Mayr 2000.
| Methods | Randomised controlled trial | |
| Participants | Setting: German emergency outpatient department. Single‐centre study. Size: 29 patients, 30 fractures; 15 fractures in each group. Baseline characteristics: mean age (SD) age 37 (14) years; 5 to 1 male / female ratio. Inclusion: skeletally mature adults with a fresh stable scaphoid fracture (AO B1 and B2). Exclusion: unstable fractures, generalised skeletal disease, pathological fracture, fracture more than 10 days old at diagnosis. |
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| Interventions | A forearm plaster splint was applied to include the thumb to the interphalangeal joint. After detumescence, the splint was replaced with a circular restraining forearm bandage to include the thumb to the interphalangeal joint. Test: after appliance of the circular immobilising forearm bandage, daily 20‐minute pulsed low‐intensity ultrasound treatment (SAFHS, Exogen, Piscataway, NJ, USA; frequency: 1.5 MHz, pulsed with 1 kHz, signal length: 200 µsec, intensity: 30 mW/cm²) was conducted. Control: no additional placebo treatment. |
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| Outcomes | Follow‐up schedule: CT at 6 weeks and then every 2 weeks until union.
Primary outcome: time to union by CT assessment of fracture union. Secondary outcome: percentage of ossification of the fracture gap. |
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| Notes | The follow‐up schedule was changed after 6 patients had been scanned at 6 weeks, when 3 of them had already achieved union. From that point onwards in the trial, first follow‐up was at 4 weeks. Translated from German. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sequence generated by a random number generator. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Blinding (performance bias and detection bias) Objective measures | Low risk | CT scans were blinded before reporting by a panel of independent radiologists and surgeons. |
| Incomplete outcome data (attrition bias) Objective measures | Low risk | There was no loss of outcome data. |
| 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 is not reported. |