Trial to Evaluate UltraSound in the Treatment of Tibial Fractures

Not Applicable

Terminated

• Conditions: Tibial Fractures
• Interventions: Device: Exogen 4000+; Device: Sham

• Registration Number: NCT00667849
• Lead Sponsor: Bioventus LLC

Brief 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.

Study Timeline

• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-28
• Study Start: 2008-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2015-09-24
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-04
• Last Update Submitted: 2015-11-04
• Results First Posted: 2015-12-08
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exogen 4000+	Exogen 4000+	Single arm, Exogen 4000+
Sham	Sham	Single arm, sham (identical device with the exception of administration of ultrasound).

Primary Outcome Measures

Name	Time	Method
Time (Days) to Radiographic Healing of Tibial Fractures	over 365 days	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
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)	Over 365 days	Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best

Trial Locations

Locations (16)

Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

QE II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Orthopedic Specialtiy Associates; 🇺🇸 Fort Worth, Texas, United States

Insall Scott Kelly Institute; 🇺🇸 New York, New York, United States

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Vancouver Coastal Health; 🇨🇦 Vancouver, British Columbia, Canada

San Francisco General/Dept of Orthopedic Surgery; 🇺🇸 San Francisco, California, United States

Florida Orthopedic Institute; 🇺🇸 Tampa, Florida, United States

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States