Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Bioventus LLC501 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

501

Conditions

Tibial Fractures

Interventions

Exogen 4000+DEVICE

Low-intensity pulsed ultrasound (LIPUS)

ShamDEVICE

sham device identical to active device with the exception of administration of ultrasound

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

San Francisco General/Dept of Orthopedic Surgery

San Francisco, California, United States

Florida Orthopedic Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)

Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best

Time frame: Over 365 days

Time (Days) to Radiographic Healing of Tibial Fractures

Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier

Time frame: over 365 days

Data from ClinicalTrials.gov

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