Handolin 2005a.
| Methods | Randomised, placebo‐controlled study | |
| Participants | Setting: Helsinki Unversity Central Hospital, Finland. Size: 22 patients, 11 in each arm. Baseline characteristics: mean (range) age 37.5 years (18 to 54), 9 males and 2 females in intervention group. Mean (range) age 45.5 years (26 to 59), 6 males and 5 females in the control group. Inclusion criteria: patients aged between 18 and 65 years with displaced Weber B fractures of the lateral malleolus. Exclusion criteria: widening of the distal tibiofibular joint; open fracture; inability to co‐operate with the requirements of the trial. |
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| Interventions | Participants underwent open reduction and internal fixation with a 4.5 mm self‐reinforced poly‐L‐lactic acid screw. Surgery was carried out by one of two surgeons. The fracture was approached through a lateral incision. Post‐operatively the ankle was immobilised for six weeks with a removable Soft Cast brace. Partial weight bearing was allowed at two weeks and full weight bearing at four weeks. Test: participants self‐administered daily ultrasound treatment for 20 minutes from the third to ninth post‐operative weeks directly over the fracture marked with an intra‐operatively placed marker. Appropriate contact between the probe and the skin was maintained with standard ultrasound coupling gel. The ultrasound signal was composed of a 200 µs burst of 1.5 MHz sine waves, with a repetition rate of 1 kHz and a spatial average intensity of 30 mW/cm². Control: participants in the control group were given a similar treatment regimen but had an externally similar sham machine instead. |
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| Outcomes | Fracture healing was assessed by anterior and lateral radiographs taken immediately and at 2, 6, 9 and 12 weeks postoperatively In addition, fracture healing was assessed by multiplanar computed tomography and 2 and 9 weeks postoperatively |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "..prospective, randomized, double‐blind and placebo controlled study". No comment on sequence generation. |
| Allocation concealment (selection bias) | Low risk | Quote: "The patients were randomly provided with either an active or sham ultrasound device in a double‐blind manner". |
| Blinding (performance bias and detection bias) Objective measures | Unclear risk | Quote: "The patients were randomly provided with either an active or sham ultrasound device in a double‐blind manner". Comment: Likely to be the same device but placebo devices were deactivated. |
| Incomplete outcome data (attrition bias) Objective measures | Low risk | "One patient was excluded... because of a new injury" but the group to which he was randomised is unreported |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No additional biases identified |
| Selection bias (imbalance in baseline characteristics) | Unclear risk | Smoking status not reported |