NCT00667849

Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.

Detailed description

A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
DEVICE	Exogen 4000+	Low-intensity pulsed ultrasound (LIPUS)
DEVICE	Sham	sham device identical to active device with the exception of administration of ultrasound

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-04-28
• Last updated: 2015-12-08
• Results posted: 2015-12-08

Locations

16 sites across 2 countries: United States, Canada