Closed or I° open fractures of the tibia Injury, Occupational Diseases, Poisoning Fracture of lower leg, including ankle
Conditions
Interventions
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.
Sponsors
German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Multiple injuries/polytrauma 2. Greater than I° open fractures 3. Pregnant or breastfeeding women 4. Pathological fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bony union three months (+/- 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed