Abstract
A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80) or X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001). Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain decreased from 55 ± 27 mm at pretreatment to 22 ± 26 mm at 6 months in the Superion group (P < 0.001) and from 54 ± 29 mm to 32 ± 31 mm with X-STOP (P < 0.001). Extremity pain decreased from 61 ± 26 mm at pretreatment to 18 ± 27 mm at 6 months in the Superion group (P < 0.001) and from 64 ± 26 mm to 22 ± 30 mm with X-STOP (P < 0.001). Back function improved from 38 ± 13% to 21 ± 19% with Superion (P < 0.001) and from 40 ± 13% to 25 ± 16% with X-STOP (P < 0.001). Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care.
Highlights
Lumbar spinal stenosis (LSS) is defined as a narrowing of the lumbar spinal canal and/or the intervertebral foramina due to disc degeneration, bulging of the annulus, facet joint hypertrophy, and/or thickening of the ligamentum flavum [1,2,3]
Midterm results with newer devices suggest that interspinous spacers improve patient symptoms with rare reports of dislodgements [17, 18], longterm safety and effectiveness are unknown [19]. The purpose of this prospective, randomized, controlled trial was to compare 6-month clinical outcomes in patients treated with an investigational interspinous spacer versus those treated with a Food and Drug Administration- (FDA-) approved spacer
This paper describes the preliminary outcomes of the first 166 subjects enrolled in this clinical trial
Summary
Lumbar spinal stenosis (LSS) is defined as a narrowing of the lumbar spinal canal and/or the intervertebral foramina due to disc degeneration, bulging of the annulus, facet joint hypertrophy, and/or thickening of the ligamentum flavum [1,2,3]. The annual incidence of LSS is 5 per 100,000 people [5], and, in adults over the age of 65 years, LSS is the most common diagnosis in those who undergo spine surgery [6] Nonsurgical management options such as activity modification, physical therapy, anti-inflammatory drugs, and epidural steroid injections represent the standard of care for initial treatment of mild claudication symptoms. The long-term effectiveness of these nonsurgical treatments is limited, since none hinders the progression of the disease [7,8,9] This is supported by the fact that only 42% of patients treated with nonsurgical management for LSS report improvement in symptoms 10 years later [10]. The purpose of this prospective, randomized, controlled trial was to compare 6-month clinical outcomes in patients treated with an investigational interspinous spacer versus those treated with a Food and Drug Administration- (FDA-) approved spacer
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