Summary of findings for the main comparison. Summary of findings: figure‐of‐eight bandage versus arm sling.
| Figure‐of‐eight bandage compared with arm sling for treating fractures of the middle third of the clavicle | ||||||
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Patient or population: patients (mainly young male adults) with fractures of the middle third of the clavicle Settings: hospital (initially) Intervention: figure‐of‐eight bandage Comparison: arm sling | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Arm sling | Figure‐of‐eight bandage | |||||
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Shoulder function Constant score (0 to 100 points: higher = better) Follow‐up: 6 to 12 months |
Mean (SD) population Constant score 89 (7)¹ | Mean function in the figure‐of‐eight bandage groups was 0.75 points lower (3.72 lower to 2.39 higher) | MD ‐0.75 points (‐3.72 to 2.39) | 51 (1 study) | ⊕⊝⊝⊝ very low² | The 95% CI does not include a clinically important difference.³ Shoulder function was measured using non‐validated measures in two other trials (61 and 152 participants). Both trials found evidence of similar shoulder function in the two groups |
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Pain (early) Visual Analogue Scale ‐ VAS (0 (no pain) to 10 (worst pain)) Follow‐up: 2 weeks |
Mean pain in the arm sling groups ranged from 0.9 to 1.8 points | Mean pain in the figure‐of‐eight bandage groups was 0.43 points higher (0.35 lower to 1.21 higher) | MD 0.43 points (‐0.35 to 1.21) | 203 (2 studies) | ⊕⊝⊝⊝ very low⁴ | The 95% CI do not include a clinically important difference. A third trial (data for 61 participants) provided very low quality evidence based on a non‐validated scoring system of more pain and discomfort during the course of treatment in the figure‐of‐eight group |
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Treatment failure (Number of participants who have undergone or are being considered for a surgical intervention) |
See comment | See comment | Not estimable | ‐ | See comment | Poorly reported outcome. One trial (152 participants) reported that one participant in the arm sling group had successful surgery for a secondary plexus nerve palsy |
| Clinical healing ‐ time to clinical fracture consolidation (weeks) | Mean clinical healing in the arm sling group was 3.6 weeks | Mean clinical healing in the figure‐of‐eight bandage group was 0.20 weeks longer (0.11 week shorter to 0.51 week longer) | MD 0.20 weeks (‐0.11 to 0.51) | 148 (1 study) | ⊕⊝⊝⊝ very low² | In addition, there were four non‐unions in the figure‐of‐eight group; none were problematic |
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Adverse events ‐ total participants with adverse events |
See comment | See comment | Not estimable | ‐ | See comment | The very low evidence quality data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) did not confirm a difference between the two groups⁵ |
| Quality of life | See comment | See comment | Not estimable | ‐ | See comment | Not measured in any trial |
| Return to previous activities ‐ Resumption of school/work (weeks) | Mean time to return to previous activities ranged across control groups from 3.5 to 4.6 weeks | Mean time to return to previous activities (weeks) ‐ resumption of school/work in the intervention groups was 0.12 weeks lower (0.69 lower to 0.45 higher) | MD ‐0.12 weeks (‐0.69 to 0.45) | 176 (2 studies) | ⊕⊝⊝⊝ very low⁶ | |
| *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 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 These are based on the Constant score in healthy people as reported in Yian 2005.
² We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of blinding. We downgraded the evidence one further level for imprecision given the wide confidence interval and that the available data were from only one trial.
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 two 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 one further level for inconsistency given the considerable heterogeneity between the findings of the two groups (I² = 74%).
⁵ Data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) confirmed a difference between the two groups.
⁶ We downgraded the evidence for this outcome two 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 one further level for imprecision given the low numbers of participants contributing data to this outcome.