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Implant Survival Analysis and Failure Modes of the X-Stop Interspinous Distraction Device

Tuschel, Alexander MD, MSc; Chavanne, Albert MD; Eder, Claudia MD, PhD; Meissl, Michael MD; Becker, Philipp MD; Ogon, Michael MD

Spine:
doi: 10.1097/BRS.0b013e31820b86e1
Clinical Case Series
Abstract

Study Design. Retrospective cohort study.

Objective. To review the clinical outcome, implant survivorship and reasons for failure after X-Stop implantation.

Summary of Background Data. Conflicting data exist concerning clinical outcome of the X-Stop interspinous spacer and little information is being published about implant survivorship and the need for revision surgery.

Methods. This retrospective review evaluated 46 patients who underwent implantation of the X-Stop interspinous spacer for the treatment of neurogenic claudication. After a mean follow-up of 40 months, pain levels, 36-Item Short Form Health Survey (SF-36), Oswestry Disability Index (ODI), and the need for subsequent surgery were assessed and a Kaplan-Meier survivorship analysis was performed.

Results. Within the follow-up period, the revision rate was found to be 30.4%. Lack of improvement at 6-week follow-up correlated well with subsequent revision surgery, which predominantly took place within 12 months after the index surgery. In patients who did not need to undergo revision surgery, clinical outcome parameters improved significantly. Kaplan-Meier survivorship analysis predicted an implant survival probability of 0.68 at 48 months postoperatively.

Conclusion. Clinical outcome after X-Stop implantation might be considerably less favorable than when it was being published previously. Patient selection might be a reason for early revision surgery. More criteria for better X-Stop indications might be needed.

In Brief

Forty-six patients who underwent X STOP implantation for the treatment of neurogenic claudication were reviewed with a minimum follow-up of 24 months. A fairly high revision rate (30.4%), predominantly within the first 12 months, was observed. Patient selection might be a reason for early revision surgery. More criteria for better X STOP indications are needed.

Author Information

From the Orthopaedic Hospital Speising, Spine Center, Speisingerstrasse, Vienna, Austria.

Address correspondence and reprint requests to Alexander Tuschel, MD, MSc, Orthopaedic Hospital Speising, Spine Center, Speisingerstrasse 109, 1130 Vienna, Austria; E-mail: alexander.tuschel@oss.at

Acknowledgment date: July 13, 2012. First revision date: September 17, 2012. Second revision date: November 4, 2012. Acceptance date: November 9, 2012.

The Manuscript submitted does not contain information about medical device(s)/drug(s).

No funds were received in support of this work. No relevant financial activities outside the submitted work.

© 2013 by Lippincott Williams & Wilkins