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Richard Menger, M.D., MPA |
The USA Health Department of Neurosurgery has been selected as one of seven sites nationwide to participate in a study to collect data on the safety, performance and effectiveness of an innovative medical device in patients who have spinal fusion surgery with pelvic fixation/fusion.
The iFuse Bedrock Granite Implant System is intended to be used for sacroiliac (SI) joint fusion to address dysfunction, fractures, degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures of the spine, or a failed previous fusion, among other conditions.
The system, according to Richard Menger, M.D., MPA, a USA Health neurosurgeon and the chief of complex spine surgery, can offer positive benefits to patients.
“This is the leading edge of spinal deformity surgery. Typical lumbo-pelvic fusion involved instrumentation links the spine to the pelvis for stability, but this allows an actual fusion of the joint between the last part of the spine and the pelvis,” said Menger, who also is an associate professor of neurosurgery in the Frederick P. Whiddon College of Medicine. “This new technology has the significant potential to reduce pain and to make complex surgery safer.”
The study, Pelvic Fixation and Fusion During Multilevel Spinal Surgery, is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts across select centers in the United States.
Menger praised the collaborative effort with Stefanie White and Valerie Patterson, both of whom work with clinical trials, and Nate Stuck, a physician assistant in the Department of Neurosurgery. “It’s great to have that level of experience and knowledge here at USA,” he said.
“Our participation illustrates USA's growing academic footprint regionally and nationally,” Menger said. “Academic medicine can have a tremendous impact on the delivery of care. Our entire group of surgeons attend scientific conferences, present at scientific conferences, and now we are partnering with leading technology development to best help our patients and push the field forward.”