Emami 1999.
Methods | Randomised, placebo‐controlled study. | |
Participants | Setting: Uppsala University Hospital, Sweden. Size: 30 participants in total, with 15 in each arm. Baseline characteristics: mean (range) age 39 years (19 to 73), 21 males and 9 females. Inclusion criteria: patients aged over 16 years with a closed or Gustillo and Anderson grade I open fracture of the tibial diaphysis treated with closed reduction and fixation with a reamed, intra‐medullary, locked nail. Exclusion criteria: history of alcohol or drug dependency; current steroid, anticoagulant, NSAID or bisphosphonate use; past medical history of neuropathy, arthritis, malignant disease; radiographs that showed severe comminution or open physes. |
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Interventions | Participants underwent closed reduction and reamed, intramedullary nailing of the fracture. Surgery was performed by one of six experienced trauma surgeons. The fracture site was marked with a permanent skin marker.
Test: ultrasound treatment was started within three days of fixation and was continued for 75 days. The treatment consisted of one 20‐minute period daily with a maximum exposure of 25 hours. The transducer head was coupled to the skin with a standard 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: sham ultrasound treatment was started within three days of fixation and was continued for 75 days. The treatment consisted of one 20‐minute period daily with a maximum exposure of 25 hours. The sham device was a deactivated, identical model to that provided to the test group. |
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Outcomes | Follow‐up schedule: every third week until union. Additional follow‐up at 26 and 52 weeks irrespective of union status. Primary: time to radiographic union. Secondary: time to first radiographic evidence of callus, proportion of fractures united at six months, adverse events. |
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Notes | Outcomes were assessed by a single‐blinded radiologist and an orthopaedic surgeon independently, but were not pooled. The data used in this review are derived from the single independent radiologist. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The study was ... randomized" Comment: No specific report of how the sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | The allocation method was not reported. |
Blinding (performance bias and detection bias) Objective measures | Low risk | Quotes: "The codes were not broken for any device until the radiographic reviews for all patients had been completed." "...devices were identical in every way..." Comment: All measures were adequately blinded. |
Incomplete outcome data (attrition bias) Objective measures | Unclear risk | Quote: "In one patient, it became obvious during the course of the study that he did not fulfil the inclusion/exclusion criteria." Comment: No data were reported for this single participant and he was excluded from the analysis. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Low risk | No other bias detected. |
Selection bias (imbalance in baseline characteristics) | Low risk | Baseline data for age, sex and smoking status are reported and show a balanced distribution of these confounders between groups. |