San Francisco-based St. Mary's Medical Center has been selected to participate in an FDA study of Premia Spine's TOPS System.
Here are five things to know:
1. St. Mary's Medical Center is one of 30 U.S. spine centers selected to evaluate the efficacy and safety of the TOPS System compared to traditional lumbar fusion.
2. Participants in the investigational device exemption study will either undergo surgery with the TOPS System or undergo a lumbar spinal fusion. Patients are randomly placed into one of the groups with a 67 percent chance of undergoing surgery with the Premia device.
3. The device is designed to allow two vertebrae to continue moving instead of permanently locking them together with a fusion.
4. If approved, TOPS may be the first posterior arthroplasty device for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.
5. Study participants must have, any of the following:
- Radiating leg pain
- Greater leg or buttock pain than back pain
- Severe pain after walking as little as 100 yards or 2 minutes
- Pain that reduces when sitting, bending or leaning forward