Functional Outcomes and Complications of Intramedullary Fixation Devices for Midshaft Clavicle Fractures: A Systematic Review and Meta-Analysis.

DOI: https://doi.org/10.21203/rs.2.13080/v2

Abstract

Background: An alternative to the current gold standard in operative treatment of displaced midshaft clavicle fractures using plate osteosynthesis, is internal fixation by means of an intramedullary fixation device. These devices differ considerably in their specifications and characteristics and an adequate evaluation of their clinical results is warranted.

Methods: A systematic review was conducted to identify all papers reporting functional outcomes, union rates and/or complications using an intramedullary fixation device for the management of midshaft clavicle fractures. Multiple databases and trial registries were searched from inception until February 2020. Meta-analysis was conducted based on functional outcomes and type of complication per type of intramedullary fixation device. Pooled estimates of functional outcomes scores and incidence of complications were calculated using a random effects model. Risk of bias and quality was assessed using the Cochrane risk of bias and ROBINS-I tools. The confidence in estimates were rated and described according to the recommendations of the GRADE working group.

Results: Sixty-seven studies were included in this systematic review. The majority of studies report on the use of Titanium Elastic Nails (TEN). At 12 months follow up the Titanium Elastic Nail and Sonoma CRx report an average Constant-Murley score of 94.4 (95%CI 93-95) and 94.0 (95%CI 92-95) respectively. The most common reported complications after intramedullary fixation are implant-related and implant-specific. For the TEN, hardware irritation and protrusion, telescoping or migration, with a reported pooled incidence 20% (95%CI 14-26) and 12% (95%CI 8-18), are major contributors to the total complication rate. For the Rockwood/Hagie Pin, hardware irritation is identified as the most common complication with 22% (95%CI 13-35). The most common complication for the Sonoma CRx was cosmetic dissatisfaction in 6% (95%CI 2-17) of cases.

Conclusion: Although most studies were of low quality, in general, good functional results and union rates irrespective of the type of device are found in the reviewed literature. However, there are clear device-related and device-specific complications for each. The results of this systematic review and meta-analysis can help guide surgeons in choosing the appropriate operative strategy, implant and informing their patient.


Level of Evidence IV


Background

Clavicle fractures are common fractures with an incidence reported of 59.3 per 100,000 person years. [1] Historically, these fractures were predominantly treated non-operatively. However, it has been reported that surgical treatment of displaced mid-shaft clavicle fractures (DMCF) leads to better union rates, improved early functional outcomes, and increased patient satisfaction. [2-4] The current gold standard in operative treatment is Open Reduction Internal Fixation (ORIF) using plates and screws. An alternative to this technique is internal fixation using intramedullary fixation devices. These devices aim to reduce the DMCF in a minimally invasive manner and thereby improving cosmetic satisfaction and union rates while lowering infection rates. [5] There are multiple different intramedullary devices available. Some of these devices are made out of rigid stainless steel while others consist of flexible titanium alloys. Some are not fixated within the bone while others are fixated on either one or both sides of the midshaft clavicle fracture. Since these devices differ considerably in their specifications and characteristics the array and distribution of complications and functional outcomes may vary as well.

The aim of this systematic review is to generate an overview of functional outcomes and complications in the management of DMCF per available intramedullary devices.

Methods

Inclusion Criteria

All titles and abstracts were screened and study inclusion was decided on by two reviewers (PH/TvD). In case of discrepancy in study inclusion, disagreements were discussed until consensus on eligibility was reached. If disagreement persisted after discussion, consensus was met consulting GH. References of retrieved eligible articles were searched for supplementary studies. Studies meeting the following criteria were included:

Abstracts, theses, case reports, biomechanical studies, surgical technique papers, editorials, letters and conference proceedings were not included. Studies using Kirschner wires and screws were excluded. Studies concerning intramedullary fixation for open fractures, pathological fractures, multi-trauma patients, floating shoulders, non-unions or mal-unions were also excluded.

Data Extraction

Studies in the final study selection were divided into subgroups depending on type of implant and ranked according to their study design and level of evidence (Oxford Centre of Evidence Based Medicine) by 2 authors (PH, TvD). The level of evidence (LoE) rating is divided into 5 levels: level I indicates the highest evidence studies, level II high, level III moderate, level IV low and level V very low-evidence studies.[6] Disagreement between the reviewers concerning quality assessment was resolved by discussion.

Data from all included studies were extracted with respect to specific characteristics including title, author, year of publication, number of clavicles reported, type of fracture, intramedullary device used, length of follow-up, functional outcomes, and type and number of complications. Date were extracted and checked for accuracy by PH and TvD. Discrepancies were resolved by discussion. This study was conducted and reported in accordance with the reporting guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. [7] The protocol was prospectively registered in PROSPERO (CRD42018086518).

Risk of bias and quality assessment

The Cochrane risk of bias tool was used for assessing risk of bias in randomized trials.

The risk of bias tool covers six domains of bias: selection bias, performance bias, detection bias, attrition bias, reporting bias, and other bias. Within each domain, assessments are made for one or more items, which may cover different aspects of the domain, or different outcomes.[8]

The ROBINS-I tool was used for assessing risk of bias in non-randomized studies of interventions.[9] This tool assesses seven domains through which bias might be introduced. The first two domains, covering confounding and selection of participants into the study, address issues before the start of the interventions. The third domain addresses classification of the interventions themselves. The other four domains address issues after the start of interventions: biases due to deviations from intended interventions, missing data, measurement of outcomes, and selection of the reported result.

Publication bias was assessed only if 10 or more studies were included in the meta-analysis using funnel plots and Egger's (for continuous outcomes) and Peters' test (for proportions) for funnel plot asymmetry. [10-12] Sensitivity analyses were performed to assess the influence of study quality when there was more than 1 high quality study available according to the ROBINS-I.

The confidence in estimates were rated and described according to the recommendations of the GRADE working group as each outcome was assessed for potential risk of bias, inconsistency, imprecision, indirectness and publication bias.[13]

Data Analysis

A meta-analysis was performed whenever three or more studies per intramedullary device that reported on a functional outcome or type of complication could be included.

Despite anticipated heterogeneity, the individual study proportions were pooled. Pooled estimates with their corresponding 95% confidence intervals were calculated using logit transformation (complications) or using untransformed data (functional outcome scores) within a random effects model framework. A continuity correction of 0.5 was applied if a study had an event probability of either 0 or 1. This continuity correction is used both to calculate individual study results with confidence limits and to conduct the meta-analysis. Heterogeneity of combined study results was assessed by I2, and its connected Chi-square test for heterogeneity, and the corresponding 95% confidence intervals were calculated. Restricted maximum likelihood was used to estimate the heterogeneity variance. 95% Prediction intervals were calculated to present the expected range of true effects in similar studies. [14]

Results

Risk of bias assessment

The results of the Cochrane risk of bias tool are summarized in Table 2 and shows high risk of bias in domains 3 and 4 assessing performing and detection bias. The results of the ROBINS-I risk of bias assessment, summarized in Table 3 shows that the overall ROBINS-I score for most studies were subject to serious or critical risk of bias.

Studies concerning the Rockwood Pin and Hagie Pin

All studies identified concerning these devices described an identical surgical technique. All pins were removed after union between 6-20 weeks through a secondary surgical intervention. Average follow-up of the studies ranged between 6 months and 7 years. The functional outcome scores reported were heterogeneous and therefore not comparable. Only two studies reported a Constant-Murley (92.1±6) [15] or DASH (5.9,) [19]. Other functional outcome scores reported were the Oxford Shoulder Score (45.2±2.3), [15] L’Insalata (95.5 ±7.3), [16] and ASES (88.6 and 89). [20, 24] 

Meta-analysis:

It was not possible to perform a meta-analysis for functional outcomes. A meta-analysis was performed for 6 different complications. Data from 10 studies were used to evaluate nonunion followed by data from 7 studies for infection. Seven studies reported hardware irritation, soft tissue problems [15, 17, 19-21, 23, 24] and hardware failure [15-17, 20, 22-24]. Four studies were included in a meta-analysis for persistent pain. (Figure 2) The highest pooled incidences were found for complications hardware irritation (22%, 95%CI 13-35 in 253 clavicles), soft tissue problems (9%, 95%CI 6-13 in 207 clavicles) and infection (9%, 95%CI 5-16 in 287 clavicles). A pooled incidence of unspecified persistent pain was reported in 6% (95%CI 2-20 in 172 clavicle) of cases. The pooled incidence of hardware failure and nonunion was 6% (95%CI 3-10 in 216 clavicles) and 3% (95%CI 1-8 in 337 clavicles) respectively.

The confidence in the estimates from the meta-analyses according to GRADE ranged between low and very low (Table 4 and Appendix 2).

Studies concerning the Titanium Elastic Nail (TEN)

The first reports on using TEN in the treatment of DMCF dated from 2002. [35] TENs with a diameter varying between 2 and 3.5mm were used. Closed reduction rates were reported in 28 of 35 studies. The rates ranged from 15% [46] to 93% [27]. Most studies report a routine removal of the TEN in all cases mostly through a second surgical intervention but also removal under local anesthesia was described. The earliest routine nail removal was performed at 3 months [56] and the latest on average at 8.8 months. [25]

Meta-analysis:

A meta-analysis was performed for functional outcomes based on 30 studies reporting the Constant-Murley Score and 15 studies reporting a DASH score. (Figure 3) The pooled data for the Constant-Murley score and DASH score at 12 months is 94.4 (95%CI 93.4-95.4 in 1,290 clavicles) and 4.6 (95%CI 2.6-6.7 in 647 clavicles), respectively (figure 3). The confidence in the estimates from the meta-analyses according to GRADE concerning the functional outcomes were considered high due to the consistency and precision of the data in combination with the large number of clavicles involved (Table 4 and Appendix 2). The functional outcomes of two studies were not included in the meta-analysis. [28, 31] Fuglesang et al. [28] report the Constant-Murley and DASH scores of 60 TENs only by means of a line graph and van der Meijden et al. [31] report in-text Constant-Murley scores at 1 year follow up that differ from the line graph displayed. Visual evaluation of the line graphs however seems similar to the pooled incidences from the meta-analysis.

Data from 43 studies were pooled in the meta-analysis for evaluating complications rates using the TEN. Twenty-nine studies reported on infection, 29 studies on hardware irritation, 25 studies on protrusion/telescoping/migration, 19 on hardware failure, 12 on nonunion, 8 on soft tissue problems, 5 on malunion and 3 on pain. (Figure 4) The two most common complications reported, protrusion/telescoping/migration and hardware irritation, are implant-related. The pooled incidence was 12% (95%CI 8-18 in 1,105 clavicles) and 20% (95%CI 14-26 in 1,273 clavicles), respectively.

Malunion after surgical management by means of a TEN was reported in 7% (95%CI 4-11 in 193 clavicles) and hardware failure was 3% (95%CI 2-5 in 800 clavicles). Pooled infection incidence was 2% (95%CI 0-3 in 1,084 clavicles) and the pooled incidence of a nonunion using a TEN was 3% (95%CI 2-4 in 1,436 clavicles). The confidence in the estimates from the meta-analyses according to GRADE concerning the functional outcomes ranged from moderate to very low (Table 4 and Appendix 2)

Studies concerning the Sonoma CRx

Meta-analysis:

Six studies were included in the meta-analysis. Data from 5 studies were pooled for functional outcomes using the Constant-Murley score. The pooled Constant-Murley score at 12 months was 94.0 (95%CI 92-96 in 167 clavicles). Six studies reported on nonunion, infection and hardware failure. Three studies reported cosmetic dissatisfaction. (Figure 5) The pooled incidence for cosmetic dissatisfaction was highest at 6% (95%CI 2-17 in 92 clavicles), followed by of hardware failure (4%; 95%CI 2-8 in 191 clavicles) and infection (3%; 95%CI 1-7 in 191 clavicles). No reports of non-union using the Sonoma CRx were reported, the pooled incidence was 0% (95%CI 0-4 in 191 clavicles).

Two studies reported on persistent pain as a complication [68, 71] and 1 study mentions the occurrence of a delayed union. [67]

The confidence in the estimates from the meta-analyses according to GRADE concerning the functional outcomes were considered moderate. Although the results were consistent, the data originate from very limited group of authors. The confidence in the other meta-analyses according to GRADE were low to very low (Table 4 and Appendix 2).

Studies concerning a threaded elastic nail

Meta-analysis was only possible for infection [73-75] and the pooled incidence was 5% (95%CI 1-34 in 106 clavicles).

The confidence in the estimates from this meta-analysis according to GRADE was very low (Table 4 and Appendix 2). Other complications described for this type of fixation were soft tissue problems, delayed union and malunion. (Table 2)

Studies concerning the Knowles Pin

One study reported 4 hardware irritations in 56 patients [77] and another study reported a nonunion rate of 5.6%. [79] No meta-analysis was possible for this device type.

Study concerning a second generation TEN

One level IV study described the results of a second generation TEN in 36 patients. [80] It reported a Constant-Murley score of 93.4 (SD2.7) and 3 complications; 2 protrusions and 1 hardware irritation.

Sensitivity analysis

The sensitivity analysis including only studies with a low risk of bias showed our results to be robust. The complete results of the sensitivity analysis can be found in Appendix 3.

Publication bias

In those cases that publication bias could be assessed, its presence was unlikely based on the inspection of the funnel plots and evaluation of Egger’s or Peters’ tests. Only for the Constant Murley and DASH scores the tests for funnel plot asymmetry were significant, but publication bias seems unlikely here due to ceiling effects in both scores.

Discussion

In this study the functional outcomes and complications after surgical treatment of DMCF with an intramedullary device were systematically reviewed. Good functional results and union rates irrespective of the type of device are found in the reviewed literature. However, there are clear device-related and device-specific complications for each. The pooled Constant-Murley scores of the TEN and Sonoma CRx were 94.4 (95%CI 93-95) and 94.0 (95%CI 92-96), respectively. Since the Constant-Murley score ranges from 0-100 points and higher scores are better, the pooled scores can be considered good. Though the minimally clinical important difference (MCID) for both the Constant-Murley score is unknown for midshaft clavicular fractures in particular it is described that the MCID in Constant Murley scores for shoulder pathology is 10.4 points. [81] Therefore, with an SD reported well within that range our conclusion seems valid as is the confidence in the estimate according to GRADE. The pooled DASH score for the TEN was 4.6 (95%CI 2.6-6.7). The functional outcomes for the Rockwood/Hagie pin could not be analyzed because all identified papers reported different functional outcome measures. This study supports the need for uniform reporting of functional outcomes and in the case of clavicle fracture treatment the Constant-Murley and the DASH are the ones most commonly used.

The most commonly reported complications after intramedullary fixation of DMCFs are implant-related and implant-specific complications. For the TEN, hardware irritation, protrusion, telescoping and migration, are major contributors to the total complication rate. The explanation for this finding may be that the TEN re-aligns but does not fixate in both fracture elements of the DMCF. These TEN-specific complications lead to infection, soft-tissue problems, pain, early re-interventions (removal or additional cutting of the nail) and loss of reduction with subsequent secondary shortening. When using the Rockwood/Hagie Pin, pooled incidence of hardware irritation was 22% (95%CI 13-35). This may be explained by the two bulky nuts at the posterolateral aspect of the clavicle where the pin is inserted and is has been reported to be an important disadvantage of the implant. [15, 19, 22] For the Sonoma CRx no reports on hardware irritation were found since this device has no extra-cortical prominences and is fully embedded in the clavicular cortex.

With regards to the TEN, there is a pooled malunion incidence of 7% (95%CI 4-11). Reports on persistent average shortening after union range between 3.5 and 6.3mm. [27, 37, 54] Others report on shortening after union of more > 1cm in 2.3%-50% of cases. [41, 57, 60] Since shortening of the DMCF can lead to post-traumatic symptoms, altered scapular kinematics and the occurrence of gleno-humeral joint arthritis, shortening is an important issue to prevent and could be interpreted as a disadvantage of this intramedullary fixation device.

There are no studies specifically reporting on the presence or absence of post-operative shortening after fracture fixation with the Sonoma CRx. Concerning the Rockwood pin only Mudd et al. [21] reports a secondary shortening of 4-7mm in 22% of patients which all occurred after early pin removal due to complications.

The pooled incidence for infection was 9% (95%CI 5-16) when using the Rockwood/Hagie pin, 3% (95%CI 1-7) when using the Sonoma CRx and 2% (95%CI 0-3) with use of the TEN. The two postero-lateral nuts that can cause wound-breakdown and subsequent infection may explain the high infection rate of the Rockwood/Hagie pin.

Hardware failure was 6% (95%CI 3-10) for the Rockwood/Hagie Pin compared to 3% (95%CI 2-5) for TEN and 4% (95%CI 2-8).

Meta-analysis shows nonunion incidences to be similar between the Rockwood/Hagie pin (3% ;95%CI 1-8) and to 3% (95%CI 2-4) with the use of the TEN. The pooled incidence of nonunion for the Sonoma CRx was 0% (95%CI 0-4). Although no non-unions were reported in the Sonoma CRx group the confidence this outcome according to GRADE was low due to the limited number of clavicles included and the select group of authors introducing the risk of bias.

This systematic review furthermore identified the common denominator amongst many authors that routine removal of hardware is not considered a complication. However, a case could be made that every secondary intervention including hardware removal is an additional procedure which subjects the patient to associated morbidity and costs and therefore is not desirable.

As for all systematic reviews this study is limited by the quality of evidence available. In most meta-analyses of reported complications the evidence was graded as low to very low. Furthermore, only studies written in English, German or Dutch were included in this systematic review which could be a potential limitation of this study. Complications and early re-interventions are reported in some studies, [21, 33-35, 51, 54, 57] but underreporting is very likely to occur. Most studies do not clearly report causes for implant failure, measures taken with occurrence of infection or information concerning implant migration or secondary shortening. Only few specifically report on the presence or absence of certain relevant complications such as secondary shortening, neuropathy of the supraclavicular nerve, delayed union and persistent pain. This information could be interesting to fully report in future studies and is a limitation of this review. Another limitation is that not all functional outcomes and complications were reported in a similar manner leading to heterogeneity of the various studies. To account for the expected heterogeneity, a random effects model was used. In the case of functional outcome scores for TEN and Sonoma the confidence in the estimates was high and moderate, respectively. Lastly, the follow up differed between studies ranging from 3 months to 7 years. This may have resulted in differences in reporting of complications and functional outcomes. Although most complications would likely occur within the first 3 months this could lead to underreporting this could further negatively influence the confidence in the estimates reported.

In the last years multiple meta-analysis comparing the gold standard of plate fixation and intramedullary devices (irrespective of device or plate type) for the management of midshaft clavicle fractures have been published.[82-89] These studies report similar [82-84, 86-88] or superior [85, 89] functional outcomes and union rates in the intramedullary fixation group. Furthermore, most report a higher rate of complications (such as infection, refracture rate) and increased surgical time when using plate fixation, making an evaluation of the devices described in the present study even more relevant.[82, 83, 86-89]

The results of this systematic review show there is still room for improvement in treating DMCF in an intramedullary fashion. For newer designs it may be interesting to take the implant-related and implant-specific complications described in this systematic review into account in order to optimize future treatment strategies.

Conclusion

Although most studies were of low quality, in general, good functional results and union rates irrespective of the type of device are found in the reviewed literature. However, there are clear device-related and device-specific complications for each. The results of this systematic review and meta-analysis can help guide surgeons in choosing the appropriate operative strategy, implant and informing their patients.

Declarations

Ethics Approval and Consent to participate

The need for approval by the ethics committee and Consent to participate was waived by our institutional review board (CMO Arnhem-Nijmegen).

Consent for publication

Not applicable.

Availability of Supporting Data

The detailed search strategy for this systematic review is available in Appendix 1. The review protocol adhered to by the authors is available via PROSPERO (CRD42018086518). The PRISMA flowchart is available in Figure 1. Appendix 2 and 3 contain the GRADE assessment by domain and the sensitivity analysis.

Competing Interests

All authors declare that they have no competing interests.

Funding

Not applicable.

Authors’ contributions

PH contributed in the conception and design of the study, acquisition and analysis of the data, drafting and critical revision of the manuscript. TD contributed in the conception and design of the study, acquisition and analysis of the data, drafting and critical revision of the manuscript. NV contributed in the conception and design of the study and critical revision of the manuscript.

GH contributed in the conception and design of the study, analysis of the data and critical revision of the manuscript.

All authors read and approved the final version of the manuscript.

Acknowledgements

None

Authors’ information

Paul Hoogervorst. Radboud University Medical Center, Nijmegen, The Netherlands. [email protected]

Tess van Dam. BAAT Medical BV, Hengelo, the Netherlands. [email protected]

Nico Verdonschot, Radboud University Medical Center, Nijmegen, The Netherlands. [email protected]

Gerjon Hannink. Radboud University Medical Center, Nijmegen, The Netherlands. [email protected]

Abbreviations

ASES = American Shoulder Elbow Surgeons

CI = Confidence Interval

DASH = Disabilities of Arm Shoulder Hand

DMCF = Displaced Mid-shaft Clavicle Fractures

FL = Florida

IN = Indiana

LoE = Level of Evidence

MCID = Minimally Clinical Important Difference

MI = Michigan

ORIF = Open Reduction Internal Fixation

PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analyses

TEN = Titanium Elastic Nail

USA = United States of America

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  60. Lu CC, Liu PC, Huang SH, Hsieh CH, Tien YC, Chien SH: Complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 2014, 37:e377-e383.
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  64. Frima H, Hulsmans MHJ, Houwert RM, Ahmed Ali U, Verleisdonk E, Sommer C, van Heijl M: End cap versus no end cap in intramedullary nailing for displaced midshaft clavicle fractures: influence on implant-related irritation.Eur J Trauma Emerg Surg 2018, 44:119-124.
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Tables

Table 1








Functional Outcomes

 

Complications

 

Author

Year

Level of Evidence

Study Design

Number of Patients

Clavicles

CMS (SD) at 12 months

DASH (SD) at 12 months

Quick DASH (SD) at 12 months

 

Number of complications

Hardware irritation

Soft tissue problems

Hardware failure

Infection

Non-union

Protrusion/Telescoping/Migration

Delayed union 

Malunion

Pain

Cosmetic dissatisfaction

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rockwood Pin & Hagie Pin

 

 

 

 

 

 

 

 

 












 

Strauss et al.

2007

4

RCS

16

16

 

 

 

 

8


3

2


0




1


 

Judd et al.

2009

1

RCT

29

29

 

 

 

 

21

9


1

8

1


1




 

Ferran et al.

2010

1

RCT

17

17

92.1 (6)

 

 

 

4


1

1


0






 

Mudd et al.

2011

4

RCS

18

18

 

 

 

 

16

3

3


2

3

2

1


1


 

Kleweno et al.

2011

3

RCS

18

18

 

 

 

 

5

2

1

1

1

0






 

Millett et al.

2011

4

RCS

51

51




 

15


5

2

2

5


1




 

Payne et al.

2011

4

RCS

68

68

 

 

 

 

62

30


3

7

2


1


15


 

Frye et al.

2012

4

RCS

17

17

 

 

 

 

11

7

1

2

 

0

 

 

 

 

 

 

Marlow et al.

2012

4

RCS

70

70

 

5.9*

 

 

31

12

4


8

2




1


 

Wenninger et al.

2013

3

RCS

33

33

 

 

 

 

3

2



1

0






 

 

 

 

 

 

 

 

 

 

 












TEN

 

 

 

 

 

 

 

 

 

 












 

Jubel et al.

2002

2

PCS

65

65

96.9 (3.3)

 

 

 

8


2



1

5





 

Jubel et al.

2002

3

RCC

20

20

97 (4)

 

 

 

0





0






 

Jubel et al.

2003

3

RCS

55

58

97.9 (3.3)

 

 

 

9

3

2


0

1

2





 

Jubel et al.

2003

2

PCS

12

12

98.3 (1.5)

 

 

 

0




0

0






 

Jubel et al.

2005

2

PCC

26

26

 

 

 

 

20

8



0

0

2





 

Kettler et al.

2005

4

RCS

55

55

81 (7.1)

 

 

 

31

14

2


0

1

6


2

2


 

Walz et al.

2006

2

PCS

35

35

98.1 (1.3)

 

 

 

6

5



0

0

1





 

Keener et al.

2006

4

RCS

24

24

 

 

 

 

13

6

 

2

 

 

1

1

3

 

 

 

Kettler et al.

2007

4

RCS

87

87

84 (9)

6.9 (7.2)

 

 

23

4



0

2

4


7


4

 

Mueller et al.

2007

4

RCS

32

32

95 (1.9)

5 (2.3)

 

 

16

5


2

1

0

8





 

Witzel 

2007

2

RCT

35

35

 

 

 

 

0











 

Hartmann et al.

2008

4

RCS

15

15

95.3 (3.9)

 

 

 

4

4



0

0






 

Frigg et al.

2009

4

RCS

34

34

 

1.5 (3.2)

 

 

24

7


1


0

15



1


 

Smekal et al.

2009

1

RCT

30

30

97.9 (1.7)

 

 

 

10



2

0

0

7

1




 

Liu et al.

2010

3

RCC

51

51

86.7 (5.3)

13.5 (3.9)

 

 

20

4


4

3

5



4



 

Frigg et al.

2011

3

RCC

44

44

 

1.4 (3.1)

 

 

14

5

 

1

 

1

6

 

 

 

 

 

Chen et al.

2011

1

RCT

30

30

97 (4.3)

2.74 (3.6)

 

 

10

3


1

1

0

3





 

Assobhi 

2011

1

RCT

19

19

95.5 (5.3)

 

 

 

4

3


0

0

0





1

 

Smekal et al.

2011

1

RCT

60

60

98 (3.6)

0.5 (1.8)

 

 

19

5


2

1

0

7

2




 

Kadakia et al.

2012

4

RCS

38

38

 

 

6.7 (3.4)

 

11

18



0

0

1





 

Wijdicks et al.

2012

4

RCS

47

47

 

 

 

 

60

29


1

4

0

26



2


 

Tarng et al.

2012

3

RCC

25

25

96 (2)

 

 

 

4


4


0

0






 

Chen et al.

2012

3

RCC

57

57

95 (3.2)

4 (4.4)

 

 

32

4


3

1

1

17





 

Prokop et al.

2013

4

RCS

136

136

97(3)

 

 

 

1

 

 

1

 

 

 

 

 

 

 

 

Langenhan et al.

2014

4

RCS

37

37

96.0 (5.3)

3 (5)

 

 

4




1

0

3





 

Saha et al.

2014

2

PCC

34

34

 93.5 (4.4)

 

 

 

13

12



0

0






 

 Shokouh et al.

2014

4

RCS

12

13

 

 

 

 

0




0

0






 

Braun et al.

2014

4

RCS

40

40

86.3 (8.1)

5.5 (6.9)

 

 

19

1

2



0

12





 

Narsaria et al.

2014

2

PCC

33

33

94.6 (3.2)

 

 

 

4



1

1

1






 

Suresha et al.

2014

4

RCS

20

20

94.6*

 

 

 

0



0

0

0






 

Lu et al.

2014

4

RCS

27

27

93,6 (9)

6.2 (11.1)

 

 

17

8


0

0

0

9





 

Wang et al.

2015

3

RCC

25

25

93.8 (8.9)

5.5 (10.5)

 

 

12

5


0

0

0

5





 

Andrade-Silva et al.

2015

1

RCT

25

25

91.8 (8.8)

7.5 (12.5)

 

 

10

10




1






 

van der Meijden et al.

2015

1

RCT

62

62

96.3 (11.8)

3.9 (10.2)

 

 

43

33










 

Eden et al.

2015

2

PCC

24

24

 

 

 

 

5

1



1

1

2

1




 

Mishra et al.

2016

3

PCC

73

73

96.8 (2.3)

 

 

 

15

7



3

0

2

3




 

Lechler et al

2016

3

RCC

36

36

87.7 (10.7)

3.9 (6.6)

 

 

12





3






 

Fuglesang et al.

2017

1

RCT

60

60

 

 

 

 

36

19

4

2


1






 

Govindasamy et al.

2017

4

RCS

54

54

97.8 (1)

 

 

 

19

15



3

0

1

1




 

Eickhoff et al.

2018

3

RCC

99

99

 

 

 

 

39

29

1

 

 

2

26

 

 

 

 

 

Eisenstein et al.

2018

4

RCS

7

7

 

 

 

 

4

2

1

 

 

 

1

 

 

 

 

 

Frima et al.

2018

4

RCC

34

34

 

 

 

 

20

 

 

4

0

 

 

 

 

 

 

 

Zhang et al.

2019

3

RCC

37

37

97.3 (13.7)

 

 

 

2

 

 

0

1

 

 

 

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 











Sonoma CRx 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zehir et al.

2015

1

RCT

24

24

 

 

7.7 (2.2)

 

8

 

 

1

0

0

 

 

 

3

4

 

King et al.

2015

2

PCS

47

47

90 (13)

11 (18)

 

 

3

 

 

2

1

0

 

 

 

 

 

 

Zehir et al.

2015

4

RCS

17

17

94.3 (2.8)

11.8 (2.5)

 

 

2

 

 

1

1

0

 

 

 

 

 

 

Calbiyik et al.

2016

1

RCT

35

35

92.9 (4)

 

3.8 (1.6)

 

5

 

 

2

1

0

 

1

 

 

1

 

Zehir S et al.

2016

3

RCC

33

33

94.3 (5.3)

 

 

 

4

 

 

1

2

0

 

 

 

2

1

 

King et al.

2019

1

RCT

35

35

97 (5)

5 (6)

 

 

3

 

1

1

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Threaded Pin

 

 

 

 

 

 

 

 

 

 












 

Zenni et al.

1981

4

RCS

21

21

 

 

 

 

7

 

 

1

0

 

0

 

 

 

 

 

Grassi et al

2001

3

RCC

40

40

82.9 (8)

 

 

 

15

 

 

 

8

2

 

2

 

 

 

 

Bi et al.

2015

2

PCS

45

45

96.5 (9)

1.4 (12.5)

 

 

20

 

19

1

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Knowles Pin

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chu et al

2002

4

RCS

78

78

92 (13.8)

 

 

 

4

 

 

1

 

 

 

3

 

 

 

 

Lee et al

2007

2

RCT

32

32

85 (8.8)

 

 

 

0

 

 

 

 

 

 

 

 

 

 

 

Lee et al.

2008

3

RCC

56

56

 

 

 

 

4

4

 

 

 

 

 

 

 

 

 

 

Wu et al.

2013

4

RCC

337

337

 

 

 

 

19

 

 

 

 

19

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2nd Generation TEN

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fu

2016

4

RCC

36

36

93.4 (2.7)

2.5 (1.6)

 

 

3

1

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Table 2










 

Domain 1: Selection bias (Random sequence generation)

Domain 2: (Selection bias) Allocation concealment

Domain 3: Performance bias
 Blinding (participants and personnel) 

Domain 4: Detection bias
 Blinding (outcome assessment) 

Domain 5: Attrition bias
 Incomplete outcome data 

Domain 6: Reporting bias

 

  Domain 7: Other bias

 

Sonoma CRx

Zehir et al. 

2015

Calbiyik et al.

2016

King et al.

2019

Rockwood & Hagie Pin

Judd et al. 

2009

Ferran et al.

2010

TEN

Witzel 

2007

Smekal et al.

2009

Chen et al.

2011

Asshobi

2011

Smekal et al

2011

Andrade-Silva

2015

Van der Meijden et al.

2015

Fuglesang et al.

2017

Knowles Pin

Lee et al.

2007

Table 2. Cochrane risk of bias assessment of randomized trials. Green = Low Risk, Red = High Risk, Yellow = Unknown Risk.


Table 3

 

 Author

Year

Domain 1: Confounding

Domain 2: 

Selection of participants

Domain 3: 

Classification of intervention

Domain 4: 

Deviation from interventions

Domain 5: 

Missing data Domain

Domain 6: 

Measurement of outcomes

Domain 7: 

Selection of reported results

ROBINS-I overall

Sonoma CRx












Zehir et al.

2015

2

2

2

1

2

2

2

2


King et al.

2015

3

3

2

1

2

2

2

3


Zehir et al.

2015

3

3

2

1

3

2

2

3


Calbiyik et al.

2016

2

1

1

1

1

2

2

2


Zehir S et al.

2016

3

2

2

1

2

2

3

3

Rockwood Pin & Hagie Pin











Strauss et al.

2007

4

3

3

1

2

3

3

4


Judd et al.

2009

2

2

1

1

1

2

2

2


Ferran et al.

2010

2

2

2

1

1

2

2

2


Mudd et al.

2011

3

3

2

1

1

3

2

3


Kleweno et al.

2011

3

2

2

1

1

3

3

3


Millett et al.

2011

3

3

3

1

2

2

2

3


Payne et al.

2011

3

2

2

1

2

2

2

3

 

Frye et al.

2012

3

3

3

1

2

3

3

3


Marlow et al.

2012

3

3

2

1

2

2

2

3


Wenninger et al.

2013

3

2

2

1

2

3

2

3

TEN












Jubel et al.

2002

2

2

1

1

2

2

2

2


Jubel et al.

2002

2

3

2

1

1

2

2

3


Jubel et al.

2003

3

3

2

1

2

2

3

3


Jubel et al.

2003

3

3

1

1

2

2

2

3


Jubel et al.

2005

2

3

1

1

1

2

2

3


Kettler et al.

2005

4

3

1

1

2

2

2

4


Walz et al.

2006

2

2

1

1

1

2

2

2

 

Keener et al.

2006

4

3

2

1

3

2

3

3


Kettler et al.

2007

3

3

2

1

2

2

2

3


Mueller et al.

2007

2

2

1

1

1

2

1

2


Witzel 

2007

3

2

2

1

2

2

2

3


Hartmann et al.

2008

3

3

2

1

2

2

3

3


Frigg et al.

2009

3

2

1

2

2

2

3

3


Smekal et al.

2009

2

2

1

1

1

2

2

2


Liu et al.

2010

3

3

2

1

2

2

3

3

 

Frigg et al.

2011

2

2

1

1

3

2

2

3


Chen et al.

2011

2

2

1

1

1

2

2

2


Assobhi 

2011

2

2

2

1

1

2

2

2


Smekal et al.

2011

2

2

1

1

1

2

2

2


Kadakia et al.

2012

4

3

2

1

2

3

2

4


Wijdicks et al.

2012

3

2

3

1

2

3

2

3


Tarng et al.

2012

3

3

3

1

2

2

2

3


Chen et al.

2012

3

3

2

1

2

2

2

3

 

Prokop et al. 

2013

3

3

2

1

3

2

3

3


Langenhan et al.

2014

2

3

2

1

2

2

3

3


Saha et al.

2014

3

2

2

1

2

2

2

3


Keihan Shokouh et al.

2014

2

3

2

1

2

3

2

3


Braun et al.

2014

2

3

2

1

2

2

2

3


Narsaria et al.

2014

2

2

1

1

2

2

2

2


Suresha et al.

2014

3

3

2

1

2

2

2

3


Lu et al.

2014

2

3

1

1

2

2

2

3


Wang et al.

2015

2

3

1

1

2

2

2

3


Andrade-Silva et al.

2015

2

1

1

1

1

2

1

2


van der Meijden et al.

2015

2

1

1

1

1

2

1

2


Eden et al.

2015

3

2

2

1

2

2

2

3


Mishra et al.

2016

2

2

2

1

2

2

2

2


Lechler et al

2016

3

3

2

1

2

2

2

3


Fuglesang  et al.

2017

2

2

1

1

2

2

2

2


Govindasamy et al.

2017

3

3

2

1

3

2

2

2

 

Eickhoff et al.

2018

2

2

1

1

2

2

2

2

 

Eisenstein et al.

2018

3

2

2

1

2

2

2

3

 

Frima et al.

2018

2

2

2

1

2

2

2

2

 

Zhang et al. 

2019

2

3

2

1

3

3

3

3

Threaded Pin












Zenni et al.

1981

4

4

2

1

2

3

2

4


Grassi et al

2001

3

3

2

1

2

2

2

3


Bi et al.

2015

2

2

2

1

2

2

2

2

Knowles Pin












Chu et al

2002

3

3

2

3

3

2

3

3


Lee et al

2007

3

2

2

1

2

2

2

3


Lee et al.

2008

3

3

2

1

2

2

2

3


Wu et al.

2013

3

2

2

1

2

3

2

3

Table 3  . ROBINS-I assessing risk of bias in non-randomized studies of interventions. 1= Low risk of bias, 2= Moderate risk of bias, 3= Serious risk of bias, 4= Critical risk of bias. 


Table 4

Device

Outcome

No. of Studies

No. of Clavicles

Effect estimate (95%CI))

Quality of evidence (GRADE) 

 

 

 

 

 

 

Rockwood Pin & Hagie Pin

 

 

 

 

 

 

Hardware Irritation

7

253

0.22 (0.13 – 0.35)

⨁⨁⨀⨀ LOW

 

Infection

7

287

0.09 (0.05 – 0.16)

⨁⨁⨀⨀ LOW

 

Soft Tissue Problems

7

207

0.09 (0.06 – 0.13)

⨁⨁⨀⨀ LOW

 

Pain

4

172

0.06 (0.02 – 0.20)

⨁⨀⨀⨀ VERY LOW

 

Hardware Failure

7

216

0.06 (0.03 – 0.10)

⨁⨁⨀⨀ LOW

 

Nonunion

6

191

0.00 (0.00 – 0.04)

⨁⨁⨀⨀ LOW

 

Scar Numbness

4

173

0.05 (0.02 – 0.09)

⨁⨀⨀⨀ VERY LOW

 

Delayed Union

4

166

0.02 (0.01 – 0.06)

⨁⨀⨀⨀ VERY LOW

 

 

 

 

 

 

TEN

 

 

 

 

 

 

CMS

29

1270

94.40 (93.43 – 95.37)

⨁⨁⨁⨁ HIGH

 

DASH

15

647

4.65 (2.61 – 6.68)

⨁⨁⨁⨁ HIGH

 

Hardware Irritation

30

1273

0.20 (0.14 – 0.26)

⨁⨁⨁⨀ MODERATE

 

Protrusion

25

1105

0.12 (0.08 – 0.18)

⨁⨁⨁⨀ MODERATE

 

Malunion

3

193

0.07 (0.04 – 0.11)

⨁⨁⨀⨀ LOW

 

Soft Tissue Problems

8

406

0.04 (0.03 – 0.08)

⨁⨀⨀⨀ VERY LOW

 

Pain

3

136

0.04 (0.02 – 0.09)

⨁⨀⨀⨀ VERY LOW

 

Nonunion

36

1436

0.03 (0.02 – 0.04)

⨁⨁⨁⨀ MODERATE

 

Hardware Failure

19

800

0.03 (0.02 – 0.05)

⨁⨁⨀⨀ LOW

 

Delayed Union

6

265

0.03 (0.02 – 0.06)

⨁⨀⨀⨀ VERY LOW

 

Infection

29

1084

0.02 (0.01 – 0.03)

⨁⨁⨁⨀ MODERATE

 

 

 

 

 

 

Sonoma CRx

 

 

 

 

 

 

CMS

5

167

94.03 (92.31 – 95.76)

⨁⨁⨁⨀ MODERATE

 

DASH

3

99

9.16 (3.94 – 14.37)

⨁⨁⨁⨀ MODERATE

 

Cosmetic Dissatisfaction

3

92

0.06 (0.02 – 0.17)

⨁⨀⨀⨀ VERY LOW

 

Hardware Failure

6

191

0.04 (0.02 – 0.08)

⨁⨁⨀⨀ LOW

 

Infection

6

191

0.03 (0.01 – 0.07)

⨁⨁⨀⨀ LOW

 

Nonunion

6

191

0.00 (0.00 – 0.04)

⨁⨁⨀⨀ LOW

 

 

 

 

 

 

Threaded Pin

 

 

 

 

 

 

Infection

3

106

0.01 (0.00 – 0.64)

⨁⨀⨀⨀ Very Low

 

 

 

 

 

 

 

GRADE Working Group grades of evidence

High certainty: We are very confident that the true effect lies close to that of the estimate of the effect

Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different

Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect

Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect