Summary of findings for the main comparison. Intramedullary fixation versus open reduction and internal fixation with plate for treating acute middle third clavicle fractures.
| Intramedullary fixation versus open reduction and internal fixation with plate for treating acute middle third clavicle fractures | ||||||
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Patient or population: adults (aged ≥ 16 years) with acute middle third clavicle fractures Settings: hospital Intervention: intramedullary fixation Comparison: plate fixation | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Plate Fixation | Intramedullary fixation | |||||
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Function or disability (overall) Various tools (Constant score and Oxford Shoulder Score) Follow‐up: 6‐12 months |
Mean (SD) population Constant score 89 (7)1 | Mean function or disability (overall) in the intervention groups was 0.45 standard deviations higher (0.08 lower to 0.81 higher) | SMD 0.45 (0.08 to 0.81) | 120 (3 studies) | ⊕⊕⊝⊝ low2 | SMD 0.45 (95% CI 0.08 to 0.81); translates to an absolute improvement of 3.2 points (0.6 to 5.7 points improvement) in the Constant score (0 to 100 points: higher = better) in the intramedullary fixation group This is not a clinically significant difference3 |
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Pain ‐ using the section of Constant score Scale from 0 to 15; with 15 being the best positive score Follow‐up: 12 months |
Mean pain in the control group was 13.1 points | Mean pain ‐ using the section of constant score in the intervention groups was 0.6 higher (0.8 lower to 2 higher) |
MD 0.60 points (‐0.80 to 2.00) |
32 (1 study) | ⊕⊝⊝⊝ very low4 | A second trial (13 participants) reported no difference between the 2 groups in VAS at 4 months |
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Treatment failure (participants who have a non‐routine secondary surgical intervention) ‐ Overall treatment failure Follow‐up: 6‐12 months |
53 per 10005 | 37 per 1000 (9 to 158) | RR 0.69 (0.16 to 2.97) | 133 (4 studies) | ⊕⊝⊝⊝ very low6 | 1 of the 4 trials (50 participants) had no treatment failures in either group |
| Clinical healing ‐ time to clinical/radiographic fracture consolidation (weeks) | Mean clinical healing ranged across control groups from 10.1 to 29.2 weeks | Mean clinical healing: time to clinical/radiographic fracture consolidation (weeks) in the intervention groups was 1.22weeks lower (3.83 lower to 1.39 higher) | MD ‐1.22 weeks (‐3.83 to 1.39) | 98 (3 studies) | ⊕⊝⊝⊝ very low7 | ‐ |
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Adverse events ‐ total of adverse events (various: mainly infection; cosmetic result ‐ e.g. prominent metalwork ‐ and symptomatic hardware) Follow‐up: 6‐12 months |
431 per 10005 |
276 per 1000 (168 to 444) |
RR 0.64 (0.39 to 1.03) | 133 (4 studies) | ⊕⊝⊝⊝ very low8 | Definition, description, and distribution of adverse events and their sequelae varied considerably in the 4 trials. In 1 trial, all 17 pins were removed for undisclosed reasons but probably routinely whereas 8 plates were removed only for complications or by request |
| Quality of life ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | Not measured in any trial |
| Return to previous activities ‐ not measured | See comment | See comment | Not estimable | ‐ | See comment | Not measured in any trial |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RR: risk ratio SD: standard deviation; SMD: standardised mean difference; VAS: visual analogue scale. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1. This is based on the Constant score in healthy people as reported by the SD of the Constant score in healthy people as reported in Yian 2005.
2. We downgraded the evidence for this outcome 2 levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding.
3. For the purposes of this review, the minimally clinical important difference was considered to be 10 points for the Constant score (Kukkonen 2013).
4. We downgraded the evidence for this outcome 2 levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of blinding. We downgraded the evidence 1 further level for imprecision given the wide confidence interval and that the available data were from only 1 trial.
5. Basis for assumed risk was the median baseline risk from the studies in the meta‐analysis.
6. We downgraded the evidence for this outcome 2 levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence 1 further level for imprecision given the total number of events were small and the wide confidence interval includes both no clinical effect and 'appreciable benefit'.
7. We downgraded the evidence for this outcome 2 levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence 1 further level for inconsistency given the significant heterogeneity between the results of the 3 trials.
8. We downgraded the evidence for this outcome 2 levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation, lack of assessor blinding, and the possible unit of analysis issues that could have resulted in double counting for a few participants with ≥ 2 adverse events. We downgraded the evidence 1 further level for imprecision given the total number of events were small and the wide confidence interval includes both no clinical effect and 'appreciable benefit'.