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. 2014 Jun 23;2014(6):CD008579. doi: 10.1002/14651858.CD008579.pub3

ISRCTN90844675.

Methods Randomised controlled multicentre trial
Participants Adults with closed or type I open fractures of the tibia that had been treated by reamed or unreamed locking intramedullary nails less than 10 days prior to randomisation. Patients with fractures of the lateral malleolus, fixed by plates, as well as patients with minor concomitant injuries (bruises, sprains) were offered trial participation.
Intended target population: 250
Interventions Test: pulsed, low‐energetic ultrasound (Exogen, Smith & Nephew), applied daily for three months
 Control: standard of care
Outcomes Follow‐up: 1 year
Primary: bony union three months (+/‐ 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters
Secondary (assessed after 6 weeks, 3, 6, and 12 months):
1. Delayed union and non‐union rates
 2. Health‐related quality of life (36‐item Short Form Health Survey [SF‐36], EuroQoL instrument [EQ‐5D])
 3. Functional outcomes (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])
 4. Duration of sick leave
 5. Cost‐utility
 6. Serious adverse events (SAE)
Notes Trial registration identified after preparation of the review. Indicated as a completed trial (01/10/2008 to 01/10/2010). Efforts to learn its current status were unsuccessful for the first version of this review but Dr Seifert indicated that data were under analysis during the update of the review. (Seifert 2013)
 Contact: Dr Julia Seifert, Berlin (julia.seifert@ukb.de)
We also found that the results may have been presented in an oral presentation but have not obtained a copy of this:
Froese E, Gümbel D, Stengel D. Pulsed ultrasound to speed healing after internal fixation of tibia fractures‐ Results from the randomized PUSH‐IT trial (ISRCTN90844675). 12th Congress European Forum For Research In Rehabilitation; 11‐14 September 2013, Istanbul Turkey.