Review of Clinical Studies for X-STOP

There are currently only a limited number of relatively short term clinical studies based on small study populations available to evaluate the effectiveness of the X-STOP in long term symptomatic relief.

This article presents a distillation of the clinical trial results available to date, highlighting several areas that have been established and several areas where the results are contradictory and/or not conclusive.

Review of the available studies at the time of this article suggests the following:

  • The X-stop procedure is a safe treatment for lumbar spinal stenosis, and the risk of significant surgical complications is small.
  • The procedure demonstrated superior relief of symptoms compared to non-operative treatment based on validated outcome measures with post operative follow up between 1 and 4 years. The benefits of the X-STOP procedure were demonstrated in reduction of pain, improved function, and improved quality of life.
  • The percent of patients who had the procedure and reported good satisfaction ranges in the 70-78% up to four years after the procedure. Currently, there is no published long term data available for follow up more than 4 years.
  • However, some studies report significantly reduced success rates for X-stop treated patients – e.g. less than 50% of patients in the study reported pain relief. This is particularly true for patients in the studies who had spondylolisthesis (slipped vertebra).
  • The currently available clinical literature offers a relatively wide range of surgical success rates.
  • There are no good studies currently available that directly compare the X-stop procedure to the traditional surgical treatment for spinal stenosis, a decompressive laminectomy (an open decompression). Some of the available studies seem to suggest comparable surgical outcomes in the short term (up to 4 years.)

In addition to knowing about clinical trial success rates, when making a decision about the X-STOP it is important for patients to also talk with their surgeon about the individual surgeon’s success rates in treating patients with similar symptoms and clinical presentation of lumbar stenosis, as results vary both among surgeons and for different clinical situations.

Further Reading: What Is Spinal Stenosis?