Original Title: Efectividad de los dispositivos de descompresión interespinosos para el tratamiento de la estenosis sintomática del canal espinal lumbar

Authors' objectives: To confirm the safety and effectiveness of the IDD currently marketed for the treatment of patients with intermittent claudication secondary to lumbar spinal stenosis. Specific objectives: 1. To identify the different types of IDD used internationally, and especially those available in Spain in the last five years. 2. To determine the safety and effectiveness of the IDD in the treatment of patients with symptomatic stenosis of the lumbar spinal canal.

Authors' results and conclusions: RESULTS: We found 1,080 references of published articles, of which 14 met the inclusion criteria. After reviewing the references of primary studies included and the manual searching, two additional references were obtained. Therefore, we eventually included 16 references: two clinical trials described in 4 articles and 11 observational studies or case series described in 12 articles. The two randomized clinical trials evaluated the X-STOP device compared with nonsurgical treatment (which included epidural steroid injection, nonsteroidal anti-inflammatory medication, analgesics and physical therapy agents). Both studies showed that the device is effective for the health outcomes measured by the Zurich Claudication Questionnaire with three dimensions (severity of symptoms, physical function and satisfaction) at one year and two years, both through the comparison between groups and through before-after comparison. The quality of life of patients after surgery, measured by the SF-36, also improved in most of the dimensions. Regarding the radiological measures, no significant changes were observed. No serious complications occurred in relation to the intervention. In addition, we included 11 observational studies described in 12 articles: seven studies evaluated the X-STOP and four other models of IDD. The study designed was case series, prospective or retrospective, except two cohort studies, all of them with a relatively small sample (10 to 45 subjects), with an average age between 61 and 71 years and a follow-up very variable (between 6 and 52 months). In general, the studies showed good results of the IDD on the effectiveness and safety, compared before and after the intervention and with other surgical techniques. However, these results should be interpreted with caution, since these studies do not have experimental design and most of them have a limited sample. CONCLUSIONS: - The systematic review identified scientific data on the effectiveness and safety of different IDD, but most studies are observational and not free from bias. - The level I evidence (randomized clinical trials) exists only on the X-STOP device. The identified studies confirmed the effectiveness and safety of the device in the medium term (two years) compared with conservative treatment, but not with other surgeries. - There is a need of randomized prospective and long-term studies directly comparing the IDD with another minimally invasive surgery in homogeneous groups of patients, from the perspective of effectiveness, security and cost-effectiveness.

Authors' methods: We conducted a systematic review of existing scientific literature on the safety and effectiveness of treatment with IDD of patients with symptomatic stenosis of the lumbar spinal canal, searching in the databases of MEDLINE, EMBASE, SCI, CINAHL and CENTRAL. We included clinical trials (randomized and nonrandomized) and observational studies containing results on the safety and effectiveness of IDD. The quality of included trials was assessed through the CASPE instrument for critical reading of clinical trials. A narrative synthesis was conducted with tabulation of results by subgroups, according to the study design.

Project Status: Completed

Year Published: 2010

URL for published report: https://sescs.es/efectividad-de-los-dispositivos-de-descomprension-interespinosos/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es