• J Spinal Disord Tech · Feb 2013

    Clinical Trial

    Two-year results of X-stop interspinous implant for the treatment of lumbar spinal stenosis: a prospective study.

    • Anjali Nandakumar, Natasha A Clark, Francis W Smith, and Douglas Wardlaw.
    • NHS Grampian and University of Aberdeen, Department of Orthopaedics, Positional MRI Centre, Woodend Hospital, Aberdeen, Scotland, UK. anjalinandakumar@yahoo.co.uk
    • J Spinal Disord Tech. 2013 Feb 1;26(1):1-7.

    Study DesignProspective Observational Study.ObjectiveTo prospectively assess the clinical outcome of patients treated for symptomatic spinal stenosis with the X-stop device.Summary Of Background DataThe X-stop device is used in the treatment of symptomatic lumbar spinal stenosis. The preliminary results of this study of 40 patients at 1 year were published in 2007. The 2-year results of 57 patients are reported in this paper. Zucherman et al report 60% significant improvement at 1 year and 48.4% at 2 years.MethodsFifty-seven consecutive patients with radiologically confirmed lumbar spinal stenosis were enrolled and treated with the X-stop device. The device was implanted at a maximum of 2 affected levels. Clinical response was evaluated with the Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index, and Short Form-36 questionnaires preoperatively and 6, 12, and 24 months postoperatively.ResultsOf the 57 patients enrolled, 54 completed the ZCQ questionnaire at 1 year and 46 patients at 2 years. Clinically significant improvement was attained by 65% at 1 year and 57% at 2 years and 70% were satisfied with the outcome of the surgery. Single level and double level insertions did not have significant difference in clinical outcome.ConclusionThis study demonstrates with the use of ZCQ scores as primary outcome measures that improved clinical outcomes are maintained at 2 years after X-stop implantation.

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