A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational\ninterspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with\nmoderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80)\nor X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication\nQuestionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar\nchanges were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001).\nMean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that\nachieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain\ndecreased from 55 �± 27mm at pretreatment to 22 �± 26mm at 6 months in the Superion group (P < 0.001) and from 54 �± 29mm\nto 32 �± 31mm with X-STOP (P < 0.001). Extremity pain decreased from 61 �± 26mm at pretreatment to 18 �± 27mm at 6 months\nin the Superion group (P < 0.001) and from 64 �± 26mm to 22 �± 30mm with X-STOP (P < 0.001). Back function improved from\n38 �± 13% to 21 �± 19% with Superion (P < 0.001) and from 40 �± 13% to 25 �± 16% with X-STOP (P < 0.001). Preliminary results\nsuggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients\nwith moderate LSS who are unresponsive to conservative care.
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