On 15 November, DFine announced the initiation of a prospective randomised clinical study to evaluate the clinical effectiveness of minimally invasive augmentation procedures to treat vertebral compression fractures.
PRIORi-T (Prospective randomised investigation of radio frequency targeted vertebral augmentation) is a post-market, clinical study that will compare the radiofrequency targeted vertebral augmentation (RF-TVA) procedure to non-operative management (conservative care) in properly diagnosed osteoporotic vertebral compression fractures within six weeks of onset.
Treatment arm participants will undergo a minimally invasive procedure using the DFine StabiliT vertebral augmentation system, while the control arm will receive non-operative treatment (i.e. analgesics, bed rest, back braces, physiotherapy, rehabilitation programmes and walking aids), according to current standard of practice of participating centres.
Up to 130 patients, 22 to 90 years of age will be randomised to receive either RF-TVA or non-operative treatment in a 1:1 ratio at up to 15 centres. Patients will be followed for 12 months. The primary endpoint is the improvement in pain from baseline at one-month. Key secondary endpoints include change in narcotic and analgesic usage, disability and quality of life over the course of the study.
“This is an important study for refining the standard of care for acute vertebral body compression fractures. Initiating this prospective randomised post-market study evaluating minimally invasive procedures versus conservative care to treat painful vertebral compression fractures with the StabiliT system demonstrates Dfine’s commitment to evidence-based medicine,” said Allan L Brook, director of interventional neuroradiology and professor of clinical radiology and neurosurgery at Montefiore Medical Center and the study principal investigator.
Initial participating sites include Albert Einstein School of Medicine (Montefiore Medical Center) in New York, Stanford Medical Center in Palo Alto, California, Baylor University Medical Center in Dallas, Texas, Dartmouth-Hitchcock Medical School in Hanover and the Mayo Clinic in Scottsdale, Arizona.
“StabiliT is the most advanced, targeted therapy for the treatment of vertebral compression fractures available today,” said Kevin Mosher, DFine’s CEO. “The combination of RF technology, navigational instrumentation and ultra-high viscosity cement enables physicians 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 RF-TVA for patients suffering from debilitating back pain caused by osteoporotic vertebral compression fractures.”
DFine received 510(k) clearance and commercially introduced the StabiliT system in 2008. To date, more than 6,000 cases of spinal fractures have been treated with StabiliT worldwide.