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.