Upstate study to test new device to treat moderate lumbar spinal stenosis
SYRACUSE, N.Y. SUNY Upstate Medical University researchers are participating in an FDA-approved, multi-site clinical trial to test the safety and effectiveness of an implantable device to treat moderate lumbar spinal stenosis. The FDA will evaluate the data collected from this study to determine whether the devicethe Superion Interspinous Spacer (ISS) should be made commercially available in the United States.
Principal investigator for the Upstate study is Richard A. Tallarico, M.D.; co-investigators are William F. Lavelle, M.D., and Mike H. Sun, M.D., of Upstate's Department of Orthopedic Surgery.
"Superion ISS is a potential alternative to traditional spinal surgery and has been designed to relieve leg, buttock and groin pain resulting from pressure on the spinal nerve roots that can develop from walking or standing for long periods," Tallarico said.
The Superion ISS is limited to investigational use within the United States. It belongs to a new category of treatments designed to relieve pressure on the compressed nerve roots while preserving the patient's anatomy and ability to maintain motion. The clinical trial will compare the effectiveness of Superion ISS to the X-STOP Interspinous Process Distraction Device, an FDA-approved interspinous spacer that is implanted in a slightly different manner.
"We are investigating whether Superion ISS may offer a minimally invasive alternative to spinal decompression surgery for some patients," Tallarico said. "The device is implanted through a single, half-inch incision. No bone and only minimal soft tissue are removed during the procedure."
Once implanted the device can act as a support column to open the passageways through which the nerve roots travel from the lumbar, or lower spine, to the legs. Superion ISS may help to widen these passageways, potentially resulting in relief of the pain caused by the compression of the nerve roots.
"We are recruiting individuals who are 45 years of age or older, who have been diagnosed with moderate lumbar spinal stenosis and whose symptoms include persistent leg, buttock and/or groin pain that is relieved by sitting or bending forward," Tallarico said.
Study volunteers must have experienced these symptoms for at least six months and cannot have a history of prior surgery of the lumbar spine.
Volunteers will have gone through at least six months of non-operative treatment before being eligible to enroll in the study. The treatment may include physical therapy, nerve block injections and oral medications.
Volunteers who meet the study criteria and agree to participate in the study will be randomly assigned to receive either the X-STOP IPD device or the Superion ISS. They will be evaluated at specific follow-up visits for 24 months following their surgery.
A patient will be declared a clinical success if all conditions are met at the 24-month follow-up, including clinically significant improvement in outcomes compared to baseline, as determined by improvement in physical function and symptom severity and patient satisfaction scores.
To learn more about the study, visit superionstudy.com. To learn more about becoming a study volunteer, call 315-464-8618.