Kropman 2010.
Methods | Randomised trial Study period: September 2005 to October 2006 | |
Participants | St Antonius Hospital, Nieuwegein, The Netherlands 92 children with impacted greenstick fracture of the distal radius or ulna Inclusion: impacted greenstick fracture, which comprised ⅓ of the distal radius or ulna, age between 4 and 13 years; signed informed consent Exclusion: complicated fractures or the necessity to reposition the fracture. Patients with a typical greenstick fracture Sex: 53 male (59% of 90) Age: mean 10 (range 4 to 12) years Fracture type (of 90): radius only (81: 90%), ulna only (1: 1%, by deduction); both radius and ulna 8 (9%) Assigned: 46 (bandage) / 46 (cast) Analysed: 44 (bandage) / 44 (cast) (at 6 weeks) |
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Interventions | 1. Soft bandage (layer of wool, which was covered with a layer of commercial cotton crepe bandage) supported by a sling. After 1 week, a tubigrip was placed for 3 weeks. The group participants were given verbal and written instructions on handling the bandage and removing the bandage for comfort only, or removing for desired activities, and discontinue completely when desired 2. Below‐elbow back‐slab cast. After 1 week, the cast was made circular and continued for another 3 weeks. The group participants were given the usual verbal and written cast‐care instructions (e.g. avoid getting the cast wet) All participants were instructed to avoid contact sports until 4 weeks after treatment. Participants were seen after 1, 4, and 6 weeks |
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Outcomes | Length of follow‐up: 6 weeks, also at 1 and 4 weeks Wrist function: not reported Complications: secondary angulation (none), refractures (none), change in treatment (conversion from bandage to cast at request of parents (within 1 week)), problems removing bandage Fracture displacement Pain Range of motion Discomfort (itching, neck pain, too heavy, too loose, too tight) |
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Funding and declarations of interest | Funding source: not stated Declarations of interest: not stated |
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Notes | Clarification provided in the text of the fracture population: "An impacted greenstick fracture, torus fracture, or buckle fracture is defined as a specific type of greenstick fractures in which the cortex has become impacted." Although 92 children were recruited, one child in each group was excluded early on because incorrect diagnosis: one had a contusion of the distal forearm and the other had a Salter Harris II fracture. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The enrolled patients were thereafter prospectively randomised between soft bandage and CT using a randomisation plan from www.randomization.com". |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomisation scheme was obtained by using sealed envelopes containing the indication to BT or CT that were put into a container in 15 blocks (3 BT, 3 CT)." The envelopes were extracted by the physician in the emergency department. However, safeguards (the envelopes were not described as opaque) are not mentioned and it is possible that the sequence may have been partly predictable |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Blinding not feasible |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Blinding not feasible |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No blinding reported |
Blinding of outcome assessment (detection bias) Objective outcomes | High risk | No blinding reported |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Participant flow diagram provided but incomplete account of losses to follow‐up. The denominators of group participants for participant‐/parent‐recorded pain and discomfort were not provided. In particular the allocation of 5 participants whose VAS and discomfort form data were lost at 2 and 3 weeks was not provided. Intention‐to‐treat analysis was conducted including in the retention in the bandage group of 3 participants who switched from bandage to cast therapy |
Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Participant flow diagram provided and loss to follow‐up (1 excluded and 1 loss to follow‐up in each group) provided for these outcomes. (The 3 participants who switched from bandage to cast therapy were kept in the bandage group for analysis purposes) |
Selective reporting (reporting bias) | Unclear risk | Trial registered prospectively in the Netherlands Trial Register. However, function was assessed only in terms of range of motion and the data for pain and discomfort were incompletely linked with the recording of these |
Other bias: major imbalance in baseline characteristics | Low risk | Quote: “Between the two randomisation groups no statistical significant difference was found in the demographic data” |
Other bias: performance bias | Unclear risk | No detail on expertise of healthcare personnel |
Other bias | Low risk | None detected |