X-STOP^®IPD^® System: Clinical Study Results

The X-STOP^® IPD^® System was tested in a carefully controlled research study that took place in nine hospitals across the United States. In this study, 100 patients with lumbar spinal stenosis had surgery with the X-STOP^® IPD^® Device. These patients were compared to 91 patients who did not have surgery, but were treated by their doctors in other ways (for example, with medications, corsets, physical therapy, etc.).

Approximately half of the patients who received the X-STOP^® IPD^® Procedure in this two-year research study experienced a degree of pain relief and ability to increase their activity levels that was sufficient to be considered a successful outcome at two years after the surgery. The clinical benefit beyond two years has not been measured.

The likelihood of needing an additional operation during the study was low. During the study, 6% of patients did not have a satisfactory treatment outcome and decided to have a laminectomy operation (removal of part of the vertebra in the spine), at which time the X-STOP^® IPD^® Device was removed. In addition, the implant dislodged (moved out of proper position) in one patient after a fall, and the implant was later removed. A second operation was also required in three other X-STOP^® IPD^® patients for the following conditions: drainage of a collection of blood, drainage of fluid around the wound, and removal of damaged tissue with secondary closure of the wound (allowing the wound to close on its own).

Please talk with your physician for more details about the clinical study and its results.

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Zucherman, J.F., et al., A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine. 2005;30(12):1351-1358.