OrthoEvidence Review: Operative vs nonoperative treatment for displaced clavicle fractures
OrthoEvidence Review: Operative vs nonoperative treatment for displaced clavicle fractures
Operative Versus Non-Operative Treatments for Displaced Mid-Shaft Clavicle Fractures: An OrthoEvidence Review of Best Evidence
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Synopsis
13 ACE reports (4 reviews/ meta-analyses, 9 RCTs) were included from the OrthoEvidence database that compared operative versus nonoperative or operative versus operative treatments for displaced midshaft clavicle fractures. The findings of this review demonstrated that surgical procedures led to a lower rate of nonunion and malunion with better functional outcome when compared to nonoperative treatment. Comparisons of operative treatments indicated that an optimal surgical procedure - between plate fixation, nailing, and pin fixation - could not be determined based on union rates or functional outcome. The results of this review highlighted the need for standardized outcome reporting within the literature to improve comparisons between trials.
Report Details and Scores
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
4/4
Accessing Data
4/4
Analysing Data
3/4
Results
3/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
1/4
Randomization
2/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
3/4
Accessing Data
1/4
Analysing Data
1/4
Results
2/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
4/4
Accessing Data
2/4
Analysing Data
1/4
Results
2/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
3/4
Accessing Data
4/4
Analysing Data
3/4
Results
3/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Randomization
3/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
1/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
2/4
Randomization
1/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Background
Midshaft clavicle fractures are one of the most common types of fractures, accounting for 2 to 5 percent of all total fractures. While this type of fracture can be treated both operatively and nonoperatively, there has been a shift towards operative treatment due to a belief that high rates of nonunion occur when treated conservatively. Furthermore, it remains unclear which surgical procedure provides the best functional outcomes for treating clavicle fractures. This review was conducted to evaluate the current high quality evidence available in order to determine whether operative treatment was more effective in improving union rates and functional outcome when compared to nonoperative methods for patients with displaced midshaft clavicle fractures. Additionally, this review aimed to determine if there was a surgical procedure that was superior to other operative techniques.
What was the principal research question?
Which method - operative or nonoperative treatment - was more effective in the treatment of displaced midshaft clavicle fractures, in terms of union rates and functional outcomes? Additionally, is there a surgical procedure that is superior (between plate fixation, nailing, and pin fixation) for the management of displaced clavicle fractures?
What were the important findings?
- 5 trials reported nonunion outcomes (381 patients). Results significantly favoured the operative treatment with a reduction in the occurrence of non-union (OR = 0.22 [95% CI 0.08-0.66], P = 0.006; l-squared = 0%).
- 4 trials addressed the occurrence of malunion (324 patients). Results demonstrated favourable outcomes for operative treatment (OR = 0.06 [95% CI 0.02-0.19], P < 0.00001; l-squared = 0%).
- 2 studies reported delayed union (163 patients). Pooling of data did not favour either treatment (OR = 0.63 [95% CI 0.04-11.17], P = 0.75; I-squared = 76%).
- 5 studies presented other mild complications (381 patients). Statistical analysis of pooled data indicated a favourable outcome for non-operative treatment (OR = 3.36 [95% CI 1.12-10.17], P = 0.03; I-squared = 61%). The complications included infections, irritation (skin and brachial plexus), refractures, hardware removal, early mechanical failure, complex regional pain syndrome, telescoping, skin desynthesia, partial transient radial nerve palsy, abnormality of the acromioclavicular or sternoclavicular joint and hypertrophic scars.
- 4 studies presented Constant Shoulder Score outcomes. Due to heterogeneity of reporting methods, pooling of data was not applicable. Three out of four (COTS, Mirzatolooei, Smekal et al.) studies reported superior constant scores in the operative group at greater than 1 year follow up (P < 0.05)
- 4 studies reported DASH scores. Due to heterogeneity of reporting methods, pooling of data was not applicable. Three out of four (COTS, Mirzatolooei, Smekal et al.) studies reported superior DASH scores in the operative group at greater than 1 year follow up (P < 0.05)
- 2 studies reported patient satisfaction. COTS reported that patients in the operative group were more satisfied with their shoulder and shoulder appearance at all time points up to 12 months. Mirzatalooei reported patient satisfaction at 12 months: 3 patients were completely satisfied, 2 were partially satisfied, and 21 patients were not satisfied in the operative group. For nonoperative treatment, none were completely satisfied, 18 were partially satisfied, and 6 were not satisfied.
- 2 studies documented pain at 12 months. One study (Mirzatolooei) favoured operative treatment, while the other study (Virtanen et al.) indicated no difference.
- 4 studies compared operative vs. operative treatments; two of the four studies compared plate fixation with pin fixation (Ferran et al.) and plate fixation with nailing (Assobhi). The results revealed that the Constant scores at 12 months were comparable between plate fixation and the other surgical procedures; the same trend was observed for the rate of union achieved.
- Similarly to the recent meta-analysis by Mckee 2012, our review showed similar trends of fewer malunions and nonunions in operative group. This publication also supported a favorable trend towards better Constant and DASH scores with the operative treatment.
- In comparison to other identified meta-analyses, the higher incidences of malunion and nonunion in non-operative treatment were also reported by 3 studies (Ban 2012, Virtanen 2012, and Duan 2011). Additionally, 2 studies (Virtanen 2012 and Ban 2012) indicated better functional DASH and Constant scores with operative treatment.
- A meta-analysis by Duan 2011 supported a greater satisfaction in appearance with operative management.
What should I remember most?
The findings of this review have indicated that the incidence of nonunion and malunion were significantly lower with operative treatment in comparison to nonoperative treatment for displaced midshaft clavicle fractures; however, surgical procedures were associated with higher rates of other, more minor complications. In terms of function, the majority of studies comparing operative versus nonoperative treatments have revealed that both Constant and DASH scores were significantly better with surgical procedures at greater than 1 year follow-up. Whether pain and patient satisfaction favoured one treatment over the other could not be determined conclusively. Lastly, the comparison between plate fixation and other surgical procedures revealed that there was no clear indication of one technique being superior in terms of Constant scores and union rates.
Implications for patient treatment and future research:
The results of this review demonstrate that surgical treatment for displaced midshaft clavicle fractures leads to a higher rate of union and better functional outcomes when compared to nonoperative sling treatments. Moreover, this review was unable to determine the optimal surgical procedure between plate fixation, nailing, and pin fixation. The findings of this review demonstrate the need for standard outcome reporting guidelines within the literature to improve comparisons between trials and indicated the need for further investigation into the best operative technique.
ACE Reports in this review:
Lower rate of malunion or nonunion with operative treatment of displaced clavicle fracture
3D reconstruction plate better than superiorly placed plate for clavicle fracture fixation
Operative treatment of displaced mid-shaft fractures of the clavicle reduces complications
Displaced clavicle fracture: Non-operative treatment leads to increased rate of non-union
Clavicle Fracture: Greater satisfaction and fewer complications with MIS method
Surgical versus conservative treatment of midshaft clavicle fractures
Operative treatment of clavicle fractures improves short-term functional outcomes
Retrograde nailing and plate fixation effective in treating midshaft clavicular fractures
Plating displays similar results to intramedullary pinning for midclavicular fractures
Elastic stable intramedullary nailing superior for simple mid-shaft clavicular fractures
Locked intramedullary fixation and plating for clavicle fractures show similar outcome
ORIF more effective and satisfactory treatment for comminuted clavicle fractures
Operative treatment with Hagie pin for clavicle fractures lead to higher complication rate
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