Trial to Evaluate UltraSound in the Treatment of Tibial Fractures (TRUST)

Bioventus

Status: Terminated

Conditions: Tibial Fractures

Treatments: Device: Sham; Device: Exogen 4000+

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00667849

EX-TIB-0907

Details and patient eligibility

About

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

Full 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.

Enrollment: 501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females age 18 years or older
• Have an open or closed tibial fracture amenable to intramedullary nail fixation

Exclusion criteria

• Tibial fracture associated with a vascular injury requiring repair
• Pilon fractures
• Tibial fractures that extend into the joint and require reduction
• Pathologic fractures • Bilateral tibial fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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501 participants in 2 patient groups

Exogen 4000+

Active Comparator group

Description:

Single arm, Exogen 4000+

Treatment:

Device: Exogen 4000+

Sham

Sham Comparator group

Description:

Single arm, sham (identical device with the exception of administration of ultrasound).

Treatment:

Device: Sham