DFine, a developer of minimally invasive radiofrequency targeted therapies, has begun a prospective and randomised study to investigate the clinical effectiveness of minimally invasive augmentation procedures in the treatment of vertebral compression fractures.
The trial includes 130 patients, and will compare radiofrequency targeted vertebral augmentation procedures with non-operative management in patients diagnosed with vertebral compression fractures within six weeks of onset.
Treatment arm participants will be implanted with DFINE StabiliT vertebral augmentation system, while the control arm will receive a non-operative treatment.
The primary endpoint of the study is an improvement in pain from baseline at one month, while secondary endpoints include change in narcotic and analgesic usage, disability and quality of life throughout the study.
DFine CEO Kevin Mosher said the integration of radiofrequency technology, navigational instrumentation and StabiliT ER2 cement enables clinicians to provide targeted fracture care with minimal damage to native bone and greater precision in cement delivery.
''We look forward to engaging many of the leading clinicians in the field to further validate the clinical effectiveness of radiofrequency targeted vertebral augmentation for patients suffering from debilitating back pain caused by osteoporotic vertebral compression fractures," Mosher added.