Wouter A Moojen1,2, Mark P Arts3, Wilco C H Jacobs4, Erik W van Zwet5, M Elske van den Akker-van Marle6, Bart W Koes7, Carmen Lam Vleggeert-Lankamp8, Wilco C Peul9,10. 1. Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands. w.a.moojen@lumc.nl. 2. Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands. w.a.moojen@lumc.nl. 3. Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands. m.arts@mchaaglanden.nl. 4. Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands. w.c.h.jacobs@lumc.nl. 5. Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands. e.w.van_zwet@lumc.nl. 6. Department of Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands. m.e.van_den_akker-van_marle@lumc.nl. 7. Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands. b.koes@erasmusmc.nl. 8. Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands. cvleggeert@lumc.nl. 9. Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands. w.c.peul@lumc.nl. 10. Department of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands. w.c.peul@lumc.nl.
Abstract
PURPOSE:Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated withIPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. METHODS: A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden-The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwentspinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. RESULTS: At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57-78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48-71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p < 0.01). Furthermore, long-term VAS back pain was significantly higher [36mm on a 100 mm scale (95 % CI 24-48)] in the IPD group compared to the bony decompression group [28 mm (95 % CI 23-34) p value 0.04]. CONCLUSIONS: This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional 'simple' decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm.
RCT Entities:
PURPOSE: Interspinous process devices (IPDs) are implanted to treat patients with intermittent neurogenic claudication (INC) based on lumbar spinal stenosis. It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery, an equal outcome after 2 years and less back pain compared with bony decompression. METHODS: A randomized design with variable block sizes was used, with allocations stratified according to center. Allocations were stored in prepared opaque, coded and sealed envelopes, and patients and research nurses were blind throughout the follow-up. Five neurosurgical centers (including one academic and four secondary level care centers) included participants. 211 participants were referred to the Leiden-The Hague Spine Prognostic Study Group. 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were randomized into two groups. Patients and research nurses were blinded for the allocated treatment throughout the study period. 80 participants received an IPD and 79 participants underwent spinal bony decompression. The primary outcome at long-term (2-year) follow-up was the score for the Zurich Claudication Questionnaire. Repeated measurement analyses were applied to compare outcomes over time. RESULTS: At two years, the success rate according to the Zurich Claudication Questionnaire for the IPD group [69 % (95 % CI 57-78 %)] did not show a significant difference compared with standard bony decompression [60 % (95 % CI 48-71 %) p value 0.2]. Reoperations, because of absence of recovery, were indicated and performed in 23 cases (33 %) of the IPD group versus 6 (8 %) patients of the bony decompression group (p < 0.01). Furthermore, long-term VAS back pain was significantly higher [36 mm on a 100 mm scale (95 % CI 24-48)] in the IPD group compared to the bony decompression group [28 mm (95 % CI 23-34) p value 0.04]. CONCLUSIONS: This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional 'simple' decompression, two years after surgery. Moreover, in the IPD treatment arm, the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm.
Authors: James F Zucherman; Ken Y Hsu; Charles A Hartjen; Thomas F Mehalic; Dante A Implicito; Michael J Martin; Donald R Johnson; Grant A Skidmore; Paul P Vessa; James W Dwyer; Stephen T Puccio; Joseph C Cauthen; Richard M Ozuna Journal: Spine (Phila Pa 1976) Date: 2005-06-15 Impact factor: 3.468