In This SectionTexas Health Research & Education Institute
Disease or Condition
Orthopedics / Fracture Repair
Trial to evaluate Ultrasound in the Treatment of tibial Fractures (Orthopedics / Fracture Repair)
This multi-center study is a prospective, blinded, randomized placebo-treatment controlled trial comparing the safety and effectiveness of the use of low intensity pulsed ultrasound in the treatment of tibial fractures treated with intramedullary nailing.
Males and females age 18 years or older.
Have an open (Gustillo Grade I - IIIb ) or closed (Tscherne Grade 0 or equall to 3) tibial fracture, amenable to intramedullary nail fixation in the opinion of the attending surgeon for open fractures.
Debridement must have taken place within 24 hours of presentation to the trauma center or emergency department.
Provide written informed consent for trial participation and initiate treatment with the device within 14 days of definitive treatment with intramedullary nail of the tibia fracture.
Be willing and able to comply with the study protocol including return for all follow up evaluations.
Circumferential, open wound that precludes placement of ultrasound at the fracture site.
General wound care that precludes ultrasound skin contact (e.g. coverage of awound that cannot be modified to allow for skin contact).
Tibial fracture associated with a vascular injury requiring repair (Gustillo Grade IIIc injuries).
Tibial fractures that extend into the joint and require reduction.
Pathologic fractures (defined as chronic infection, chronic osteomyelitis, etc.).
Bilateral tibial fractures.
Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the subject’s tibial fracture.
Segmental fractures that are separated by more than 3 inches, and spiral fractures Formatted: Bullets and Numbering that extend for longer than 3 inches in length along the tibia.
Use of an external fixation device or plate as definitive treatment.
Surgical delay of definitive treatment > 2 week.
Tibial fractures that show less than 25% cortical contact and > 1cm gap following intramedullary nail fixation.
There are likely to be problems, in the judgment of the Investigator or Research Coordinator, with maintaining follow up (such as no fixed address, plans to move out of town in the next year, etc.).
Subject is already making use of therapeutic ultrasound at the fracture site.
Subject is participating in another research study.
Subject is implanted with bone morphogenic protein(s) or other osteobiologic at the site of the tibial fracture, or use of osteobiologics is planned.
Subject is using electrical stimulation at the site of the tibial fracture Cognitive impairment or language difficulties that would impede the valid completion of questionnaires.
Women who are pregnant or nursing or plan to become pregnant during their treatment period.
Prisoners, Subject is a prisoner or is at high risk of incarceration during the follow up period.
Subjects with active implantable devices, such as cardiac pacemakers.
Subject states they cannot comply with the study protocol.