Summary of findings for the main comparison. Summary of findings: Surgical interventions for treating distal tibial metaphyseal fractures in adults.
| Surgical interventions for treating distal tibial metaphyseal fractures in adults | ||||||
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Population: individuals more than 18 years old with distal tibial metaphyseal fractures Settings: hospitals (all linked with a university) Intervention: intramedullary nailing Comparison: plating | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Plating | Intramedullary nailing | |||||
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Patient‐reported functional outcomes (pooled data)1 1. AOFAS score at 1 year 2. OMAS percentage of normal side at 2 years 3. OMAS score at 1 year |
See comment | See comment | SMD 0.28 (‐0.02 to 0.59) |
172 (3 trials) |
⊕⊝⊝⊝ very low2 |
0.2 SD represents a small difference, 0.5 SD a moderate difference and 0.8 SD a large difference. However, this does not mean that the 95% CI includes a clinically important effect. The separate results of two trials (87% of the data) showed no clinically important differences. Only the point estimate and wide CI of the third trial included the possibility of a clinically important effect.3 |
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Need for a secondary/revision operation or substantive physiotherapy for adverse outcomes (e.g. non‐union, malunion or infection) 1 year |
100 per 10004 | 37 per 1000 (12 to 112) |
RR 0.37 (0.12 to 1.12) |
173 (3 trials) | ⊕⊝⊝⊝ very low5 |
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Symptomatic non‐union or malunion, including limping 1 year |
67 per 10004 | 49 per 1000 (12 to 188) | RR 0.72 (0.18 to 2.80) | 173 (3 trials) | ⊕⊝⊝⊝ very low6 |
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Pain
(0 to 40: no pain) 1 year |
The mean pain score in the plating group was 31.5 points | The mean pain score in the nailing group was 1.00 higher (0.63 lower to 0.76 higher) | MD 1.00 (‐0.63 to 2.63) | 85 (1 trial) |
⊕⊝⊝⊝ very low7 |
The CI is unlikely to include a minimal clinically important difference. Higher scores were better |
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Wound complications including superficial/deep wound infection and osteomyelitis 1 year |
147 per 1000 | 70 per 1000 (30 to 162) | RR 0.47 (0.20 to 1.10) | 173 (3 trials) | ⊕⊝⊝⊝ very low8 |
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Fracture union 1 year |
934 per 1000 | 953 per 1000 (888 to 1000) |
RR 1.02 (0.95 to 1.09) |
173 (3 trials) | ⊕⊝⊝⊝ very low9 |
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| *The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AOFAS: American Orthopaedic Foot and Ankle Surgery score; CI: confidence interval; MD: mean difference; OMAS: Olerud and Molander Ankle Functional Score; RR: risk ratio; SMD: standardised mean difference | ||||||
| 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. Functional data were presented as AOFAS data in one trial, and OMAS data in the other two trials but in different ways, as described.
2. The evidence was downgraded two levels for study limitations in design and implementation (all three trials were at high risk of bias, including performance bias) and one level for inconsistency (mainly reflecting pooling of disparate outcome measures and timing of measurement).
3. Individual trial results:
a. AOFAS score (0 (worst) to 100 (best)) at 12 months: MD 2.20 favouring nailing, 95% CI ‐0.97 to 5.37; 85 participants b. OMAS percentage of normal side at 24 months: MD 0.30, 95% CI ‐1.27 to 1.87; 64 participants c. OMAS score (0 (worst) to 100 (best)) at 12 months: MD 15.80, 95% CI 0.80 to 30.80; 23 participants.
4. The basis for the assumed risk was the median plating group risk across studies.
5. The evidence was downgraded one level for study limitations in design and implementation (all three trials were at high risk of bias, in particular performance bias), one level for inconsistency (Chi² = 2.17, df = 1 (P value = 0.14); I² = 54%), and one for imprecision (wide CIs and small numbers).
6. The evidence was downgraded one level for study limitations in design and implementation (all three trials were at high risk of bias, in particular performance bias) and two levels for serious imprecision (wide CIs and small numbers).
7. The evidence was downgraded two levels for study limitations in design and implementation (the trial was at high risk of selection, performance, detection and attrition biases) and one level for imprecision (wide CI and small numbers).
8. The evidence was downgraded two levels for study limitations in design and implementation (all three trials were at high risk of bias, in particular performance bias) and one level for inconsistency (Chi² = 4.55, df = 2 (P value = 0.10); I² = 56%).
7. The evidence was downgraded one level for study limitations in design and implementation (all three trials were at high risk of bias, in particular performance bias) and two levels for serious imprecision (there were few cases of non‐union; if these had been pooled instead the result would have been 3/90 versus 4/83; RR 0.72, 95% CI 0.18 to 2.80).