcomes and reported only P values.

 

Other potential sources of bias

Two trials (Judd 2009; Virtanen 2012a) were at low risk of other bias, and six trials (Chen 2011; COTS 2007; Figueiredo 2008; Koch 2008; Mirzatolooei 2011; Smekal 2009) were at high risk of other potential threats to validity.

Time points of outcomes were not pre-specified in Chen 2011 and Figueiredo 2008. Four trials did not provide baseline outcome data, so we were unable to assess whether groups were balanced at baseline (COTS 2007; Koch 2008; Mirzatolooei 2011; Smekal 2009).

We were not able to analyse performance bias related to differences in rehabilitation and experience of surgeons and other care providers because the included trials did not report information related to these.

 

Effects of interventions

See:  Summary of findings for the main comparison Surgical versus conservative interventions for treating fractures of the middle third of the clavicle

The primary comparison in this review was any surgical intervention versus any conservative intervention. Secondary subgroup analyses by types of surgical interventions (plate fixation and intramedullary fixation) are presented for function and primary treatment failure. Further subgroup analyses were precluded by insufficient data.

 

Comparison: Surgical versus conservative interventions for treating middle third clavicle fractures

 

Function or disability

For the purpose of pooling data for the  Summary of findings for the main comparison, where trials included more than one measure of function, we preferentially included one measure according to the following hierarchy: Constant score, DASH score, UCLA score, SANE score and L'Insalata score.

The variety of measures used to demonstrate overall function in the included trials is displayed in the analyses (see  Analysis 1.1). Pooled data from seven trials demonstrated no significant difference between the two groups (standardised mean difference [SMD] 0.46, 95% CI -0.06 to 0.98) at follow-up of one year or more; however, these results were highly heterogeneous (I² = 85%).This result equates to an absolute mean difference of 3.22 points improvement (0.42 points worse to 6.86 points improvement) in favour of surgery on the Constant score (0 to 100 scale); this is neither a statistically nor clinically significant difference.

The results are subgrouped by types of surgical interventions (plate fixation versus intramedullary fixation) for exploratory purposes. The test for subgroup differences does not support a difference between the two surgical interventions (Chi² = 0.43, df = 1 (P = 0.51), I² = 0%).

 
Specific function endpoints

DASH questionnaire (see  Analysis 1.2): Mirzatolooei 2011 found significantly better results in favour of the surgical group, with a mean difference (MD) of -12.70 points (95% CI -15.22 to -10.18); COTS 2007 also reported better results in favour of the surgical group at all time points (P < 0.01). For COTS 2007, outcome data were available graphically, and mean Constant and DASH scores at 12 months, without a measure of variance, were reported in a review by the same authors (McKee 2012); thus, we included the mean scores as reported in the review, extracted the missing standard error from the graphical presentation of data in COTS 2007 and then calculated standard deviations. Pooled data demonstrated a significant reduction in disability in favour of surgery (MD -7.46 points, 95% CI -12.54 to -2.39 points, 0 to 100-point scale) at follow-up of one year or more. The magnitude of the difference was less than 10 points, which is not considered a clinically relevant difference (Gummesson 2003; Hudak 1996).

Constant score (see  Analysis 1.3): The pooled analysis showed a significant improvement in function in favour of surgical intervention (MD 4.87 points (95% CI 2.03 to 7.71, 0 to 100 scale) at follow-up of one year or more. Although substantial heterogeneity was noted (I² = 72%), three of four trials that assessed this outcome reported significant differences favouring surgery.

UCLA score (see  Analysis 1.4): A single trial (Figueiredo 2008) found no significant difference between the two intervention groups in one trial (MD 2.10 points, 95% CI -0.70 to -4.90).

SANE score and L’Insalata score (see  Analysis 1.5 and  Analysis 1.6): A single trial (Judd 2009) found better functional results at short-term follow-up in the surgical group and at long-term follow-up in the conservative group.

 

Pain

Two trials reported on pain. Data could not be extracted from Koch 2008, which reported significantly better short-term pain outcomes in the surgical group (mean VAS on days 5, 19 and 33 was 3.9, 2.9 and 1.6 cm for the surgery group and 5.1, 4.0 and 2.1 cm for the conservatively treated group; reported P < 0.05).

Virtanen 2012a found no statistically significant differences between the two groups at three weeks (MD -6.00 mm, 95% CI -14.34 to 2.34), six weeks (MD 0.00 mm, 95% CI -9.85 to 9.85), three months (MD 4.00 mm, 95% CI -2.76 to 10.76) or one year (MD -4.00 mm, 95% CI -11.65 to 3.65) (see  Analysis 1.7).

 

Treatment failure (primary outcome)

The difference in overall treatment failure was marginally in favour of the surgical group (9/232 versus 24/205; risk ratio (RR) 0.38, 95% CI 0.15 to 0.99) (see  Analysis 1.8).The most common cause of treatment failure in the conservatively managed group was symptomatic non-union, and the most common cause in the surgically managed group was early mechanical failure. Most of the cases of symptomatic malunion (9 out of 11) were reported in one trial (COTS 2007).

Data from Chen 2011 on failure of treatment were reported incompletely; therefore the results of this trial were not entered into the meta-analysis.

When results are subgrouped by types of surgical interventions (plate fixation versus intramedullary fixation) for exploratory purposes, the test for subgroup differences did not show a difference between the two surgical interventions (Chi² = 0.05, df = 1 (P = 0.83), I² = 0%) (see  Analysis 1.9).

 

Other treatment failure (secondary outcome)

When the random-effects model was used to pool results from seven included trials (COTS 2007; Figueiredo 2008; Judd 2009; Koch 2008; Mirzatolooei 2011; Smekal 2009; Virtanen 2012a), no statistically significant difference was identified between the two groups in overall cosmetic problems (RR 1.16, 95% CI 0.34 to 4.01). The pooled results, however, were highly heterogeneous (I² = 74%). Deformity and/or asymmetry was most frequent in the conservative group and hardware irritation in the surgical group (see  Analysis 1.10).

Although pooled data from Mirzatolooei 2011 and Virtanen 2012a showed no difference between groups for asymptomatic non-union, pooled data from these two trials showed that asymptomatic malunion was significantly more common after conservative treatment (4/52 versus 21/49; RR 0.19, 95% CI 0.08 to 0.47) (see  Analysis 1.11 and  Analysis 1.12).

 

Adverse events

Although no significant differences between groups were observed in the pooled results for adverse events from seven included trials (COTS 2007; Figueiredo 2008; Judd 2009; Koch 2008; Mirzatolooei 2011; Smekal 2009; Virtanen 2012a), substantial statistical heterogeneity was noted (I² = 82%) (53/232 versus 30/205; RR 1.28, 95% CI 0.28 to 5.82; see  Analysis 1.13).

Separate analyses by types of adverse events showed that infection and/or dehiscence occurred only in the surgical group (10/117 versus 0/101; RR 6.11, 95% CI 1.10 to 33.84), as did hardware irritation requiring removal (14/173 versus 0/156; RR 5.75, 95% CI 1.53 to 21.65). Skin and nerve problems were also more common after surgical treatment, although these results were not statistically significant (21/147 versus 3/131; RR 2.80, 95% CI 0.29 to 29.98). Conversely, stiffness or restriction of shoulder movement occurred more frequently in the conservatively treated group (5/85 versus 24/73; RR 0.20, 95% CI 0.09 to 0.46). Data from two trials showed no between-group differences in the incidence of refracture (RR 0.96, 95% CI 0.18 to 5.03).

Data from Chen 2011 on adverse events were reported incompletely; therefore, the results of this trial were not entered into the meta-analysis.

When the results were subgrouped by type of surgical intervention (plate fixation versus intramedullary fixation) for exploratory purposes, the test for subgroup differences did not show a difference between the two surgical interventions (Chi² = 0.00, df = 1 (P = 0.95), I² = 0%) (see  Analysis 1.14).

 

Health-related quality of life

No data were available for this outcome.

 

Return to previous activities

Data from single trials found significantly better results in favour of the surgical group with respect to time to return to sport activities (Koch 2008) (MD -6.40 days, 95% CI -12.75 to -0.05) and numbers of participants who returned to sport activities after two months (Figueiredo 2008) (RR 1.47, 95% CI 1.03 to 2.09) (see  Analysis 1.15 and  Analysis 1.16).

 

Sensitivity analyses

We found that overall function at the end of follow-up (one year or more) did not differ between groups in the primary analysis (i.e. including all trials) (SMD 0.46, 95% CI -0.06 to 0.98), nor in the sensitivity analysis, where only trials at low risk of selection bias were included (SMD 0.32, 95% CI -0.13 to 0.76; data not shown). We were unable to assess the effect of including trials at high risk of detection bias, as all trials in the meta-analysis failed to blind the outcome assessor.

We also performed a sensitivity analysis to investigate the effects of missing data on overall treatment failure. In the worst-case scenario, we found a significant difference in favour of surgical intervention (RR 0.35, 95% CI 0.23 to 0.54); for the best-case scenario, no statistically significant difference between groups was noted, although results still tended to favour surgery (RR 0.46, 95% CI 0.17 to 1.25).

Given that all included trials were of comparable size, with the exception of the slightly larger COTS 2007 trial, we could not test for small sample bias. We also were unable to assess the effect of including trials of participants with a history of shoulder injury, because of inadequate reporting of this information in the trials.

 

Discussion

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Summary of main results

We included eight trials involving 555 participants that assessed the effectiveness of surgical interventions compared with conservative interventions for treating people with middle third clavicle fracture. Four studies compared plate fixation with wearing a sling, and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage.

Evidence was not available for all important outcomes from all trials, and trial quality overall was low.

Low-quality evidence from included trials indicated that compared with conservative treatment, surgery to treat clavicle fracture may not result in a significant improvement in upper arm function, may not improve pain or may not reduce the incidence of treatment failure resulting in non-routine surgery (see  Summary of findings for the main comparison). No evidence indicated whether surgery has benefits in terms of quality of life, and we are uncertain of the effect of surgery on cosmetic outcome because of the very low quality of evidence available from seven trials (see  Summary of findings for the main comparison). Conservative treatment reduces the risk of infection and secondary surgery due to hardware complications, but we are uncertain of the estimate of the effect and its precision because of the low quality of the evidence.

 

Overall completeness and applicability of evidence

We included only randomised controlled trials in this review, which resulted in the inclusion of eight trials with 555 participants. All eight included trials assessed only adults with displaced or angulated middle third clavicle fractures, meaning that we were unable to perform subgroup analyses by age or type of fracture. In addition, the included trials did not present outcome data to allow subgroup analysis based on timing of surgery.

All trials failed to measure all outcomes of importance; notably pain was measured in only two trials, one of which provided data for long-term pain (see  Summary of findings for the main comparison).

One limitation of our review is that overall treatment failure is dominated by the results of COTS 2007 (conservative group events: 16/24 = 67%). Our findings should be interpreted with caution because malunions (most frequent in COTS 2007) are usually asymptomatic or are associated with mild symptoms with no need for other types of treatment.

 

Quality of the evidence

The evidence was of low quality overall as the result of methodological flaws including lack of adequate allocation concealment in the majority of trials and failure to blind the outcome assessor in all trials. In addition, included randomised controlled trials (RCTs) did not meet best methodological quality, and no trials reported data on the standards of the CONSORT statement (Moher 2001). Evidence was also hampered by inconsistency across trials in the direction of effect for upper limb function and cosmetic outcome, and by imprecision due to the small number of adverse events measured across trials.

Consequently, the quantitative results of this review should be interpreted with caution and viewed, at this stage, as requiring confirmation by evidence from trials of good methodological quality.

 

Potential biases in the review process

This review was planned and conducted in accordance with criteria and methods set out in a published protocol. We believe that our search strategy was comprehensive with no language restrictions applied, and it has been maintained properly and regularly updated by the contact author (ML). It has included handsearching of conference proceedings and searches for ongoing and recently completed trials. However, it is possible that we have missed some potentially eligible studies. We tried to contact authors of all included trials, but only the authors of one trial provided data. We obtained standard deviations of DASH and Constant scores through personal contact with the authors of one trial (Mirzatolooei 2011).

Currently, a small number of specific validated scores can be used to assess shoulder function. When pooling results from trials that included more than one measure of function, for the purpose of pooling data for the summary of findings, we decided to choose the Constant score as the default because it is more specific for shoulder function than the DASH questionnaire score; and, when compared with the UCLA, SANE and L'Insalata scores, the Constant score is most commonly used in the literature.

 

Agreements and disagreements with other studies or reviews

We found four published systematic reviews that approached the comparison between surgical versus conservative interventions to treat middle third clavicle fracture in adults (Duan 2011; McKee 2012; Virtanen 2012b; Zlowodzki 2005). Three systematic reviews (Duan 2011; Virtanen 2012b; Zlowodzki 2005) included randomised and non-randomised clinical trials, and another systematic review (McKee 2012) restricted the results to RCTs only. The results of our review are consistent with the results of the four non-Cochrane systematic reviews; however, our conclusions differ from those of the other published reviews.

Zlowodzki 2005 assessed all types of comparison treatments for clavicle fracture; the authors identified and included 22 studies (RCTs and non-RCTs). The results on surgical versus conservative interventions were based on pooled data of non-randomised, non-comparative trials and two RCTs with methodological limitations. The authors concluded that a relative risk reduction of 57% for non-union can be achieved when a plate is used rather than conservative intervention, and a relative risk reduction of 72% for non-union can be achieved when intramedullary fixation is used compared with conservative intervention.

Duan 2011 summarised results based on 211 participants of one RCT (COTS 2007) and one conference proceeding (Smith 2001). The authors concluded that surgical intervention resulted in lower incidence of non-union and fewer neurological symptoms compared with conservative treatment. Participants treated by surgical intervention showed improved satisfaction with appearance when compared with participants treated by conservative interventions.

Virtanen 2012b included the results of 13 trials (n = 1190), amongst them six trials that compared surgical versus conservative interventions. The authors interpreted that participants treated surgically derived slight benefit in improving function and less disability than those treated conservatively at short follow-up. However, effectiveness was reduced at long-term follow-up (after six months of treatment).

McKee 2012 systematically assessed the effects of surgical versus conservative interventions for treating middle third clavicle fracture. Their results, based on data from six RCTs, show that surgical treatment provided significantly lower rates of non-union and symptomatic malunion and an earlier functional return compared with conservative treatment. The authors also reported significantly better functional results at long-term follow-up in favour of surgical interventions compared with conservative treatments. Our results were based on eight different trials; we analysed only published data, and McKee 2012 did not include three RCTs (Chen 2011; Figueiredo 2008 and Mirzatolooei 2011).

Our conclusions contrasted with those of the other published reviews because we restricted our results to data from RCTs, extracted the data from included trials in accordance with our pre-established endpoints and developed sensitivity analyses of our results. In addition, our risk of bias is less favourable than that of McKee 2012, as the authors used a scale to assess trial quality. Scales are not recommended because they provide unreliable assessments of validity (Juni 1999).

 

Authors' conclusions

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

 

Implications for practice

Overall, limited evidence is available from randomised controlled trials on the relative effectiveness of surgical versus conservative treatment for acute middle third clavicle fracture. Based on evidence from eight trials with high risk of bias, this review provided some low-quality evidence that surgical interventions may not result in significant improvement in upper arm function. Until conclusive evidence becomes available, treatment options must be chosen on an individual patient basis, with careful consideration of the relative benefits and harms of each intervention and patient preferences.

 
Implications for research

The addition of evidence in future updates of this review from the eight ongoing trials, identified from trial registries, should help to inform on the role of surgical intervention in the management of middle third clavicle fracture. These and all future trials should meet CONSORT criteria for the design and reporting of non-pharmacological studies (Boutron 2008). An appraisal of the need for further randomised trials should be deferred until it becomes clearer whether more are warranted as the evidence accumulates. Meanwhile, in part as preparation for future trials of treatment interventions for these fractures, research is needed to identify or develop and then validate condition-specific patient-reported outcome measures of function and satisfaction with outcome. In addition to providing a focus on patient-reported measures of function and satisfaction, at minimum, all future trials should collect pain outcomes, adverse events and cost outcomes. Systematic data collection at the short, medium and long term after treatment (e.g. during the first month, six months and two years) is essential.

 

Acknowledgements

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

We would like to thank Lindsey Elstub and Joanne Elliott for their assistance in preparing the protocol and review. We thank the following for helpful feedback and comments at editorial review: Bill Gillespie, Helen Handoll, David Ring, Yemisi Takwoingi, Haris Vasiliadis and Janet Wale.

 

Data and analyses

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
Download statistical data

 
Comparison 1. Surgical versus conservative interventions

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Function (overall at the end of follow-up - one year or more)7429Std. Mean Difference (IV, Random, 95% CI)0.46 [-0.06, 0.98]

    1.1 Plate fixation versus conservative intervention
4252Std. Mean Difference (IV, Random, 95% CI)0.63 [0.08, 1.19]

    1.2 Intramedullary fixation versus conservative intervention
3177Std. Mean Difference (IV, Random, 95% CI)0.22 [-0.86, 1.31]

 2 DASH questionnaire (at the end of follow-up - one year or more)4272Mean Difference (IV, Random, 95% CI)-7.46 [-12.54, -2.39]

 3 Constant score (at the end of follow-up - one year or more)5332Mean Difference (IV, Random, 95% CI)4.87 [2.03, 7.71]

 4 UCLA score (at the end of follow-up - one year or more)1Mean Difference (IV, Random, 95% CI)Totals not selected

 5 SANE score1Mean Difference (IV, Random, 95% CI)Totals not selected

    5.1 At three weeks
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    5.2 At six months
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    5.3 At one year
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 6 L’Insalata score1Mean Difference (IV, Random, 95% CI)Totals not selected

    6.1 At three weeks
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    6.2 At six months
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    6.3 At one year
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 7 Pain (measured by VAS: 0 to 100 mm (worst score))1Mean Difference (IV, Random, 95% CI)Totals not selected

    7.1 At 3 weeks
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    7.2 At 6 weeks
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    7.3 At 3 months
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    7.4 At 1 year
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 8 Treatment failure (participants who have a non-routine secondary surgical intervention)7Risk Ratio (M-H, Random, 95% CI)Subtotals only

    8.1 Symptomatic non-union
4268Risk Ratio (M-H, Random, 95% CI)0.39 [0.13, 1.14]

    8.2 Symptomatic malunion
2171Risk Ratio (M-H, Random, 95% CI)0.09 [0.01, 0.68]

    8.3 Early mechanical failure
3211Risk Ratio (M-H, Random, 95% CI)2.95 [0.49, 17.70]

    8.4 Symptoms of brachial plexus irritation
151Risk Ratio (M-H, Random, 95% CI)0.32 [0.01, 7.53]

    8.5 Overall treatment failure
7437Risk Ratio (M-H, Random, 95% CI)0.38 [0.15, 0.99]

 9 Overall treatment failure - subgrouped by type of surgery7437Risk Ratio (M-H, Random, 95% CI)0.38 [0.15, 0.99]

    9.1 Plate fixation versus conservative intervention
4252Risk Ratio (M-H, Random, 95% CI)0.39 [0.07, 2.20]

    9.2 Intramedullary fixation versus conservative intervention
3185Risk Ratio (M-H, Random, 95% CI)0.50 [0.13, 1.92]

 10 Cosmetic result7Risk Ratio (M-H, Random, 95% CI)Subtotals only

    10.1 Deformity and/or asymmetry
4269Risk Ratio (M-H, Random, 95% CI)0.05 [0.01, 0.20]

    10.2 Hardware irritation and/or prominence
5329Risk Ratio (M-H, Random, 95% CI)11.26 [3.13, 40.49]

    10.3 Unsightly scar
3201Risk Ratio (M-H, Random, 95% CI)4.97 [0.91, 27.14]

    10.4 Total of cosmetic problems
7437Risk Ratio (M-H, Random, 95% CI)1.16 [0.34, 4.01]

 11 Asymptomatic non-union2101Risk Ratio (M-H, Random, 95% CI)0.27 [0.02, 3.54]

 12 Asymptomatic malunion2101Risk Ratio (M-H, Random, 95% CI)0.19 [0.08, 0.47]

 13 Adverse events7Risk Ratio (M-H, Random, 95% CI)Subtotals only

    13.1 Infection and/or dehiscence
3218Risk Ratio (M-H, Random, 95% CI)6.11 [1.10, 33.84]

    13.2 Hardware irritation requiring removal
5329Risk Ratio (M-H, Random, 95% CI)5.75 [1.53, 21.65]

    13.3 Skin and nerve problems (incisional numbness)
4278Risk Ratio (M-H, Random, 95% CI)2.80 [0.29, 26.98]

    13.4 Stiffness/restricted of range of shoulder movement
3158Risk Ratio (M-H, Random, 95% CI)0.20 [0.09, 0.46]

    13.5 Refracture
2108Risk Ratio (M-H, Random, 95% CI)0.96 [0.18, 5.03]

    13.6 Total of adverse events
7437Risk Ratio (M-H, Random, 95% CI)1.28 [0.28, 5.82]

 14 Adverse events - subgrouped by type of surgery7437Risk Ratio (M-H, Random, 95% CI)1.28 [0.28, 5.82]

    14.1 Plate fixation versus conservative intervention
4252Risk Ratio (M-H, Random, 95% CI)1.36 [0.12, 15.79]

    14.2 Intramedullary fixation versus conservative intervention
3185Risk Ratio (M-H, Random, 95% CI)1.23 [0.13, 11.87]

 15 Number of patients return to sport activities after two months1Risk Ratio (M-H, Random, 95% CI)Totals not selected

 16 Time to return to previous activities1Mean Difference (IV, Random, 95% CI)Totals not selected

 

Appendices

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Appendix 1. Search strategies

 

MEDLINE (PubMed)

(Clavicle [mh] OR clavic* [tw] OR collarbone [tw]) AND (Fracture Healing [mh] OR Fracture Fixation [mh] OR Fractures, Bone [mh] OR fracture* [tw]) AND (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animals [mh] NOT human [mh])) (119)

 

The Cochrane Library (Wiley Online Library)

#1 MeSH descriptor: [Clavicle] this term only  (62) 
#2 (clavic* or collarbone):ti,ab,kw  (134)    
#3  #1 or #2  (134)
#4 MeSH descriptor: [Fracture Healing] this term only  (330)
#5 MeSH descriptor: [Fracture Fixation] explode all trees  (1002)
#6 MeSH descriptor: [Fractures, Bone] explode all trees  (3419) 
#7 (fracture*):ti,ab,kw   (7155)
#8  #4 or #5 or #6 or#7  (1142)
#9  #3 and #8  (28)

 

EMBASE (OVID Online)

1    Clavicle/ (4128)
2    (clavic$ or collarbone).tw. (7488)
3    or/1-2 (8857)
4    exp Fracture Healing/ or exp fracture treatment/ or exp Fracture/ (203510)
5    fracture$.tw. (180923)
6    or/4-5 (255100)
7    and/3,6 (2650)
8    Clinical trial/ (874175)
9   Randomized controlled trial/ (333315)
10  Randomization/ (60094)
11  Single blind procedure/ (16701)
12  Double blind procedure/ (112042)
13  Crossover procedure/ (35613)
14  Placebo/ (209015)
15  Randomi?ed controlled trial$.tw. (81337)
16  Rct.tw. (10501)
17  Random allocation.tw. (1189)
18  Randomly allocated.tw. (17995)
19  Allocated randomly.tw. (1850)
20  (allocated adj2 random).tw. (713)
21  Single blind$.tw. (12817)
22  Double blind$.tw. (132382)
23  ((treble or triple) adj blind$).tw. (289)
24  Placebo$.tw. (182140)
25  Prospective study/ (219941)
26  or/8-25 (1291791)
27  Case study/ (17858)
28  Case report.tw. (235320)
29  Abstract report/ or letter/ (851431)
30  or/27-29 (1099767)
31  26 not 30 (1256157)
32  limit 31 to human (1150408)
33  and/7,32 (150)

 

LILACS (Bireme)

Mh clavicle OR Tw clavic$ OR Tw collarbone [Words] 

and 

Mh fracture healing OR Mh fracture fixation OR Mh fractures OR Tw fracture$ [Words] 

and 

((Pt randomized controlled trial OR Pt controlled clinical trial OR Mh randomized controlled trials OR Mh random allocation OR Mh double-blind method OR Mh single-blind method) AND NOT (Ct animals AND NOT (Ct human and Ct animal)) OR (Pt clinical trial OR Ex E05.318.760.535$ OR (Tw clin$ AND (Tw trial$ OR Tw ensa$ OR Tw estud$ OR Tw experim$ OR Tw investiga$)) OR ((Tw singl$ OR Tw simple$ OR Tw doubl$ OR Tw doble$ OR Tw duplo$ OR Tw trebl$ OR Tw trip$) AND (Tw blind$ OR Tw cego$ OR Tw ciego$ OR Tw mask$ OR Tw mascar$)) OR Mh placebos OR Tw placebo$ OR (Tw random$ OR Tw randon$ OR Tw casual$ OR Tw acaso$ OR Tw azar OR Tw aleator$) OR Mh research design) AND NOT (Ct animals AND NOT (Ct human and Ct animals)) OR (Ct comparative study OR Ex E05.337$ OR Mh follow-up studies OR Mh prospective studies OR Tw control$ OR Tw prospectiv$ OR Tw volunt$ OR Tw volunteer$) AND NOT (Ct animals AND NOT (Ct human and Ct animals))) [Words]  (17)

 

Feedback

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Feedback submitted 11 March 2014

 

Summary

Dear Mr Lenza

I read your review ''Surgical versus conservative interventions for treating fractures of the middle third of the clavicle'' with interest. The review states that there is no statistically significant difference in outcomes between surgical and conservative interventions. However, the review does demonstrate a statistically significant difference between plate fixation and conservative management.

Analysis 1.1 demonstrates that there is no statistically significant difference where the analysis compares all types of surgical intervention with conservative treatment. This would seem to support the conclusion of the review. However, when the surgical interventions are subgrouped, so that intramedullary fixation and plate fixation are separately compared with conservative treatment, there is a significant difference between plate fixation and conservative treatment in favour of plate fixation (SMD is 0.63; 95% CI 0.08 to 1.19; P = 0.03). This finding is not fully reported in the review itself.

In my opinion this is a relevant finding because it shows that one of the surgical interventions (plate fixation) gives a significantly better functional outcome at one year compared with conservative treatment.

Shanti Kersten, Medical Student

 

Reply

Thank you for your interest in our review. We agree with you that our result for the endpoint function or disability at the end of follow-up (one year) was statistically significantly better in patients who underwent plate fixation compared with conservative treatment (SMD 0.63, 95% CI 0.08 to 1.19; P = 0.03). However, the test for subgroup differences does not support a difference between the two types of surgical interventions (Chi2 = 0.43; df = 1; P = 0.51; I2 = 0%).

Additionally, though the result for plate fixation is statistically significant, it, like the overall result, is unlikely to correspond to a clinically relevant effect (the findings translate to 4.4 points, 95% CI 0.6 to 8.3 points on the Constant score). Ten points has been reported to be the minimal clinically important difference on the Constant score (Kukkonen 2013; Roy 2010).

While our main focus is on comparing the effects of surgical versus conservative interventions, we anticipate that there will be more evidence to inform subgroup analysis by implant type when we update this review.

Mario Lenza, Contact Author

 

Contributors

Mario Lenza, Contact Author
Xavier Griffin, Feedback Editor for the Bone, Joint and Muscle Group
Helen Handoll, Co-ordinating Editor for the Bone, Joint and Muscle Group

 

What's new

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

Last assessed as up-to-date: 10 March 2013.


DateEventDescription

31 March 2014Feedback has been incorporatedThis review incorporates a response to feedback sent 11 March 2014. There was no change to the review.



 

Contributions of authors

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

All authors contributed to the review. ML, RJ and RB drafted the review and all authors provided comments and approved the final version. The guarantor of this review is Mario Lenza.

 

Declarations of interest

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

None known.

 

Sources of support

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Internal sources

  • Universidade Federal de São Paulo, Brazil.
  • Monash University, Australia.

 

External sources

  • No sources of support supplied

 

Differences between protocol and review

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Feedback
  13. What's new
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

  • When trials included more than one measure of function, for the purpose of pooling data for the summary of findings we decided to choose the Constant score because it is more specific for the shoulder than the DASH questionnaire; and, when compared with the UCLA, SANE and L'Insalata scores, the Constant score is the most commonly used in the literature.
  • For future updates, we will consider assessing inappropriate influence of funders under ‘Other bias’ of The Cochrane Collaboration's 'Risk of bias' tool.

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. AbstractRésumé
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. Feedback
  14. What's new
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
Chen 2011 {published data only}
  • Chen QY, Kou DQ, Cheng XJ, Zhang W, Wang W, Lin ZQ, et al. Intramedullary nailing of clavicular midshaft fractures in adults using titanium elastic nail. Chinese Journal of Traumatology 2011;14(5):269-76.
COTS 2007 {published and unpublished data}
  • Altamimi SA, McKee MD, Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. Surgical technique. Journal of Bone & Joint Surgery - American Volume 2008;90(Suppl 2, Pt 1):1-8.
  • Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. Journal of Bone & Joint Surgery - American Volume 2007;89(1):1-10.
  • Hall J, McKee MD, Wild LM, Schemitsch EH, Jones AL, Schmidt AH. A multicenter PRCT of non-operative versus operative treatment of midshaft clavicle fractures [abstract]. American Academy of Orthopaedic Surgeons Annual Meeting. 2006 March 22-26;Chicago (IL).
  • McKee MD. personal communication March 2012.
  • Neuhaus V, Ring D. Effect of different statistical methods on union or time to union in a published study about clavicular fractures. Journal of Shoulder and Elbow Surgery 2012;Apr 21.
  • Pearson AM, Tosteson AN, Koval KJ, McKee MD, Cantu RV, Bell JE, et al. Is surgery for displaced, midshaft clavicle fractures in adults cost-effective? Results based on a multicenter randomized, controlled trial. Journal of Orthopaedic Trauma 2010;24(7):426-33.
  • Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function plateaus by one year in patients with surgically treated displaced midshaft clavicle fractures. Clinical Orthopaedics and Related Research 2011;469(12):3351-5.
Figueiredo 2008 {published data only}
  • Figueiredo EA, Neves EJ, Yoshizawa Júnior H, Dall’Ara Neto A, Nascimento LFC, Faria GHM, et al. Prospective randomized study comparing surgical treatment using anterior plate to non-surgical treatment of midshaft clavicle fractures [Estudo prospectivo randomizado comparativo entre os tratamentos cirúrgico utilizando placa anterior e o não cirúrgico das fraturas do terço médio da clavícula]. Revista Brasileira de Ortopedia 2008;43(10):419-25.
Judd 2009 {published and unpublished data}
  • Judd DB, Pallis MP, Smith E, Bottoni CR. Acute operative stabilization versus nonoperative management of clavicle fractures. American Journal of Orthopedics (Belle Mead, N.J.) 2009;38(7):341-5.
  • Judd DB, Pallis MP, Smith E, Bottoni CR. Intramedullary fixation versus nonoperative treatment for mid-shaft clavicle fractures: Paper #034. Proceedings of the 72nd Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). 2005 23-27 February; Washington DC.
Koch 2008 {published data only}
  • Koch HJ, Raschka C, Tonus C, Witzel K. The intramedullary osteosynthesis of the diaphyseal fracture of the clavicle compared to conservative treatment [Die intramedulläre osteosynthese der klavikuladiaphysenfraktur im vergleich zur konservativen therapie]. Deutsche Zeitschrift für Sportmedizin 2008;59(4):91-4.
  • Witzel K. Intramedullary osteosynthesis in fractures of the mid-third of the clavicle in sports traumatology [Intramedulläre osteosynthese bei schaftfrakturen der klavikula in der sporttraumatologie]. Zeitschrift für Orthopädie und Unfallchirurgie 2007;145(5):639-42.
Mirzatolooei 2011 {published data only}
  • Mirzatolooei F. Comparison between operative and nonoperative treatment methods in the management of comminuted fractures of the clavicle. Acta Orthopaedica et Traumatologica Turcica 2011;45(1):34-40.
Smekal 2009 {published data only}
  • Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures - a randomized, controlled, clinical trial. Journal of Orthopaedic Trauma 2009;23(2):106-12.
Virtanen 2012a {published and unpublished data}
  • Chutkan NB. Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: a randomized clinical trial. Orthopedics 2012;35(11):961-2.
  • Virtanen KJ, Paavola MP, Remes VM, Pajarinen J, Savolainen V, Bjorkenheim JM. Nonoperative versus operative treatment of midshaft clavicle fractures: a randomized controlled trial (Paper no 331). 75th Annual Meeting of the an Academy of Orthopaedic Surgeons; 2010 Mar 9-12;New Orleans (LA).
  • Virtanen KJ, Remes V, Pajarinen J, Savolainen V, Björkenheim JM, Paavola M. Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: a randomized clinical trial. Journal of Bone & Joint Surgery - American Volume 2012;94(17):1546-53.
  • Virtanen KJ, Remes V, Pajarinen J, Savolainen V, Björkenheim JM, Paavola MP. Study comparing plate stabilization to conservative treatment in midshaft clavicle fractures. ClinicalTrials.gov at: http://clinicaltrials.gov/ct2/show/NCT01199653 2010 (accessed 04 May 2012).

References to studies excluded from this review

  1. Top of page
  2. AbstractRésumé
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. Feedback
  14. What's new
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
Bernstein 2007 {published data only}
  • Bernstein J. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. Journal of Bone & Joint Surgery - American Volume 2007;89(8):1866-7.
Bohme 2011 {published data only}
  • Bohme J, Bonk A, Bacher GO, Wilharm A, Hoffmann R, Josten C. Current treatment concepts for mid-shaft fractures of the clavicle - results of a prospective multicentre study [Aktuelle behandlungskonzepte der klavikulaschaftfraktur - Ergebnisse einer prospektiven multicenterstudie]. Zeitschrift für Orthopädie und Unfallchirurgie 2011;149(1):68-76.
Bravo 2009 {published data only}
Jubel 2002 {published data only}
  • Jubel A, Andermahr J, Faymonville C, Binnebosel M, Prokop A, Rehm KE. Reconstruction of shoulder-girdle symmetry after midclavicular fractures. Stable, elastic intramedullary pinning versus rucksack bandage [Wiederherstellung der symmetrie des schultergürtels bei klavikulafrakturen elastisch stabile intramedulläre osteosynthese vs. rucksackverband]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 2002;73(10):978-81.
Jubel 2005 {published data only}
  • Jubel A, Andermahr J, Prokop A, Lee JI, Schiffer G, Rehm KE. Treatment of mid-clavicular fractures in adults. Early results after rucksack bandage or elastic stable intramedullary nailing [Die Behandlung der diaphysären Kla vikulafraktur Ver gleich der Früher gebnisse nach Rucksackverband und elastisch stabiler intramedullärer Nagelung]. Der Unfallchirurg 2005;108(9):707-14.
Kulshrestha 2011 {published data only}
  • Kulshrestha V, Roy T, Audige L. Operative versus nonoperative management of displaced midshaft clavicle fractures: a prospective cohort study. Journal of Orthopaedic Trauma 2011;25(1):31-8.
McKee 2010 {published data only}
NCT01311219 {unpublished data only}
  • White RA. Study comparing intramedullary nailing, plate fixation, and non-operative treatment of clavicle fractures . WHO International Clinical Trial Registry at: http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01311219 (accessed 04 May 2012).
Simon 2010 {published data only}
Smekal 2011 {published data only}
  • 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.

References to studies awaiting assessment

  1. Top of page
  2. AbstractRésumé
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. Feedback
  14. What's new
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
ISRCTN00825817 {unpublished data only}
  • Bale S. Open reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures. http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN00825817 (accessed 07 May 2012).
ISRCTN57483251 {unpublished data only}
  • Khan SA. Assessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment. http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN57483251 (accessed 07 May 2012).
Smith 2001 {published data only}
  • Smith CA, Rudd J, Crosby LA. Results of operative versus nonoperative treatment for 100% displaced midshaft clavicle fractures: a prospective randomized clinical trial. Read at the 16th Annual Open Meeting of the American Shoulder and Elbow Surgeons. 2000 Mar 18; Orlando, FL. Paper no 31.
  • Smith CA, Rudd JN, Crosby LA. Results of operative versus nonoperative treatment for 100% displaced mid-shaft clavicle fractures: a prospective randomized clinical trial [abstract]. American Academy of Orthopaedic Surgeons 68th Annual Meeting. 2001 Feb 27-Mar 4;San Francisco (CA).

References to ongoing studies

  1. Top of page
  2. AbstractRésumé
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. Feedback
  14. What's new
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
ACTRN12610000948099 {unpublished data only}
  • Clitherow HS. Displaced midshaft clavicle fractures: conservative management vs plate fixation. A multi-centre randomised controlled trial. http://apps.who.int/trialsearch/Trial.aspx?TrialID=ACTRN12610000948099 (assessed 04 May 2012).
ISRCTN66495030 {unpublished data only}
  • da Costa AR. Treatment of midshaft clavicle fractures: plate fixation versus figure-of-eight bandage: Randomised controlled clinical trial. http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN66495030 (assessed 06 May 2012).
Longo 2011 {published data only}
  • Ahrens P. Clavicle Trial - Randomised controlled multicentre study of conservative management versus open reduction and internal fixation of mid-shaft clavicle fractures. UK Clinical Research Network: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=8665 (accessed 18 February 2013).
  • Longo UG, Banerjee S, Barber J, Chambler A, Cobiella C, Corbett S, et al. Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults--the Clavicle Trial: study protocol for a multicentre randomized controlled trial. Trials 2011;12:57.
NCT00590850 {unpublished data only}
  • Jeray KJ. A multicenter, prospective, randomized trial of non-operative versus operative treatment for high-energy midshaft clavicle fractures. http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT00590850 (assessed 07 May 2012).
NCT00642265 {unpublished data only}
  • 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 . http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT00642265 (assessed 06 May 2012).
NCT01078480 {unpublished data only}
  • Jensen CM. Conservative treatment versus plate osteosynthesis using angular stabile screws and precontoured plates in displaced midshaft clavicular fractures. A prospective randomized multicenter study. http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01078480 (assessed 06 May 2012).
NCT01483482 {unpublished data only}
  • Ban I. Treatment of displaced, midshaft clavicle fractures. Sling or plate?. http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01483482 (assessed 04 May 2012).
Stegeman 2011 {published and unpublished data}
  • 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. http://apps.who.int/trialsearch/Trial.aspx?TrialID=NTR2399 (assessed 04 May 2012).
  • Stegeman SA, de Jong M, Sier CF, Krijnen P, Duijff JW, van Thiel TP, et al. Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial. BMC Musculoskeletal Disorders 2011;12:196.

Additional references

  1. Top of page
  2. AbstractRésumé
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. Feedback
  14. What's new
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
Allman 1967
  • Allman FL Jr. Fractures and ligamentous injuries of the clavicle and its articulation. The Journal of Bone and Joint Surgery. American Volume 1967;49(4):774-84.
Altman 2001
  • Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001;134(8):663-94.
Andersen 1987
Begg 1996
  • Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276(8):637-9.
Boehme 1991
  • Boehme D, Curtis RJ Jr, DeHaan JT, Kay SP, Young DC, Rockwood CA Jr. Non-union of fractures of the mid-shaft of the clavicle. Treatment with a modified Hagie intramedullary pin and autogenous bone-grafting. Journal of Bone & Joint Surgery - American Volume 1991;73(8):1219-26.
Boutron 2008
  • Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine 2008;148(4):295-309.
Bradbury 1996
  • Bradbury N, Hutchinson J, Hahn D, Colton CL. Clavicular nonunion. 31/32 healed after plate fixation and bone grafting. Acta Orthopaedica Scandinavica 1996;67(4):367-70.
Canadian 2007
  • Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. Journal of Bone and Joint Surgery. American Volume 2007;89(1):1-10.
Constant 1987
  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clinical Orthopaedics and Related Research 1987;(214):160-4.
Court-Brown 2006
Deeks 2008
  • Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9: Analysing data and undertaking meta-analyses. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration. Available from www.cochrane-handbook.org.
Duan 2011
  • Duan X, Zhong G, Cen S, Huang F, Xiang Z. Plating versus intramedullary pin or conservative treatment for midshaft fracture of clavicle: a meta-analysis of randomized controlled trials. Journal of Shoulder Elbow Surgery 2011;20(6):1008-15.
Ebraheim 1997
Eccleston 2010
Eiff 1997
Gummesson 2003
  • Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskeletal Disorders 2003;4:11.
Hall 2006
  • Hall J, McKee MD, Wild LM, Schemitsch EH, Jones AL, Schmidt AH. A multicenter PRCT of non-operative versus operative treatment of midshaft clavicle fractures [abstract]. American Academy of Orthopaedic Surgeons Annual Meeting;2006 March 22-26;Chicago (IL). 2006.
Higgins 2006
  • Higgins JPT, Green S, editors. Highly sensitive search strategies for identifying reports of randomized controlled trials in MEDLINE. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6 [updated September 2006]; Appendix 5b. http://www.cochrane.org/resources/handbook/hbook.htm (accessed 6th October 2006).
Higgins 2011a
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Higgins 2011b
  • Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Higgins 2011c
  • Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Hill 1997
Hudak 1996
  • Hudak PL, Amadio PC, Bombardier C, Boland A, Fischer T, Flatow EL, et al. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). American Journal of Industrial Medicine 1996;29(6):602-8.
Jeray 2007b
Juni 1999
Jupiter 1987
  • Jupiter JB, Leffert RD. Non-union of the clavicle. Associated complications and surgical management. Journal of Bone and Joint Surgery. American Volume 1987;69(5):753-60.
Kotelnicki 2006
  • Kotelnicki JJ, Bote HO, Mitts KG. The management of clavicle fractures. Journal of the American Academy of Physician Assistants 2006;19(9):50, 53-4, 56.
Kukkonen 2013
  • Kukkonen J, Kauko T, Vahlberg T, Joukainen A, Aärimaa V. Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. Journal of Shoulder Elbow Surgery 2013;22(12):1650-5.
Lazarus 2001
  • Lazarus MD. Fractures of the clavicle. In: Bucholz RW, Heckman JD editor(s). Rockwood & Greens fractures in adults. 5. Philadelphia: Lippincott-Wilkins, 2001:1041-78.
Lenza 2009a
Lenza 2009b
Marti 2003
McKee 2006
  • McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, et al. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. Journal of Bone and Joint Surgery. American Volume 2006;88(1):35-40.
McKee 2012
  • McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: A meta-analysis of randomized clinical trials. Journal of Bone & Joint Surgery - American Volume 2012;94(8):678-84.
Meier 2006
  • Meier C, Grueninger P, Platz A. Elastic stable intramedullary nailing for midclavicular fractures in athletes: indications, technical pitfalls and early results. Acta Orthopaedica Belgica 2006;72(3):269-75.
Moher 2001
  • Moher D, Jones A, Lepage L, CONSORT Group (Consolitdated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001;285(15):1992-5.
Moore 2010
  • Moore RA, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, et al. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain 2010;150(3):386-9.
Mullaji 1994
Muller 1991
  • Muller M, Allgower M, Schneider R, Willenegger H. Manual of internal fixation: techniques recommended by the AO-ASIF Group. 3rd Edition. Berlin: Springer-Verlag, 1991. Manual of internal fixation: techniques recommended by the AO-ASIF Group. 3rd Edition. Berlin: Springer-Verlag, 1991.
Neer 1984
  • Neer C. Fractures of the clavicle. In: Rockwood CA Jr, Green DP editor(s). Fractures in adults. 2nd Edition. Philadelphia: Lippincott Williams & Wilkins, 1984:707-13.
Nordqvist 1994
  • Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clinical Orthopaedics and Related Research 1994;(300):127-32.
Nordqvist 1998
Nowak 2000
Pearson 2010
  • Pearson AM, Tosteson AN, Koval KJ, McKee MD, Cantu RV, Bell JE, et al. Is surgery for displaced, midshaft clavicle fractures in adults cost-effective? Results based on a multicenter randomized, controlled trial. Journal of Orthopaedic Trauma 2010;24(7):426-33.
Postacchini 2002
Robinson 1998
Robinson 2004
  • Robinson CM, Court-Brown CM, McQueen MM, Wakefield AE. Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture. Journal of Bone and Joint Surgery. American Volume 2004;86(7):1359-65.
Roy 2010
  • Roy JS, MacDermid JC, Woodhouse LJ. A systematic review of the psychometric properties of the Constant-Murley score. Journal of Shoulder Elbow Surgery 2010;19(1):157-64.
Schemitsch 2011
  • Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function plateaus by one year in patients with surgically treated displaced midshaft clavicle fractures. Clinical Orthopaedics and Related Research 2011;469(12):3351-5.
Sterne 2008
  • Sterne JAC, Egger M, Moher D (editors). Chapter 10: Addressing reporting biases. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Intervention. Version 5.0.1 (updated September 2008). The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org. Available from www.cochrane-handbook.org.
Virtanen 2012b
Ware 1992
Witzel 2007
  • Witzel K. Intramedullary osteosynthesis in fractures of the mid-third of the clavicle in sports traumatology [Intramedulläre osteosynthese bei schaftfrakturen der klavikula in der sporttraumatologie]. Zeitschrift für Orthopädie und Unfallchirurgie 2007;145(5):639-42.
Yian 2005
Zlowodzki 2005
  • Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. Journal of Orthopaedic Trauma 2005;19(7):504-7.