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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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Related in: MedlinePlus

(A) A/P and (B) lateral radiographic image showing a properly placedSuperion Interspinous Spacer.
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Figure 1: (A) A/P and (B) lateral radiographic image showing a properly placedSuperion Interspinous Spacer.

Mentions: Patients were randomized to treatment with the Superion Interspinous Spacer(VertiFlex, Inc., San Clemente, CA, USA) or a Control spacer (X-StopInterspinous Process Decompression System; Medtronic, Inc., Sunnyvale, CA, USA).The Superion device (Figure 1A and 1B) is an investigational device that is composed of titanium6AI-4 V ELI alloy, a material that conforms to ASTM standards for surgicalimplants and commonly used in a variety of orthopedic applications [9]. Five device sizes are available, ranging from 8 to 16 mm, witheach size corresponding to the magnitude of desired distraction between the twospinous processes. This single-piece, self-expanding implant is delivered viaminimally invasive access and deployed between the spinous processes of theinvolved vertebral levels. The Control spacer was approved for use in the UnitedStates by the FDA in November 2005 [10]. Procedural details have been described elsewhere [11]. Interspinous spacers were implanted at 1 (51%) or 2 (49%) levels,with a comparable distribution between groups.


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)

(A) A/P and (B) lateral radiographic image showing a properly placedSuperion Interspinous Spacer.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 1: (A) A/P and (B) lateral radiographic image showing a properly placedSuperion Interspinous Spacer.
Mentions: Patients were randomized to treatment with the Superion Interspinous Spacer(VertiFlex, Inc., San Clemente, CA, USA) or a Control spacer (X-StopInterspinous Process Decompression System; Medtronic, Inc., Sunnyvale, CA, USA).The Superion device (Figure 1A and 1B) is an investigational device that is composed of titanium6AI-4 V ELI alloy, a material that conforms to ASTM standards for surgicalimplants and commonly used in a variety of orthopedic applications [9]. Five device sizes are available, ranging from 8 to 16 mm, witheach size corresponding to the magnitude of desired distraction between the twospinous processes. This single-piece, self-expanding implant is delivered viaminimally invasive access and deployed between the spinous processes of theinvolved vertebral levels. The Control spacer was approved for use in the UnitedStates by the FDA in November 2005 [10]. Procedural details have been described elsewhere [11]. Interspinous spacers were implanted at 1 (51%) or 2 (49%) levels,with a comparable distribution between groups.

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