Abstract
Introduction
Open reduction and internal fixation (ORIF) of displaced midshaft clavicle fractures is associated with higher union rates and earlier functional recovery. However, ORIF with plate fixation is associated with complications including implant irritation and implant failure. Dual plate fixation provides fixation in orthogonal planes, and uses a lower profile fixation technique in comparison to pre-contoured and surgeon-contoured small-fragment locking plates, which may be more prominent. The objective of this study was to conduct a systematic review to summarize outcomes and complications associated with surgical fixation of displaced acute midshaft clavicle fractures with dual plate fixation.
Methods
Using a predetermined study protocol in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, the databases MEDLINE, EMBASE, and CENTRAL were searched from inception to 2020 to identify studies reporting outcomes in acute midshaft clavicle fractures treated with dual plate fixation. All clinical studies which reported on outcomes of dual plating in patients with acute midshaft clavicle fractures were included. Baseline demographics, plate fixation constructs, fracture union rates, implant removal rates, maintenance of reduction, symptomatic implant rates, wound complications, and functional outcomes were extracted. All extracted data were recorded, and descriptive statistics were summarized. Meta-analysis was performed on fracture union rates and implant removal rates using random-effects modeling using Mantel-Haenszel weighting.
Results
Our literature search identified 2226 unique abstracts, of which eight studies met our study inclusion criteria following review. A total of 278 patients made up of 79.8% male with an average age of 36.0 years were included. The overall dual plate implant removal rate was 4.2% with excellent rates of union reported. Moreover, single plate fixation was associated with a 3.9-fold increased implant removal rate compared to dual plate fixation.
Conclusion
Results from this systematic review demonstrate that ORIF of displaced midshaft clavicle fractures using a dual plate fixation technique is a viable option to reduce the incidence of implant removal, without negatively impacting the rate of fracture union.
Level of evidence
Therapeutic Level III.
Keywords: Clavicle fracture, Dual plate fixation, Orthogonal plate fixation, Fracture union, Orthopaedic trauma
1. Introduction
Fractures of the clavicle are common, with an incidence ranging from 21.5 to 22.0 per 100,000.1,2 These injuries occur predominantly in young males and most frequently in the middle third of the bone, with the location accounting for two-thirds of all clavicle fractures.2 Management of displaced midshaft clavicle fractures with open reduction and internal fixation (ORIF) is associated with higher union rates, lower rates of malunion, and earlier functional recovery, as compared to non-operative treatment.3, 4, 5, 6 There has been a nearly 10-fold increase in ORIF of displaced midshaft clavicle fractures reported since the Canadian Orthopaedic Trauma Society performed the initial randomized clinical trial (RCT).3 However, ORIF with plate fixation is associated with complications including implant irritation, implant failure, persistent loss of sensation around the surgical scar, and wound complications requiring secondary operations for implant removal.1, 2, 3 More than one-third of patients require a secondary operation for implant removal due to complications.1 Of note, 21.7% of implant removals are secondary to implant irritation from traditionally used contoured small-fragment plates.1 Furthermore, patients with lower BMI and females have an increased rate of implant removal due to symptomatic implant irritation.4,5
The above concerns have paved the way for dual plate fixation of displaced midshaft clavicle fractures to become increasingly more common. This technique uses lower profile mini-fragment plates in order to provide orthogonal plane fracture fixation.6 The rationale for dual plate fixation is to provide fixation in orthogonal planes, and to use a lower profile fixation technique in comparison to pre-contoured and surgeon-contoured small-fragment locking plates, which may be more prominent.7 In comparison to superiorly based small-fragment locking plates, mini-fragment fixation is predicted to result in lower rates of symptomatic implant and subsequent requirement for implant removal.9, 10 In biomechanical and finite element analyses, dual mini-fragment plate fixation effectively provides adequate multi-planar bending stiffness, and resistance to torsion and axial loading.7,8
Due to the potential benefits of dual plating for fixation of displaced mid-shaft clavicle fractures, there has been a recent increase in studies evaluating outcomes and complications associated with this technique.6 However, individual study sample sizes were small and there is a paucity of post-operative outcomes reported on dual plating. The purpose of this systematic review was to assess the rate of implant removal following surgical fixation of adult displaced mid-shaft clavicle fractures with dual plate fixation. Secondary outcomes includes an assessment of functional outcomes, non-union rates, implant failure, and wound complications. A meta-analysis was performed on studies comparing implant removal and non-union rates between dual mini-fragment plate fixation and single plate fixation techniques.
2. Methods
This systematic review followed a predetermined study protocol in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Appendix A).
2.1. Search strategy and study selection
Search terms for the study were developed with assistance from a medical librarian, and the databases EMBASE, MEDLINE, and CENTRAL were queried from inception to May 1, 2020 (Appendix B). Additional eligible studies were identified by performing forward and backward reference searching for the studies included in the full text review. Results of the search were compiled using Covidence (Alfred Hospital, Melbourne, Australia) and duplicates were removed. Titles and abstracts were independently screened for eligibility based on inclusion and exclusion criteria by two authors (DY, HK), with accepted studies moving on to full text review. Any discrepancies were resolved by consensus decision between reviewing authors, or by a third reviewer (JK), as needed.
2.2. Inclusion and exclusion criteria
The study included all Level I to Level IV studies (including meeting abstracts) which reported on adult patients 18 years of age or older with acute displaced mid-shaft clavicle fractures who were surgically treated with dual plate fixation. Mid-shaft clavicle fractures were determined to be AO/OTA types 15.2A, 15.2B, and 15.2C. If studies reported on dual plate fixation using small-fragment plates only, they were excluded from the systematic review. Only comparative studies which reported on dual plate fixation with a combination of mini-fragment (2.0 mm, 2.4 mm, 2.7 mm) and small-fragment plates (3.5 mm) or dual plate fixation with mini-fragment plates exclusively were included in the meta-analysis. Dual mini-fragment plate fixation was defined as orthogonal fixation with any combination of two 2.7 mm, 2.4 mm, or 2.0 mm plates. Additionally, studies were required to include a minimum of 10 patients and report on post-operative outcomes including implant removal, fracture union rate, or functional outcomes in order to be included. The most recent or most comprehensive study was included in the review in instances where a study published multiple interim results. Studies were excluded if they reported on the usage of dual plates for surgical fixation of medial or lateral clavicle fractures, clavicle fracture malunions or non-unions, or included surgical fixation with adjuncts such as intramedullary devices, suture wire, Kirschner wire, or external fixation. In addition, case reports, reviews, commentary pieces or rebuttals, and studies or abstracts which were not available in the English language were excluded from the review.
2.3. Data extraction and quality assessment
Data including publication date, study design, patient demographics, and outcomes of interest were independently extracted by two authors (DY and HK) using a standardized data extraction form. The primary outcome of interest was the rate of implant removal following surgical fixation of mid-shaft clavicle fractures using dual plate fixation. Rates of non-union, reduction maintenance, symptomatic implants, wound complications, and functional outcomes were recorded as secondary outcomes. The level of evidence of included studies was determined using the 2011 Oxford Centre for Evidence-Based Medicine Levels of Evidence table.9 Each included study was systematically evaluated using the Risk Of Bias In Non-randomized Studies – of Interventions (ROBINS-I) tool.10
2.4. Data synthesis and analysis
The completed data extraction form was used for qualitative and quantitative analysis of study outcomes. All study outcomes which were reported on by three or more comparative studies were included in a meta-analysis using Review Manager 5.2 (Cochrane Collaboration, Copenhagen, Denmark). Means and standard deviations were used to describe continuous data and dichotomous outcomes were described as number of events or odds ratio (OR). Statistical analysis was performed by comparing the event rates of two or more studies when results were collected using similar measures. Random-effects models for unadjusted/crude study estimates were pooled using Mantel-Haenszel (M − H) weighting for dichotomous variable analysis. Results were summarized using descriptive statistics when meta-analysis was not possible. The I2 statistic was used to assess heterogeneity between studies, with substantial heterogeneity indicated by a value of 75% or greater. Potential sources of between-study heterogeneity were investigated using subgroup analysis comparing dual plate fixation with a combination of mini-fragment and small-fragment plates to dual plate fixation with mini-fragment plates exclusively. Results were considered statistically significant for all analyses if p-values were <0.05.
3. Results
3.1. Study characteristics
Following removal of duplicates, 2226 abstracts were identified. Authors excluded a further 2203 studies following title and abstract screening, leaving 23 studies for the full-text review (Fig. 1). Eight studies7,11, 12, 13, 14, 15, 16, 17 were included in the final systematic review, resulting in the inclusion of 278 patients with mid-shaft clavicle fractures treated with dual plate fixation. Included studies were published between 2011 and 2020, and all studies were retrospective in nature. Five of the studies were retrospective cohort studies,11,13,14,16,17 and three were case series.7,12,15 Of the included studies, five reported on patients surgically treated with only mini-fragment plates,7,12, 13, 14,17 and three included patients treated with dual plate fixation consisting of a combination of mini-fragment and small-fragment plates (Table 1).11,15,16 The mean age of patients was 36.0 years and the majority were male (n = 201; 79.8%). Patients were followed post-operatively for a mean of 8.3–35.0 months. All included studies were Level III or Level IV evidence.
Fig. 1.
PRISMA flow diagram.
Table 1.
Summary of study characteristics and baseline demographics for patients with mid-shaft clavicle fractures treated with dual plate fixation.
| Study | Year | Study Design | Patients, n | Mean Age, years | Female sex, n | Follow-up, mean months (range) | Dual Plate Widths |
|---|---|---|---|---|---|---|---|
| Allis et al. | 2020 | Retrospective cohort | 23 | 36.0 | N/A | 35.0 (26.0–56.0) | Sup: 2.7 mm Ant: 2.4 mm |
| Zhuang et al. | 2020 | Retrospective cohort | 17 | 39.3 | 5 | 11.3 (4.0) | Sup: 3.5 mm Ant: small “aid plate” |
| DeBaun et al. | 2019 | Retrospective cohort | 60 | 44.0 | 17 | 8.3 (2.8–44.2) | Combination of sup/ant 2.7 mm, 2.4 mm, 2.0 mm |
| Lee et al. | 2019 | Retrospective cohort | 33 | 28.9 | 5 | 24a | Sup: 2.7 mm Ant: 2.7 mm |
| Chen et al. | 2017 | Retrospective cohort | 34 | 39.1 | 6 | 9.6 (3.6–31.2) | Combination of 3.5 mm and mini-fragment plates |
| Czajka et al. | 2017 | Case series | 81 | 31.3 | 18 | 15.7 (12.2–64.0) | Sup: 2.7 mm Ant: 2.4 mm |
| Shannon et al. | 2016 | Case series | 13 | 41.0 | 1 | 22.3 (13.0–60.0) | Combination of 3.5 mm and mini-fragment plates |
| Prasarn et al. | 2015 | Case series | 17 | 31.3 | 2 | 16.1 (12.0–38.0) | Sup: 2.7 mm Ant: 2.4 mm |
| Weighted totals (%) | N/A | N/A | 278 | 36.0 | 54 (21.2) | N/A | N/A |
n, number; yrs, years; sup, superior; ant, anterior; N/A, not available.
All patients had minimum 24-month follow-up.
3.2. Study quality
All comparative studies were included in the meta-analysis due to the limited number of studies available. Four of the retrospective cohort studies included in the meta-analysis had a moderate risk of bias,11,13,14,17 and one had a serious risk of bias,16 when assessed using the ROBINS-1 score (Appendix C).
3.3. Dual plate fixation outcomes
In seven studies (n = 197) which evaluated fracture union, the union rate with dual plate fixation for an acute mid-shaft clavicle fracture was 99.5% (n = 196) (Table 2). Eleven out of 261 patients required a secondary operation for implant removal (4.2%). There was a 2.0% (n = 3) rate of symptomatic implant, 0.6% (n = 1) rate of implant failure, and 1.7% (n = 4) rate of post-operative wound complication or infection in studies which reported on implant complications (Table 2).
Table 2.
Summary of outcomes and complications for patients with mid-shaft clavicle fractures treated with dual plate fixation.
| Study | Patients, n | Fracture union, n | Implant removal, n | Symptomatic implant, n | Implant failure, n | Infection/wound complications, n | Functional outcomes |
|---|---|---|---|---|---|---|---|
| Allis et al. (2020) | 23 | 23 | 0 | 0 | 0 | 0 | Mean ASES @ 24 mos: 98 |
| Zhuang et al. (2020) | 17 | 17 | N/A | N/A | 0 | N/A | Mean CMS @6 mos: 91.2 (3.1)a |
| DeBaun et al. (2019) | 60 | 59 | 5 | N/A | N/A | 0 | N/A |
| Lee et al. (2019) | 33 | 33 | 0 | 0 | N/A | 0 | N/A |
| Chen et al. (2017) | 34 | 34 | 0 | N/A | 0 | 2 | N/A |
| Czajka et al. (2017) | 81 | N/A | 6 | 3 | 1 | 2 | Mean QuickDASH: 8.4 (0–77.3)b |
| Shannon et al. (2016) | 13 | 13 | 0 | 0 | 0 | N/A | N/A |
| Prasarn et al. (2015) | 17 | 17 | 0 | N/A | N/A | N/A | Mean DASH @ 12 mos: 4.0 (0–15.8)b |
| Weighted totals (%) | 278 | 196 (99.5) | 11 (4.2) | 3 (2.0) | 1 (0.6) | 4 (1.7) | N/A |
n, number; N/A, not available; mos, months; ASES, American Shoulder and Elbow Surgeons standardized shoulder assessment form; CMS, Constant-Murley Score; DASH. Disabilities of the Arm Shoulder and Hand.
Reported as mean (standard deviation).
Reported as mean (range).
With regards to post-operative functional outcomes, one study reported American Shoulder and Elbow Surgeons standardized shoulder assessment form,17 one study reported Constant-Murley Scores (CMS),16 and two studies reported Disabilities of the Arm, Shoulder, and Hand (DASH) scores.7,12 In the study by Zhuang et al. which compared CMS of patients treated with a single plate or dual plate, the CMS was significantly higher at three months in the dual plate cohort, but not at six months.16
Subgroup analysis was performed comparing patients treated with dual plate fixation using only mini-fragment plates to patients treated with a combination of small-fragment and mini-fragment plates (Table 3). Exclusive use of mini-fragment plates was associated with a 8.3% implant removal rate, compared to 0.0% in the combination plate group. Both groups exhibited high fracture union rates above 99.2%.
Table 3.
Comparison of fracture union and implant removal rates between dual plate fixation consisting of exclusively mini-fragment plates or combination of mini-fragment and small-fragment plates.
| Fracture Union |
Implant removal |
|||
|---|---|---|---|---|
| Total patients, n | Events (%) | Total patients, n | Events (%) | |
| Mini-fragment plates | 133 | 132 (99.2) | 133 | 11 (8.3) |
| Mini-/small-fragment plates | 64 | 64 (100.0) | 47 | 0 (0.0) |
3.4. Single plate versus dual plate outcomes
Five studies (2017–2020) compared outcomes between single plate fixation and dual plate fixation (Fig. 2). All five of the studies compared fracture union rates and four of the studies compared implant removal rates. Single plate fixation was associated with a 3.9-fold increased implant removal rate compared to dual plate fixation with mini-fragment plates or combined fixation with superiorly based mini-fragment plate (odds ratio (OR) = 3.91, 95% CI = 1.58–9.68, p = 0.003; I2 = 0%) (Fig. 3). There was no significant difference in fracture non-union rates between surgical fixation types (OR = 1.66, 95% CI = 0.36–7.67, p = 0.52; I2 = 0%) (Fig. 4).
Fig. 2.
Post-operative radiographs demonstrating: A) superiorly placed 3.5 mm pre-contoured plate fixation for displaced mid-shaft clavicle fractures and; B) dual plate technique with a 2.4-mm LCP superior plate and 2.7-mm reconstruction anterior plate.
Fig. 3.
Comparison of mid-shaft clavicle fracture implant removal rates between single plate fixation and dual mini-fragment plate fixation.
Fig. 4.
Comparison of mid-shaft clavicle fracture non-union rates between single plate fixation and dual plate fixation.
4. Discussion
This systematic review and meta-analysis compares post-operative outcomes following dual plating of mid-shaft clavicle fractures. In active adult patients, primary ORIF with plate fixation is recommended in the management of displaced mid-shaft clavicular fractures.1, 2, 3,18 However, implant complications continue to be a concern and is the most common reason for a secondary surgical procedure, cited as 15.81% in recent literature.18 In this review, we present the analysis of eight systematically identified studies on the outcomes and complications of dual plating displaced mid-shaft clavicle fractures with a cumulative implant removal rate of 4.2%. Furthermore, meta-analyses identified a significantly reduced rate of implant removal with dual plating compared to single plating, with no difference in fracture union rates.
As the clavicle is a subcutaneous bone, ORIF with 3.5 mm plate fixation commonly results in implant irritation. Traditionally, 3.5 mm single plate fixation was used to treat displaced mid-shaft clavicle fractures. However, 3.5 mm plating is associated with a higher reoperation rate for implant removal compared to 2.7 mm plating.19 Pre-contoured 3.5 mm anatomic clavicular plates, which are designed to fit on the superior surface of clavicles, may not be universally conforming in all patients.20 Furthermore, superior plating with 3.5 mm plates is associated with significantly higher rates of symptomatic irritation and secondary operation for implant removal.21 Dual plating with mini-fragment plates offers the advantage of decreased implant irritation in addition to a stiffer construct.6 In a case series of 17 patients, dual mini-fragment plating (superior based 2.7 mm plate, anterior based 2.4 mm plate) was associated with 100% union rate with no requirement for implant removal (average follow-up of 16.1 months).7
In our meta-analysis, only dual plate fixation with a mini-fragment superior plate were used in the comparison of implant removal demonstrating a three-fold decreased risk compared to single plate fixation. Furthermore, the cumulative implant removal rate was much lower than single plate fixation with 3.5 mm small-fragment or pre-contoured plates.
Concern does exist surrounding the additional soft tissue dissection required to apply plate fixation both anteriorly and superiorly; however, it is unclear if this factor has an impact on bony union.15 Moreover, excess construct rigidity with short working lengths can lead to non-union.22 Our review showed that, despite the theoretical risks associated with dual plate fixation, patients demonstrated a fracture union rate of 99.5%. This high union rate may include patients with asymptomatic fibrous or partial unions as radiographic judgement of union with the amount of hardware used in dual plate fixation methods can be difficult.
Increased costs associated with additional implants and operative time are a concern with dual plating of mid-shaft clavicle fractures. In comparison to single, 3.5 mm pre-contoured anatomic plate fixation, dual plate fixation with mini-fragment plates is associated with $258.30 USD in additional implant costs per operation.12 Additionally, Lee et al. found that dual mini-fragment plating was associated with a significantly longer mean operative time of 54.5 min (173.72 min SD = 44.96 min) compared to single plating mean time (118.73 min SD = 40.29 min).14 However, the additional costs associated with dual mini-fragment plate fixation may be mitigated by the cost reduction associated with avoidance of a second surgery for implant removal. In our systematic review, the 4.2% rate of all-cause implant removal using dual plate fixation was much lower than reported secondary procedure rates following conventional single plate fixation of 25.0%–27.4%.2,3 While operative treatment of all adult mid-shaft clavicle fractures may not be cost-effective, careful selection of patients with high-load shoulder professions may be cost-effective.23,24 Compared to single plate fixation, dual plate fixation showed earlier functional recovery at three months in a single study.16 Additional clinical studies comparing patient reported outcomes and return to work between the two fixation techniques are required. Dual plating offers the additional advantage of decreased secondary operation, which may prove to be cost-saving in future analyses.
Strengths of this review include the current relevance of this recently developed surgical technique, as all included studies were published within the last five years. Patients in each of the studies have comparable demographics, including similar mean age and sex distribution, representative of the majority of the mid-shaft clavicle fracture population. By combining patient numbers and outcomes, we were able to demonstrate a significantly decreased implant removal rate with the newer dual plating technique.
This study is not without limitations. The retrospective nature of all included studies has an inherent risk of bias. Although no baseline demographic differences were reported between studies, selection bias was observed in the retrospective cohort study by Chen et al.11 In their study, dual plate fixation was used more commonly in complex, AO/OTA 15.2C type fracture patterns than single plate fixation.11 This may explain why a higher percentage of patients treated with single plate fixation demonstrated radiographic union within three months than patients treated with dual plates.11 In the comparative study by Zhuang et al., AO/OTA 15.2A clavicle fractures were removed, and dual plate fixation was actually associated with a higher rate of union within three months.16 Surgical approach and implants used were not consistently reported between studies. However, as previously described, only dual plate fixation with a mini-fragment plates placed superiorly were used in the meta-analysis on implant removal. Finally, modern aggressive rehabilitation protocols have been suggested to be a cause of lower hardware irritation rates; therefore, only including recent literature introduces the potential that confounding variables like early mobilization may contribute to lower implant irritation rates rather than implant selection alone.
In conclusion, results from this systematic review demonstrate that ORIF of displaced mid-shaft clavicle fractures using a dual plate fixation technique is a viable option to reduce the incidence of implant removal, without negatively impacting rate of fracture union. Potential cost-savings as a result of avoidance of second surgery for implant removal and earlier return to work has not be reported. Future directions include cost-analysis to identify fracture and patient characteristics in which dual plating effectively decreases overall costs associated with secondary operations and return to work. Finally, well-designed prospective trials with appropriate sample sizes are required to further evaluate PROMs, clinical outcomes, and potential cost-savings of dual plating displaced, mid-shaft clavicle fractures.
Funding sources
None.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jcot.2021.03.024.
Appendix A. Supplementary data
The following are the supplementary data to this article:
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