Clinical trial NCT00667849: Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Official title: Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tibial Fractures
Keywords: Tibia
Lead sponsor: Bioventus LLC
Sponsor class: INDUSTRY
Collaborators: name: McMaster University
name: Clinical Advances Through Research and Information Translation
First posted: 2008-04-28
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
timeFrame: Over 365 days
measure: Time (Days) to Radiographic Healing of Tibial Fractures
timeFrame: over 365 days
Secondary outcomes:
Other outcomes:
measure: Treatment Compliance
timeFrame: Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)
Locations:
city: San Francisco
country: United States
facility: San Francisco General/Dept of Orthopedic Surgery
state: California
city: Tampa
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: New York
country: United States
facility: Insall Scott Kelly Institute
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Fort Worth
country: United States
facility: Orthopedic Specialtiy Associates
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findakli F, Busse JW, Schemitsch EH, Lonn E, Farrokhyar F, Bhandari M; and the TRUST Investigators. Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study. Clin Orthop Relat Res. 2021 Apr 1;479(4):805-813. doi: 10.1097/CORR.0000000000001573.
citation: TRUST Investigators writing group; Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, Leung KS, Heels-Ansdell D, Makosso-Kallyth S, Della Rocca GJ, Jones CB, Guyatt GH. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016 Oct 25;355:i5351. doi: 10.1136/bmj.i5351.
citation: Busse JW, Bhandari M, Einhorn TA, Heckman JD, Leung KS, Schemitsch E, Tornetta P 3rd, Walter SD, Guyatt GH. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014 Jun 4;15:206. doi: 10.1186/1745-6215-15-206.
citation: Dijkman BG, Busse JW, Walter SD, Bhandari M; TRUST Investigators. The impact of clinical data on the evaluation of tibial fracture healing. Trials. 2011 Nov 3;12:237. doi: 10.1186/1745-6215-12-237.