Patrick A Brouwer1, Ronald Brand2, M Elske van den Akker-van Marle3, Wilco C H Jacobs4, Barry Schenk1, Annette A van den Berg-Huijsmans1, Bart W Koes5, M A van Buchem1, Mark P Arts6, Wilco C Peul6. 1. Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. 2. Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. 3. Department of Decision Making, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. 4. Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. Electronic address: w.c.h.jacobs@lumc.nl. 5. Department of General Practice, Erasmus MC, University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands. 6. Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands; Department of Neurosurgery, Medical Center Haaglanden The Hague & Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
Abstract
BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/ SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. METHODS: Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.
RCT Entities:
BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/ SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. METHODS:Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.
Authors: Patrick A Brouwer; Ronald Brand; M Elske van den Akker-van Marle; Wilco Ch Jacobs; Barry Schenk; Annette A van den Berg-Huijsmans; Bart W Koes; Mark A Arts; M A van Buchem; Wilco C Peul Journal: Interv Neuroradiol Date: 2017-04-28 Impact factor: 1.610
Authors: M Elske van den Akker-van Marle; Patrick A Brouwer; Ronald Brand; Bart Koes; Wilbert B van den Hout; Mark A van Buchem; Wilco C Peul Journal: Interv Neuroradiol Date: 2017-07-05 Impact factor: 1.610
Authors: Kai-Uwe Lewandrowski; Paulo Sérgio Teixeira de Carvalho; André Luiz Calderaro; Thiago Soares Dos Santos; Marlon Sudário de Lima E Silva; Paulo de Carvalho; Anthony Yeung Journal: J Spine Surg Date: 2020-01