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Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis.

Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH - BMC Musculoskelet Disord (2014)

Bottom Line: Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001).Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.NCT00692276.

View Article: PubMed Central - HTML - PubMed

Affiliation: The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA. jonblock@jonblockgroup.com.

ABSTRACT

Background: Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion(®) (Experimental) or the X-Stop(®), a FDA-approved interspinous spacer (Control).

Methods: A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment. Complication data were available for all patients and patient-reported outcomes were available for 192 patients (101 Experimental, 91 Control) at 2 years.

Results: Zurich Claudication Questionnaire (ZCQ) Symptom Severity and Physical Function scores improved 34% to 36% in both groups through 2 years (all p < 0.001). Patient Satisfaction scores at 2 years were 1.8 ± 0.9 with Experimental and 1.6 ± 0.8 with Control. Axial pain decreased from 59 ± 26 mm at baseline to 21 ± 26 mm at 2 years with Experimental and from 55 ± 26 mm to 21 ± 25 mm with Control (both p < 0.001). Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001). Back function assessed with the Oswestry Disability Index similarly improved with Experimental (37 ± 12% to 18 ± 16%) and Control (39 ± 12% to 20 ± 16%) (both p < 0.001). Freedom from reoperation at the index level was 84% for Experimental and 83% for Control (log-rank: p = 0.38) at 2 years.

Conclusions: Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.

Trial registration: NCT00692276.

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ZCQ patient satisfaction scores through 2 yearspost-treatment. Values are mean ± 95% CI.
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Figure 4: ZCQ patient satisfaction scores through 2 yearspost-treatment. Values are mean ± 95% CI.

Mentions: ZCQ symptom severity scores improved 36% with Experimental and 34% with Controlthrough 2 years (both p < 0.001; p = 0.60between groups) (Figure 2). Similar changes werenoted in ZCQ physical function with improvements of 36% with Experimental and35% with Control (both p < 0.001; p = 0.54 betweengroups) (Figure 3). The mean ZCQ patient satisfactionscore ranged from 1.6 to 1.9 in both groups at all follow-up visits(Figure 4).


Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis.

Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH - BMC Musculoskelet Disord (2014)

ZCQ patient satisfaction scores through 2 yearspost-treatment. Values are mean ± 95% CI.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4109165&req=5

Figure 4: ZCQ patient satisfaction scores through 2 yearspost-treatment. Values are mean ± 95% CI.
Mentions: ZCQ symptom severity scores improved 36% with Experimental and 34% with Controlthrough 2 years (both p < 0.001; p = 0.60between groups) (Figure 2). Similar changes werenoted in ZCQ physical function with improvements of 36% with Experimental and35% with Control (both p < 0.001; p = 0.54 betweengroups) (Figure 3). The mean ZCQ patient satisfactionscore ranged from 1.6 to 1.9 in both groups at all follow-up visits(Figure 4).

Bottom Line: Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001).Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.NCT00692276.

View Article: PubMed Central - HTML - PubMed

Affiliation: The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA. jonblock@jonblockgroup.com.

ABSTRACT

Background: Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion(®) (Experimental) or the X-Stop(®), a FDA-approved interspinous spacer (Control).

Methods: A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment. Complication data were available for all patients and patient-reported outcomes were available for 192 patients (101 Experimental, 91 Control) at 2 years.

Results: Zurich Claudication Questionnaire (ZCQ) Symptom Severity and Physical Function scores improved 34% to 36% in both groups through 2 years (all p < 0.001). Patient Satisfaction scores at 2 years were 1.8 ± 0.9 with Experimental and 1.6 ± 0.8 with Control. Axial pain decreased from 59 ± 26 mm at baseline to 21 ± 26 mm at 2 years with Experimental and from 55 ± 26 mm to 21 ± 25 mm with Control (both p < 0.001). Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001). Back function assessed with the Oswestry Disability Index similarly improved with Experimental (37 ± 12% to 18 ± 16%) and Control (39 ± 12% to 20 ± 16%) (both p < 0.001). Freedom from reoperation at the index level was 84% for Experimental and 83% for Control (log-rank: p = 0.38) at 2 years.

Conclusions: Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.

Trial registration: NCT00692276.

Show MeSH
Related in: MedlinePlus