BACKGROUND: To alleviate the symptoms of lumbar spinal stenosis, widely accepted methods of surgical treatment include decompression alone and decompression with fusion. As an alternative to these methods, interlaminar stabilization (ILS) devices with decompression were introduced. There is a large amount of research dedicated to examining the efficacy of ILS devices in single-level procedures, but fewer studies focus on their efficacy in 2-level procedures. The purpose of this study was to compare decompression with instrumented posterolateral fusion to decompression with interlaminar stabilization in patients who require surgical treatment at 2 levels for lumbar spinal stenosis at 5 years postoperation. METHODS: Of the 322 patients enrolled in the Investigational Device Exemption clinical trial, 116 required surgical treatment at 2 levels. The ILS group consisted of 77 patients, and the fusion group consisted of 39 patients. Efficacy was measured using composite clinical success (CCS). Patients achieve CCS if they achieve all 4 of the following outcomes: ≥15-point improvement from baseline Oswestry Disability Index (ODI); no reoperation or epidural injections; no persistent, new, or increasing neurological deficits; and no major device-related complications. RESULTS: There was a 91% rate of follow-up within the participant population in the 5-year data. There was a difference trending toward significance between groups for the absence of reoperation or epidural injection, with 68.8% of ILS patients and only 51.3% of fusion patients meeting this criteria (P = .065); 13.0% of ILS patients and 25.7% of fusion patients required secondary surgery. The percentage of patients achieving overall CCS was much greater in the ILS group than the fusion group, with 55.1% (38/69) of ILS patients and only 36.4% (12/33) of fusion patients achieving CCS at month 60 (P = .077). With regard to the ODI, the visual analog scale back and worse leg pain, the Short Form-12, and the Zurich Claudication Questionnaire, both groups had significantly better results at every follow-up time point when compared to their respective baseline scores. CONCLUSIONS: The 2-level ILS patient group performed as well as, if not better than, the 2-level fusion group across almost all outcome measures, demonstrating both clinical outcome success and favorably low reoperation rates in patients who received ILS surgery. CLINICAL RELEVANCE: This is the first 5-year analysis of the 2-level ILS experience, which supplements previous studies that describe the advantages of ILS by extending such advantages to 2-level cases.
BACKGROUND: To alleviate the symptoms of lumbar spinal stenosis, widely accepted methods of surgical treatment include decompression alone and decompression with fusion. As an alternative to these methods, interlaminar stabilization (ILS) devices with decompression were introduced. There is a large amount of research dedicated to examining the efficacy of ILS devices in single-level procedures, but fewer studies focus on their efficacy in 2-level procedures. The purpose of this study was to compare decompression with instrumented posterolateral fusion to decompression with interlaminar stabilization in patients who require surgical treatment at 2 levels for lumbar spinal stenosis at 5 years postoperation. METHODS: Of the 322 patients enrolled in the Investigational Device Exemption clinical trial, 116 required surgical treatment at 2 levels. The ILS group consisted of 77 patients, and the fusion group consisted of 39 patients. Efficacy was measured using composite clinical success (CCS). Patients achieve CCS if they achieve all 4 of the following outcomes: ≥15-point improvement from baseline Oswestry Disability Index (ODI); no reoperation or epidural injections; no persistent, new, or increasing neurological deficits; and no major device-related complications. RESULTS: There was a 91% rate of follow-up within the participant population in the 5-year data. There was a difference trending toward significance between groups for the absence of reoperation or epidural injection, with 68.8% of ILS patients and only 51.3% of fusion patients meeting this criteria (P = .065); 13.0% of ILS patients and 25.7% of fusion patients required secondary surgery. The percentage of patients achieving overall CCS was much greater in the ILS group than the fusion group, with 55.1% (38/69) of ILS patients and only 36.4% (12/33) of fusion patients achieving CCS at month 60 (P = .077). With regard to the ODI, the visual analog scale back and worse leg pain, the Short Form-12, and the Zurich Claudication Questionnaire, both groups had significantly better results at every follow-up time point when compared to their respective baseline scores. CONCLUSIONS: The 2-level ILS patient group performed as well as, if not better than, the 2-level fusion group across almost all outcome measures, demonstrating both clinical outcome success and favorably low reoperation rates in patients who received ILS surgery. CLINICAL RELEVANCE: This is the first 5-year analysis of the 2-level ILS experience, which supplements previous studies that describe the advantages of ILS by extending such advantages to 2-level cases.
Authors: James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna N A Tosteson; Emily Blood; Brett Hanscom; Harry Herkowitz; Frank Cammisa; Todd Albert; Scott D Boden; Alan Hilibrand; Harley Goldberg; Sigurd Berven; Howard An Journal: N Engl J Med Date: 2008-02-21 Impact factor: 91.245
Authors: Michael J Musacchio; Carl Lauryssen; Reginald J Davis; Hyun W Bae; John H Peloza; Richard D Guyer; Jack E Zigler; Donna D Ohnmeiss; Scott Leary Journal: Int J Spine Surg Date: 2016-01-26
Authors: Urvij Modhia; Steven Takemoto; Mary Jo Braid-Forbes; Michael Weber; Sigurd H Berven Journal: Spine (Phila Pa 1976) Date: 2013-04-01 Impact factor: 3.468
Authors: Vikas V Patel; Peter G Whang; Thomas R Haley; W Daniel Bradley; Pierce D Nunley; Raphael P Davis; Larry E Miller; Jon E Block; Fred H Geisler Journal: Spine (Phila Pa 1976) Date: 2015-03-01 Impact factor: 3.468
Authors: Björn H Strömqvist; Svante Berg; Paul Gerdhem; Ragnar Johnsson; Anders Möller; Tage Sahlstrand; Ahmed Soliman; Tycho Tullberg Journal: Spine (Phila Pa 1976) Date: 2013-08-01 Impact factor: 3.468