Pulsed Ultrasound to Speed-up Healing after Intramedullary nailing of Tibia fractures

Completed

• Conditions: Closed or I° open fractures of the tibia; Injury, Occupational Diseases, Poisoning; Fracture of lower leg, including ankle

• Registration Number: ISRCTN90844675
• Lead Sponsor: German Employer's Liability Insurance for the Administrative Professions (Verwaltungs-Berufsgenossenschaft [VBG]) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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

1. Multiple injuries/polytrauma
2. Greater than I° open fractures
3. Pregnant or breastfeeding women
4. Pathological fractures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bony union three months (+/- 1 week) after randomisation, as assessed on plain radiographs by independent, blinded raters.

Secondary Outcome Measures

Name	Time	Method
1. Delayed union and non-union rates<br>2. Health-related quality of life (36-item Short Form Health Survey [SF-36], EuroQoL instrument [EQ-5D])<br>3. Functional outcomes (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])<br>4. Duration of sick leave<br>5. Cost-utility<br>6. Serious adverse events (SAE)<br><br>Secondary outcomes will be assessed after 6 weeks, 3, 6, and 12 months.