Pulsed ultrasound to speed-up healing after intramedullary nailing of tibia fractures (PUSH-IT)

INTERVENTION: Experimental: pulsed, low‐energetic ultrasound (Exogen, Smith & Nephew), applied daily for three months Control: standard of care The total duration of follow‐up is one year after randomisation. CONDITION: Closed or I° open fractures of the tibia ; Injury, Occupational Diseases, Poisoning ; Fracture of lower leg, including ankle PRIMARY OUTCOME: Bony union three months (+/‐ 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters. SECONDARY OUTCOME: 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); ; Secondary outcomes will be assessed after 6 weeks, 3, 6, and 12 months. INCLUSION CRITERIA: 1. Men and women 2. Greater than 18 years old 3. With closed or 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) will be offered trial participation.