IPD without bony decompression versus conventional surgical decompression for lumbar spinal stenosis: 2-year results of a double-blind randomized controlled trial.

Autor:	Moojen, Wouter, Arts, Mark, Jacobs, Wilco, van Zwet, Erik, van den Akker-van Marle, M., Koes, Bart, Vleggeert-Lankamp, Carmen, Peul, Wilco, Moojen, Wouter A, Arts, Mark P, Jacobs, Wilco C H, van Zwet, Erik W, van den Akker-van Marle, M Elske, Koes, Bart W, Vleggeert-Lankamp, Carmen Lam, Peul, Wilco C, Leiden The Hague Spine Intervention Prognostic Study Group (SIPS)
Předmět:	LUMBAR vertebrae surgery COMPARATIVE studies CONFIDENCE intervals DIAGNOSIS FISHER exact test GAIT in humans HEALTH surveys LIFE skills LONGITUDINAL method MEDICAL cooperation PATIENT satisfaction PATIENTS PROBABILITY theory PSYCHOLOGICAL tests QUESTIONNAIRES REOPERATION RESEARCH RESEARCH funding SCALE analysis (Psychology) SCIATICA SPINAL stenosis SURGERY SURGICAL complications SURGICAL clinics MCGILL Pain Questionnaire PAIN measurement RANDOMIZED controlled trials VISUAL analog scale TREATMENT effectiveness REPEATED measures design BLIND experiment SEVERITY of illness index SURGICAL decompression DATA analysis software FUNCTIONAL assessment DESCRIPTIVE statistics ODDS ratio SYMPTOMS
Zdroj:	European Spine Journal; Oct2015, Vol. 24 Issue 10, p2295-2305, 11p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
Externí odkaz:	Zobrazit plný text záznamu Full text from SpringerLink