Summary of findings 4. Summary of findings. Surgery (percutaneous wire fixation) versus not surgery (cast only).
Surgery (percutaneous wire fixation) compared with cast alone after closed reduction for displaced distal forearm fractures in children | ||||||
Patient or population: children with displaced distal radius fracture with intact or involved or displaced ulna fracture (both‐bone fracture) Settings: hospital Intervention: surgery (percutaneous wire fixation) and cast (typically above‐elbow) cast after closed reduction Comparison: cast (typically above‐elbow) cast after closed reduction | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Not surgery (cast alone) | Surgery (percutaneous wiring then cast) | |||||
Physical function (short‐term; under 3 months) | See comment | See comment | Not estimable | ‐ | See comment | This outcome was not reported. |
Physical function (medium‐term; 3 to 12 months) measured using the ABILHAND‐Kids score (0 to 42: no problems) (6 months follow‐up; mean 7 months) |
The mean score in the study control group was 41.5 | The mean score in the intervention group was 0.4 higher (0.01 lower to 0.81 higher) | ‐ | 123 children (1 study)a | ⊕⊕⊝⊝ lowb | It is unlikely that this difference is clinically important and there is a strong possibility of a non‐normal distribution or ceiling effect. 3 other trials reported there was no functional deficit at 3 months (56 participants), 4 months (70 participants) and 2.8 years (25 participants) (very low‐quality evidence)c |
'Treatment failure': various secondary procedures such as remanipulation for early loss of position; early or more complex wire removal (Follow‐up 3 to 6 months) |
322 per 1000d | 168 per 1000 (107 to 268) | RR 0.52 (0.33 to 0.83) | 253 participants (4 studies) | ⊕⊝⊝⊝ very lowe | Most secondary procedures took place for early complications (up to 4 weeks). Procedures were mainly wire‐related (e.g. migration, infection) in the surgery group and for loss in position in the cast‐only groupf |
Serious adverse events (typically more serious complications) (Follow‐up 3 to 6 months) | 445 per 1000d | 303 per 1000 (201 to 454) | RR 0.68 (0.45 to 1.02) | 253 participants (4 studies) | ⊕⊝⊝⊝ very lowg | Most complications occurred early and within 4 weeks (i.e. before cast removal). Adverse effects were mainly wire‐related (e.g. migration, infection, scar at K‐wire insertion point) and treatment for loss in position in the cast‐only grouph Where reported, there were no incidences of early physeal closure (2 studies, 57 children) or compartment syndrome (1 study; 34 children) |
Time to return to former activities | See comment | See comment | Not estimable | See comment | This outcome was not reported | |
Wrist pain | See comment | See comment | Not estimable | See comment | This outcome was not reportedi | |
Minor complications (less serious).j Here represented by referral for physical therapy for range of motion limitation (post‐immobilisation after 4 weeks) |
546 per 1000k | 355 per 1000 (241 to 530) | RR 0.65 (0.44 to 0.97) | 128 participants (1 study) | ⊕⊝⊝⊝ very lowl | ‐ |
*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; RR: Risk Ratio | ||||||
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. |
aAll fractures in this trial were displaced both‐bone metaphyseal fractures that appeared stable after reduction. bWe downgraded the evidence by one level for serious risk of bias, reflecting lack of blinding (performance bias), and by one level for indirectness (the scoring system is validated for children with cerebral palsy). We did not downgrade for imprecision, given the results of little between‐group difference, which was unlikely to be clinically important, the small 95% CI and values indicating minimal functional deficit in both groups that were consistent with the findings of three other trials. cThis subsidiary evidence, while reassuring, was downgraded by two levels for very serious risk of bias, refecting various biases including selection bias (allocation concealment unknown or not done) and lack of blinding (performance bias and detection bias), and by one level for serious indirectness, reflecting the vague description of the outcome and results. dThe assumed risk is calculated from the median control group risk across studies. eWe downgradedthe evidence by two levels for very serious risk of bias, primarily reflecting selection bias and lack of blinding (performance and detection biases), and by one level for serious inconsistency reflecting moderate heterogeneity (I2 = 58%). fThe percentage of secondary procedures, usually resulting in re‐reduction but some had wire fixation, for loss of position in the cast‐only group ranged from 21% to 91%. The criteria for this varied among the trials, with current trends towards accepting some displacement. Not included is the routine removal of K‐wires, nowadays typically carried out in the clinic. However, in one trial (conducted in 1997), this routinely involved general anaesthesia in the operating theatre. gWe downgraded the evidence by two levels for very serious risk of bias, primarily reflecting selection bias and lack of blinding (performance and detection biases), and by one level for serious indirectness, reflecting variation or lack of definitions of some complications, including redisplacement. hConsideration of whether redisplacement is a 'complication' will depend on extent to which the decision to act on loss of position may be guided by criteria or personal judgement, or both. The proportion of displacement in the cast‐only group of the four studies ranged from 39% to 91%, but we included only those for which a remedial procedure was undertaken (see footnote 'f'). iOne study reported five children (9% of 56; groups not identified) complained of minor pain upon strenuous activity at three months clinical review. jThese included items such as short‐term wrist or elbow stiffness, skin breakage, and non‐routine treatment adjustments. The only report was of range of motion restrictions that prompted physiotherapy in one trial. kBased on study control group data. lWe downgraded the evidence by two levels for serious risk of bias, reflecting lack of blinding (performance bias and detection bias), and by one level for serious indirectness (the evidence was not available for the other potential complications).