Interested in investigating EXOGEN? We are currently seeking investigators for and enrolling patients in the following Investigational Device Exemption (IDE) FDA-regulated clinical trials. For more information, click on the study name.
This EXOGEN clinical trial will determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
To learn more about this and other EXOGEN clinical trials, visit ClinicalTrials.gov
Collaborator: Canadian Institutes of Health Research (CIHR)
Condition: Tibial fractures
Study type: Interventional
Primary purpose: Treatment
This EXOGEN clinical trial will determine whether using active low-intensity, pulsed ultrasound as adjunct therapy following single-level posterior-instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.
To learn more about this and other EXOGEN clinical trials, visit ClinicalTrials.gov
Condition: Lumbar Degenerative Disc Disease
Study type: Interventional
Primary purpose: Treatment
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*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions† excluding skull and vertebra.
In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.
There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080.
†A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
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