OrthoEvidence Review: Operative vs nonoperative treatment for displaced clavicle fractures

Study Type: ACE Review
OE Level of Evidence: N/A
Journal Level of Evidence: N/A
Operative Versus Non-Operative Treatments for Displaced Mid-Shaft Clavicle Fractures: An OrthoEvidence Review of Best Evidence
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.
Funding: Sponsor: Conflicts:
Industry funded The Orthopaedic Trauma Association and Zimmer Inc. None disclosed
Funding: Sponsor: Conflicts:
Non-funded None disclosed
Funding: Sponsor: Conflicts:
Non-Industry funded St. Michaels Hospital Orthopaedic Research and Education Fund (to R.C.M.) Other
Funding: Sponsor: Conflicts:
Non-Industry funded Helsinki University Central Hospital research funds Other
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Non-funded Company Employee
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Non-funded None disclosed
Funding: Sponsor: Conflicts:
Not Reported None disclosed
Funding: Sponsor: Conflicts:
Not Reported None disclosed
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?
Report Characteristics: 13 reports including nine randomized trials and four systematic reviews/meta-analyses were identified that evaluated operative versus nonoperative methods (5 studies, 381 patients) and operative versus operative procedures (4 studies, 267 patients) for the treatment of displaced midshaft clavicle fractures. All nine randomized controlled trials (RCTs) published from January 2007 to October 2012. The four reviews or meta-analyses identified evaluated the use of operative and non-operative treatments in clavicle fractures.
Report Selection: The following terms were used to search the OrthoEvidence database: 'clavicle fracture', 'clavicle', and 'clavicular'. The search resulted in the identification of 15 studies (RCTs and meta-analyses) for possible inclusion. Screening using the inclusion criteria led to the exclusion of 6 reports, leaving 9 reports (5 RCTs and 4 systematic reviews/meta-analyses) for inclusion. Moreover, the references of the identified meta-analyses were searched and an additional (4) RCTs were included, leading to a total of 9 RCTs in this review. Five of these studies examined operative vs. nonoperative procedures while 4 studies evaluated operative vs. operative treatment for clavicle fractures.
Outcomes: Outcome measures included union rates (union achieved, malunion, and delayed union), functional outcome (measured with the Constant Shoulder Score and the Disabilities of Arm, Hand and Shoulder score), satisfaction, pain, and other mild complications (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)
Heterogeneity: The I-squared statistic was used to assess heterogeneity when pooling was possible.
Report Details and Scores
Randomization sequence adequately generated Randomization sequence adequately concealed Blinding outcome assessors Blinding of patients Loss to follow-up infrequent Outcomes objective Large enough sample size to ensure balance of outcomes
Canadian Orthopaedic Trauma Society
Virtanen K.
Judd D.
Mirzatolooei F.
Smekal V.
Ferran N.
Assobhi J.
Shen J.
Jiang H.
McKee R.
Ban I
Virtanen K.
Duan X.
Yes Uncertain Not Applicable No
Pooling and Statistical Analysis
Statistical pooling was performed for 4 outcome measures: Nonunion, malunion, delayed union, and other complications. The remaining measures (Constant Shoulder Score, Disabilities of the Arm, Hand and Shoulder, patient satisfaction, and pain) were not reported in a fashion that allowed statistical pooling.
  • 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.
Main Findings
Forest Plot: Nonunion
Forest Plot: Malunion
Forest Plot: Delayed Union
Forest Plot: Other Complications
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.
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.
IOA Member
June 25, 2013
Orthopaedic Surgeon - India
THE TREATMENT OPTION FOR FRACTURE CLAVICLE SHOULD CONSIDER MULTIPLE ASPECTS e g THE VIEWS & AFFORDIBILITY OF A PARTICULAR PATIENT.IF THE PATIENT IS READY TO ACCEPT THE DEFORMITY WITHOUT COMPROMISING THE ULTIMATE FUNCTIONAL RESULT,HE MAY BE TREATED CONSERVATIVELY WITH ACLAVICLE BRACE IN ADDITION TO SLING.BUT IF THE PATIENT"S OCCUPATION DEMANDS A SLEEK COSMETIC APPEARENCE & IF HE CAN AFFORD,HE OR SHE SHOULD BE TREATED BY OPERATIVE TREATMENT.IN VIEW OF APPEARENCE PINNING WOULD BE A BETTER OPTION.
June 28, 2013
Except in a few rare cases with specific indications, surgical treatment of the fracture clavicle is for the text books only
November 10, 2015
In terms of post-operative outcome and complications, the review did not show comparison between different types of fixation, like : infection, union rate, need for removal, revision surgery, post-op pain, migration, blood loss, surgery time.