2 research outputs found
Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: Randomized controlled trial
Abstract
Objective To assess whether interspinous process device implantation
is more effective in the short term than conventional surgical
decompression for patients with intermittent neurogenic claudication
due to lumbar spinal stenosis.
Design Randomized controlled trial.
Setting Five neurosurgical centers (including one academic and four
secondary level care centers) in the Netherlands.
Participants 203 participants were referred to the Leiden-The Hague
Spine Prognostic Study Group between October 2008 and September
2011; 159 participants with intermittent neurogenic claudication due to
lumbar spinal stenosis at one or two levels with an indication for surgery
were randomized.
Interventions 80 participants received an interspinous process device
and 79 participants underwent spinal bony decompression.
Main outcome measures The primary outcome at short term (eight
weeks) and long term (one year) follow-up was the Zurich Claudication
Questionnaire score. Repeated measurements were made to compare
outcomes over time.
Results At eight weeks, the success rate according to the Zurich
Claudication Questionnaire for the interspinous process device group
(63%, 95% confidence interval 51% to 73%) was not superior to that for
Introducing new implants and imaging techniques for lumbar spinal stenosis
The main objective of this thesis is to compare bony decompression with implantation of interspinous process devices (IPDs) in patients with intermittent neurogenic claudication (INC) caused by lumbar spinal stenosis (LSS). A national survey among Dutch spine surgeons is presented about the usual care of patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. Surgeons' expectations of different treatment options are presented. The existing evidence on interspinous implant surgery will be systematically reviewed. Results of treatment with IPDs are compared with other (conservative) treatment options. The Foraminal Enlargement Lumbar Interspinosus distraXion (FELIX) trial is described. This double-blind, multicenter, randomized (cost)effectiveness study was designed to answer the question whether treatment with IPDs would be more (cost) effective compared with conventional bony decompression. Short-term results (eight weeks), long-term results (one and two year) and results in different subgroups are described in this thesis. The analysis based on total direct and indirect costs of both procedures (treatment with IPD and bony decompression) are also presented. INC suitable for surgical treatment. The compression on MR images was evaluated and correlated with baseline complaints and long-term clinical outcome.Paradigm spine/InspineUBL - phd migration 201